Trial Outcomes & Findings for Prevention of Adult Caries Study (PACS) (NCT NCT00357877)
NCT ID: NCT00357877
Last Updated: 2017-06-14
Results Overview
Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis. This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = -1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
983 participants
Primary outcome timeframe
(V1) to the 13 month follow-up visit
Results posted on
2017-06-14
Participant Flow
Participant milestones
| Measure |
Placebo Dental Coating
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
|
Active Dental Coating (CHX)
Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
|
|---|---|---|
|
Overall Study
STARTED
|
493
|
490
|
|
Overall Study
COMPLETED
|
467
|
460
|
|
Overall Study
NOT COMPLETED
|
26
|
30
|
Reasons for withdrawal
| Measure |
Placebo Dental Coating
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
|
Active Dental Coating (CHX)
Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition. 10% w/v chlorhexidine acetate coating FDA IND #45466.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
20
|
23
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Administrative withdrawal
|
1
|
1
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
Prevention of Adult Caries Study (PACS)
Baseline characteristics by cohort
| Measure |
Placebo Dental Coating
n=493 Participants
Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition
|
Active Dental Coating
n=490 Participants
Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition
|
Total
n=983 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
463 Participants
n=5 Participants
|
459 Participants
n=7 Participants
|
922 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
42.8 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
492 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
491 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
493 participants
n=5 Participants
|
490 participants
n=7 Participants
|
983 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: (V1) to the 13 month follow-up visitPopulation: Intention to treat (ITT) sample. Multiple imputation with 8 datasets imputed via Markov Chain Monte Carlo sampling was used to handle missing data.
Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis. This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = -1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a
Outcome measures
| Measure |
Placebo
n=493 Participants
Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
|
Active
n=490 Participants
Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
|
|---|---|---|
|
Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))
|
2.43 weighted increment units/13 months
Standard Error 0.32
|
2.68 weighted increment units/13 months
Standard Error 0.32
|
SECONDARY outcome
Timeframe: Visit 1, 7-month follow-up, 13-month follow-upPopulation: Intention-to-Treat sample
This measure was computed similar to the total net D12FS increment, but separately scored and combined transitions from the baseline to 7-month visits and from the 7- to 13-month visits, rather than simply looking at the baseline to 13-month visits.
Outcome measures
| Measure |
Placebo
n=493 Participants
Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
|
Active
n=490 Participants
Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
|
|---|---|---|
|
Cumulative Net D12FS Caries Increment
|
5.53 caries increment units/13 months
Standard Error 0.42
|
5.88 caries increment units/13 months
Standard Error 0.43
|
SECONDARY outcome
Timeframe: V1-13-month follow-upPopulation: Intention-to-Treat sample
Computed analogous to the total net D12FS caries increment, but ignoring reversals (essentially assigned them zero weight). Computed only using baseline to 13-month visit data.
Outcome measures
| Measure |
Placebo
n=493 Participants
Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
|
Active
n=490 Participants
Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
|
|---|---|---|
|
Total Crude D12FS Caries Increment
|
6.47 caries increment units/13 months
Standard Error 0.27
|
5.96 caries increment units/13 months
Standard Error 0.28
|
SECONDARY outcome
Timeframe: Visit 1, 7-month follow-up, 13-month follow-upPopulation: Intention-to-Treat sample
This is computed analogous to the cumulative net D12FS increment, but ignoring reversals by assigning them weights of zero.
Outcome measures
| Measure |
Placebo
n=493 Participants
Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
|
Active
n=490 Participants
Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
|
|---|---|---|
|
Cumulative Crude D12FS Caries Increment
|
11.39 caries increment units/13 months
Standard Error 0.42
|
10.72 caries increment units/13 months
Standard Error 0.43
|
Adverse Events
Placebo
Serious events: 31 serious events
Other events: 87 other events
Deaths: 0 deaths
Active
Serious events: 28 serious events
Other events: 84 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=493 participants at risk
Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
|
Active
n=490 participants at risk
Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.41%
2/490 • Number of events 2 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Nervous system disorders
Cerebral ventricle dilation
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Cervical spine stenosis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Psychiatric disorders
Completed suicide
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Nervous system disorders
Convulsion
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Cystitis
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Diverticulitis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Gastrointestinal disorders
Diverticulum
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Social circumstances
Exposure to communicable disease
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Gastroenteritis viral
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Endocrine disorders
Goitre
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Gastrointestinal disorders
Haematochezia
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Surgical and medical procedures
Hernia repair
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Kidney infection
|
0.41%
2/493 • Number of events 2 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Lung injury
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Pneumonia
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.41%
2/490 • Number of events 2 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Pyelonephritis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Surgical and medical procedures
Rectal fistula repair
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Sepsis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Surgical and medical procedures
Urinary bladder excision
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.00%
0/490 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.20%
1/493 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.41%
2/490 • Number of events 2 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/493 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
0.20%
1/490 • Number of events 1 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
Other adverse events
| Measure |
Placebo
n=493 participants at risk
Participants received a placebo dental coating containing no chlorhexidine diacetate (CHX).
|
Active
n=490 participants at risk
Participants received a dental coating containing chlorhexidine diacetate (CHX) 10% weight per volume.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
8.7%
43/493 • Number of events 44 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
6.1%
30/490 • Number of events 31 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Social circumstances
Pharmaceutical product complaint
|
2.4%
12/493 • Number of events 12 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
5.7%
28/490 • Number of events 28 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
6.5%
32/493 • Number of events 36 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
5.3%
26/490 • Number of events 29 • Adverse events were reported at any time throughout the study and were systematically screened for at the 6-month and 1-year visit.
Systematic assessment of adverse events evaluated during routine completion of standard questionnaire.
|
Additional Information
Dr. William Vollmer
Kaiser Permanente Data Coordinating Center
Phone: 503-335-6755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place