Trial Outcomes & Findings for Periodontal Infection and Endothelial Dysfunction (NCT NCT00681564)
NCT ID: NCT00681564
Last Updated: 2014-04-17
Results Overview
All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy
Results posted on
2014-04-17
Participant Flow
rom April 2008 to March 2011 three hundred and six subjects were assessed for eligibility to participate in this randomized clinical trial. One hundred and two patients were randomized to the control (n=55) and treatment group (n=47). At 12 weeks of follow-up, 47 patients (control group) and 41 patients (treatment group) completed the study.
Two hundred and four patients were excluded from this study for the following reasons: no fulfillment of inclusion criteria (n=183), refusal to participate (n=4), not assistance to study appointments (n=15), and another reasons (n=2).
Participant milestones
| Measure |
Periodontal Intervention (Experimental)
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
55
|
|
Overall Study
COMPLETED
|
41
|
47
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Periodontal Intervention (Experimental)
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Periodontal Infection and Endothelial Dysfunction
Baseline characteristics by cohort
| Measure |
Periodontal Intervention (Experimental)
n=47 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=55 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.5 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Indian
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed ethnicity
|
36 participants
n=5 Participants
|
42 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Smoking status
Currently smoking
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Smoking status
Never smoker
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Smoking status
Former smoker
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Formal education
Elementary education (1 to 5 years)
|
14 participants
n=5 Participants
|
17 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Formal education
Secondary education (6 to 11 years)
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Formal education
Higher education (12 or more years)
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Family monthly income
Less than $300 USD
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Family monthly income
≥ $300 and ≤ $600 USD
|
24 participants
n=5 Participants
|
22 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Family monthly income
More than $600 USD
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Medical insurance
None
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Medical insurance
State-subsidized healthcare
|
30 participants
n=5 Participants
|
34 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Medical insurance
Contributory regime (private insurance)
|
11 participants
n=5 Participants
|
15 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Medical insurance
Prepaid medicine plan
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Endothelium-dependent brachial artery flow-mediated dilatation
|
9.9 Percentage of dilation
STANDARD_DEVIATION 7.4 • n=5 Participants
|
9.9 Percentage of dilation
STANDARD_DEVIATION 8.5 • n=7 Participants
|
9.9 Percentage of dilation
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Serum C-reactive protein (CRP)
|
4 mg/L
STANDARD_DEVIATION 7 • n=5 Participants
|
3.1 mg/L
STANDARD_DEVIATION 3.6 • n=7 Participants
|
3.6 mg/L
STANDARD_DEVIATION 5.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapyPopulation: The primary outcome (difference on endothelium-dependent brachial artery FMD at baseline and three months after randomization) and the secondary outcome (hs-CRP, glucose, blood lipid profile and cardiovascular biomarkers) were analyzed using kruskal-wallis and unpaired t test depending on the distribution of the variables.
All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=41 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Brachial Artery Flow-mediated Dilation
12 weeks
|
11.2 Percentage of dilatation of brachial art
Standard Deviation 9.7
|
9.7 Percentage of dilatation of brachial art
Standard Deviation 8.5
|
|
Brachial Artery Flow-mediated Dilation
24 hours
|
13.1 Percentage of dilatation of brachial art
Standard Deviation 9.5
|
8.1 Percentage of dilatation of brachial art
Standard Deviation 7.8
|
|
Brachial Artery Flow-mediated Dilation
Baseline
|
10.2 Percentage of dilatation of brachial art
Standard Deviation 7.3
|
10.3 Percentage of dilatation of brachial art
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapyThe fasting plasma hs-CRP concentrations was evaluated using a quantitative solid-phase, chemiluminescent immunometric assay (Immulite 1000, Siemens).
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=38 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
High-sensitivity C-Reactive Protein
24 hours
|
4.9 mg/L
Standard Deviation 6.7
|
4.1 mg/L
Standard Deviation 4.6
|
|
High-sensitivity C-Reactive Protein
Baseline
|
4.2 mg/L
Standard Deviation 7.5
|
3.1 mg/L
Standard Deviation 3.7
|
|
High-sensitivity C-Reactive Protein
12 weeks
|
3.3 mg/L
Standard Deviation 4.9
|
3.2 mg/L
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapyOutcome measures
| Measure |
Periodontal Intervention (Experimental)
n=40 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Total Cholesterol
Baseline
|
197 mg/dL
Standard Deviation 38.7
|
192.4 mg/dL
Standard Deviation 33.8
|
|
Total Cholesterol
24 hours
|
195.4 mg/dL
Standard Deviation 40.9
|
186.9 mg/dL
Standard Deviation 42.8
|
|
Total Cholesterol
12 weeks
|
203.9 mg/dL
Standard Deviation 35.6
|
200.6 mg/dL
Standard Deviation 39.5
|
SECONDARY outcome
Timeframe: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapyOutcome measures
| Measure |
Periodontal Intervention (Experimental)
n=40 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
White Blood Cell Count
Baseline
|
6937 cells/mm^3
Standard Deviation 2986
|
6380 cells/mm^3
Standard Deviation 1682
|
|
White Blood Cell Count
24 hours
|
6198 cells/mm^3
Standard Deviation 2601
|
6088 cells/mm^3
Standard Deviation 2411
|
|
White Blood Cell Count
12 weeks
|
5464 cells/mm^3
Standard Deviation 3160
|
5382 cells/mm^3
Standard Deviation 2963
|
SECONDARY outcome
Timeframe: 12 weeks post-periodontal therapyPolymerase chain reaction (PCR) was used for detection of the three red-complex periodontal pathogens in periodontal pockets: Porphyromonas gingivalis (Pg), Treponema denticola (Td) and Tannerella forsythia (Tf).
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=39 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=44 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Subgingival Microbiota
Participants positive for Pg, Tf and Td
|
25 participants
|
37 participants
|
|
Subgingival Microbiota
Participants positive for Pg
|
31 participants
|
42 participants
|
|
Subgingival Microbiota
Participants positive for Td
|
31 participants
|
38 participants
|
|
Subgingival Microbiota
Participants positive for Tf
|
34 participants
|
40 participants
|
SECONDARY outcome
Timeframe: Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapyOutcome measures
| Measure |
Periodontal Intervention (Experimental)
n=40 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
LDL Cholesterol
Baseline
|
113.1 mg/dL
Standard Deviation 37.6
|
106.4 mg/dL
Standard Deviation 32.8
|
|
LDL Cholesterol
24 hours
|
111.3 mg/dL
Standard Deviation 41.3
|
104.6 mg/dL
Standard Deviation 33.9
|
|
LDL Cholesterol
12 weeks
|
119.9 mg/dL
Standard Deviation 38.8
|
109.5 mg/dL
Standard Deviation 42.8
|
SECONDARY outcome
Timeframe: 12 weeks post periodontal therapyPopulation: Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.
Multiplexed immuno-cytometric assay for the simultaneous measurement of MMP-9, MPO, tPAI-1, E-Selectin, ICAM-1, and VCAM-1 in serum samples (Milliplex® MAP kit, Human Cardiovascular Disease Panel 1, Millipore®). Luminex® 200™ IS Total System and xPONENT software were used for data acquisition and analysis.
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=38 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Endothelial Leukocyte Adhesion Molecule-1 (E-Selectin)
|
44.8 ng/ml
Standard Deviation 28.7
|
42.9 ng/ml
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: 12 weeks post periodontal therapyPopulation: Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=38 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Intercellular Adhesion Molecule 1 (ICAM-1)
|
247.1 ng/ml
Standard Deviation 196.7
|
235.4 ng/ml
Standard Deviation 229.6
|
SECONDARY outcome
Timeframe: 12 weeks post periodontal therapyPopulation: Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=38 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Vascular Cell Adhesion Molecule 1 (VCAM-1)
|
1601.6 ng/ml
Standard Deviation 372.4
|
1588.1 ng/ml
Standard Deviation 412.3
|
SECONDARY outcome
Timeframe: 12 weeks post periodontal therapyPopulation: Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=38 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Myeloperoxidase (MPO)
|
62.6 ng/ml
Standard Deviation 60.9
|
83.8 ng/ml
Standard Deviation 140.4
|
SECONDARY outcome
Timeframe: 12 weeks post periodontal therapyPopulation: Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=38 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Matrix Metalloproteinase-9 (MMP-9)
|
103.4 ng/ml
Standard Deviation 58.5
|
110.5 ng/ml
Standard Deviation 68.2
|
SECONDARY outcome
Timeframe: 12 weeks post periodontal therapyPopulation: Explanation of missing data in the intervention group: Blood samples obtained from two patients randomized to the periodontal intervention group were not suitable for the Luminex analysis.
Outcome measures
| Measure |
Periodontal Intervention (Experimental)
n=38 Participants
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=46 Participants
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Tissue Plasminogen Activator Inhibitor-1 (tPAI-1)
|
116.1 ng/ml
Standard Deviation 74.1
|
110.7 ng/ml
Standard Deviation 66.4
|
Adverse Events
Periodontal Intervention (Experimental)
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Periodontal Prophylaxis (Active Comparator)
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Periodontal Intervention (Experimental)
n=47 participants at risk
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=55 participants at risk
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Social circumstances
Motor vehicle traffic accident
|
0.00%
0/47 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
1.8%
1/55 • Number of events 1 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
Other adverse events
| Measure |
Periodontal Intervention (Experimental)
n=47 participants at risk
One-Stage Full-Mouth Disinfection: - Scaling and root planing, four quadrants in one session
* Tongue brushing with a 1% chlorhexidine gel (1 minute)
* Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes)
* Subgingival chlorhexidine (1%) irrigation in all pockets
* Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention
* Basic oral hygiene instructions
* Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)
|
Periodontal Prophylaxis (Active Comparator)
n=55 participants at risk
Periodontal care: - Basic oral hygiene instructions
\- Supragingival plaque removal
|
|---|---|---|
|
Surgical and medical procedures
Swelling
|
100.0%
47/47 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
50.9%
28/55 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
|
Surgical and medical procedures
Gingival erythema or bleeding
|
97.9%
46/47 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
43.6%
24/55 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
|
Surgical and medical procedures
Periodontal pain (low-intensity)
|
76.6%
36/47 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
32.7%
18/55 • One day after periodontal therapy
Method for data collection: semi-structured interview and examination of periodontal tissues.
|
Additional Information
Jorge Hernán Ramírez and Adolfo Contreras ([email protected]).
Universidad del Valle
Phone: 5723753778
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place