Trial Outcomes & Findings for Evaluation of Oral Hygiene Products in an In Situ Caries Model (NCT NCT02399163)
NCT ID: NCT02399163
Last Updated: 2016-05-12
Results Overview
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.
COMPLETED
NA
80 participants
Baseline to 14 days
2016-05-12
Participant Flow
Participants were recruited at one center in United States of America.
A total of 80 participants were screened. Of the 80 participants, 62 were randomized and 53 completed the study.
Participant milestones
| Measure |
Overall Study
In this cross-over study, participants were randomized to receive each of following treatments:
1. Fluoride dentifrice/Fluoride rinse
2. Placebo dentifrice/Fluoride rinse
3. Fluoride dentifrice/No rinse
4. Placebo dentifrice/No rinse
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Overall Study
In this cross-over study, participants were randomized to receive each of following treatments:
1. Fluoride dentifrice/Fluoride rinse
2. Placebo dentifrice/Fluoride rinse
3. Fluoride dentifrice/No rinse
4. Placebo dentifrice/No rinse
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Deviation
|
2
|
|
Overall Study
Withdrawal by Participant
|
5
|
Baseline Characteristics
Evaluation of Oral Hygiene Products in an In Situ Caries Model
Baseline characteristics by cohort
| Measure |
Overall Participants
n=62 Participants
All randomized participants were evaluated for baseline characteristics
|
|---|---|
|
Age, Continuous
|
64.1 Years
STANDARD_DEVIATION 10.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 14 daysPopulation: Per-protocol (PP) population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.
Outcome measures
| Measure |
Placebo Dentifrice/Fluoride Rinse
n=53 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
|
Placebo Dentifrice/No Rinse
n=52 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste
|
Fluoride Dentifrice/No Rinse
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
|
Fluoride Dentifrice/Fluoride Rinse
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
|
|---|---|---|---|---|
|
Percentage Surface Microhardness Recovery (%SMHR) of Placebo Dentifrice/Fluoride Rinse Compared to Placebo Dentifrice/No Rinse
|
24.48 % SMHR
Standard Deviation 16.088
|
8.09 % SMHR
Standard Deviation 25.892
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 14 daysPopulation: PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline(B), indentation length (μm) after in vitro demineralization(D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\]\*100.
Outcome measures
| Measure |
Placebo Dentifrice/Fluoride Rinse
n=53 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
|
Placebo Dentifrice/No Rinse
n=52 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste
|
Fluoride Dentifrice/No Rinse
n=54 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
|
Fluoride Dentifrice/Fluoride Rinse
n=52 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
|
|---|---|---|---|---|
|
Percentage Surface Microhardness Recovery (SMHR) of Placebo Dentifrice/Fluoride Rinse, Placebo Dentifrice/No Rinse, Fluoride Dentifrice/No Rinse and Fluoride Dentifrice/Fluoride Rinse
|
24.48 % SMHR
Standard Deviation 16.088
|
8.09 % SMHR
Standard Deviation 25.892
|
28.36 % SMHR
Standard Deviation 21.037
|
30.01 % SMHR
Standard Deviation 18.203
|
SECONDARY outcome
Timeframe: Baseline to 14 daysPopulation: PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling samples was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm\^2).
Outcome measures
| Measure |
Placebo Dentifrice/Fluoride Rinse
n=53 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
|
Placebo Dentifrice/No Rinse
n=52 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste
|
Fluoride Dentifrice/No Rinse
n=54 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
|
Fluoride Dentifrice/Fluoride Rinse
n=52 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
|
|---|---|---|---|---|
|
Enamel Fluoride Uptake
|
7.22 microgram per square centimeter(μg/cm^2)
Standard Deviation 3.016
|
1.60 microgram per square centimeter(μg/cm^2)
Standard Deviation 0.670
|
8.01 microgram per square centimeter(μg/cm^2)
Standard Deviation 3.925
|
9.97 microgram per square centimeter(μg/cm^2)
Standard Deviation 4.962
|
SECONDARY outcome
Timeframe: Baseline to Day14Population: PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.
Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 baseline prior to supervised treatment. - at day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.
Outcome measures
| Measure |
Placebo Dentifrice/Fluoride Rinse
n=53 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
|
Placebo Dentifrice/No Rinse
n=51 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste
|
Fluoride Dentifrice/No Rinse
n=54 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
|
Fluoride Dentifrice/Fluoride Rinse
n=52 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
|
|---|---|---|---|---|
|
Change in Saliva Fluoride Concentration From Baseline (Pre-treatment) to Day 14
|
0.06 microgram per mililitre(μg/mL )
Standard Deviation 0.317
|
-0.01 microgram per mililitre(μg/mL )
Standard Deviation 0.030
|
0.00 microgram per mililitre(μg/mL )
Standard Deviation 0.245
|
0.06 microgram per mililitre(μg/mL )
Standard Deviation 0.203
|
SECONDARY outcome
Timeframe: Baseline up to Day 14Population: PP population included all participants who were randomized into the study, received at least one dose of study product, had at least one post-baseline efficacy assessment and had no protocol violations deemed to affect efficacy during the study.
Fluoride concentration in saliva was measured after collecting saliva samples at the following time points: - at Day 1 post supervised treatment at site. - at Day 14 post treatment. The amount of fluoride in the samples was calculated based on the amount of fluoride divided by the volume of the sample and expressed as μg/mL of sample.
Outcome measures
| Measure |
Placebo Dentifrice/Fluoride Rinse
n=53 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
|
Placebo Dentifrice/No Rinse
n=51 Participants
Twice daily brushing with a non-fluoride (placebo) toothpaste
|
Fluoride Dentifrice/No Rinse
n=54 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
|
Fluoride Dentifrice/Fluoride Rinse
n=52 Participants
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
|
|---|---|---|---|---|
|
Change in Saliva Fluoride Concentration From Baseline (Post-treatment) to Day 14
|
13.08 μg/mL
Standard Deviation 9.743
|
0.05 μg/mL
Standard Deviation 0.045
|
8.62 μg/mL
Standard Deviation 6.892
|
13.81 μg/mL
Standard Deviation 10.620
|
Adverse Events
Placebo Dentifrice/Fluoride Rinse
Placebo Dentifrice/No Rinse
Fluoride Dentifrice/No Rinse
Fluoride Dentifrice/Fluoride Rinse
Serious adverse events
| Measure |
Placebo Dentifrice/Fluoride Rinse
n=60 participants at risk
Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
|
Placebo Dentifrice/No Rinse
n=56 participants at risk
Twice daily brushing with a non-fluoride (placebo) toothpaste
|
Fluoride Dentifrice/No Rinse
n=59 participants at risk
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
|
Fluoride Dentifrice/Fluoride Rinse
n=57 participants at risk
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
Other adverse events
| Measure |
Placebo Dentifrice/Fluoride Rinse
n=60 participants at risk
Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
|
Placebo Dentifrice/No Rinse
n=56 participants at risk
Twice daily brushing with a non-fluoride (placebo) toothpaste
|
Fluoride Dentifrice/No Rinse
n=59 participants at risk
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
|
Fluoride Dentifrice/Fluoride Rinse
n=57 participants at risk
Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/60
|
3.6%
2/56
|
1.7%
1/59
|
3.5%
2/57
|
|
Gastrointestinal disorders
Tongue Geographic
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
3.5%
2/57
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Gastrointestinal disorders
Lip Dry
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Gastrointestinal disorders
Oral Discomfort
|
1.7%
1/60
|
7.1%
4/56
|
1.7%
1/59
|
1.8%
1/57
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
1.7%
1/60
|
1.8%
1/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Gastrointestinal disorders
Tongue Ulceration
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
1.8%
1/57
|
|
Gastrointestinal disorders
Cheilitis
|
1.7%
1/60
|
3.6%
2/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
Gingival Erythema
|
3.3%
2/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
Gingival Hypertrophy
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
Gingival Oedema
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
Gingival Ulceration
|
0.00%
0/60
|
1.8%
1/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
Lip Ulceration
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
ORAL MUCOSAL ERYTHEMA
|
1.7%
1/60
|
1.8%
1/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Gastrointestinal disorders
TRAUMATIC OCCLUSION
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
5.3%
3/57
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
1.7%
1/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/60
|
1.8%
1/56
|
3.4%
2/59
|
0.00%
0/57
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/60
|
1.8%
1/56
|
1.7%
1/59
|
1.8%
1/57
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/60
|
1.8%
1/56
|
1.7%
1/59
|
1.8%
1/57
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
3.3%
2/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
TONGUE INJURY
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
LACERATION
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
General disorders
INJURY ASSOCIATED WITH DEVICE
|
0.00%
0/60
|
1.8%
1/56
|
3.4%
2/59
|
1.8%
1/57
|
|
General disorders
CHEST PAIN
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
General disorders
MEDICAL DEVICE PAIN
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/60
|
0.00%
0/56
|
0.00%
0/59
|
1.8%
1/57
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
1.7%
1/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Investigations
SMEAR CERVIX ABNORMAL
|
0.00%
0/60
|
0.00%
0/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Nervous system disorders
HEADACHE
|
1.7%
1/60
|
3.6%
2/56
|
1.7%
1/59
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Respiratory, thoracic and mediastinal disorders
THROAT TIGHTNESS
|
1.7%
1/60
|
0.00%
0/56
|
0.00%
0/59
|
0.00%
0/57
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/60
|
1.8%
1/56
|
0.00%
0/59
|
0.00%
0/57
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER