Trial Outcomes & Findings for The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation (NCT NCT03989427)
NCT ID: NCT03989427
Last Updated: 2020-06-02
Results Overview
Bleeding on probing (BOP) is an objective indicator of inflammation. BPI (Bleeding Point Index) is a validated index used to measure BOP. BOP is determined at the buccal, lingual and proximal surfaces of all teeth using BPI scores. BPI scores are measured at baseline and 2 weeks, followed by a wash out period of one week. BPI score is measured again at baseline and 2 weeks after cross over in intervention. Change in BPI scores will give the estimation of effect of the intervention. BPI score- minimum value is 0% and Maximum is 100% of bleeding surfaces in each individual patient with teeth. A positive error means that the predicted value is larger than the true value, and a negative error means that the predicted value is less than the true value. The mean error should be close to zero. Sometimes it will be negative or positive depending on the population.. Higher mean score is poor outcome. However, higher reduction in mean score compared to baseline is better outcome.
COMPLETED
NA
30 participants
Baseline and 2 weeks
2020-06-02
Participant Flow
221 students were screened for eligibility between January 25, 2019 to May 10, 2019 in the Out-Patient Department (OPD) of Dept.of Periodontics, Poly clinic A, Klinik Pergigian, Melaka, Malaysia.
30 of 221 participants were randomized. Of those not randomized, 120 did not meet inclusion criteria and 71 declined to participate.
Participant milestones
| Measure |
Brushing Flossing (BF)
Participants used Brushing first and Flossing (BF) sequence in the study. After 1 week wash out period they used Flossing first and brushing (FB) later sequence.
Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.
The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and Spool method of flossing was used.
|
Flossing Brushing (FB)
Participants used Flossing first and brush (FB) later sequence in the study. After 1 week wash out period they used Brushing first and flossing (FB) later sequence.
Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.
The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and Spool method of flossing was used.
|
|---|---|---|
|
First Intervention (2 Weeks)
STARTED
|
15
|
15
|
|
First Intervention (2 Weeks)
COMPLETED
|
15
|
15
|
|
First Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
15
|
15
|
|
Washout (1 Week)
COMPLETED
|
15
|
15
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (2 Weeks)
STARTED
|
15
|
15
|
|
Second Intervention (2 Weeks)
COMPLETED
|
15
|
15
|
|
Second Intervention (2 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation
Baseline characteristics by cohort
| Measure |
Brushing Flossing (BF) First
n=15 Participants
Participants used Brushing first and Flossing later (BF) sequence for 2 weeks. After a washout period of 1 week they used flossing first and brushing later (FB) sequence
Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.
The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head. The method of flossing used was Spool method of flossing.
|
Flossing Brushing (FB) First
n=15 Participants
Participants used Flossing first and Brushing later (FB) sequence for a period of 2 weeks. After a washout period of 1 week they used Brushing first and flossing later (BF) sequence
Toothbrush used was Colgate® tooth brush- Soft bristled, waxed dental floss (Colgate® dental floss) and toothpaste (Colgate® tooth paste) were standardized.
The method of brushing used was Modified Bass Method, the amount of dentifrice used is half-length of the toothbrush's head and the method of flossing used was Spool method of flossing.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.87 Years
STANDARD_DEVIATION 0.52 • n=5 Participants
|
23.00 Years
STANDARD_DEVIATION 0.38 • n=7 Participants
|
22.93 Years
STANDARD_DEVIATION 0.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Malaysian Malay
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Malaysian Chinese
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Malaysian Indians
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
others
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
BPI scores
|
1.8840 units on a scale
STANDARD_DEVIATION 1.765 • n=5 Participants
|
2.5253 units on a scale
STANDARD_DEVIATION 2.388 • n=7 Participants
|
2.2047 units on a scale
STANDARD_DEVIATION 2.089 • n=5 Participants
|
|
RMNPI index scores
|
0.0866 units on a scale
STANDARD_DEVIATION 0.687 • n=5 Participants
|
0.025 units on a scale
STANDARD_DEVIATION 0.020 • n=7 Participants
|
0.080 units on a scale
STANDARD_DEVIATION 0.066 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 weeksPopulation: All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis.
Bleeding on probing (BOP) is an objective indicator of inflammation. BPI (Bleeding Point Index) is a validated index used to measure BOP. BOP is determined at the buccal, lingual and proximal surfaces of all teeth using BPI scores. BPI scores are measured at baseline and 2 weeks, followed by a wash out period of one week. BPI score is measured again at baseline and 2 weeks after cross over in intervention. Change in BPI scores will give the estimation of effect of the intervention. BPI score- minimum value is 0% and Maximum is 100% of bleeding surfaces in each individual patient with teeth. A positive error means that the predicted value is larger than the true value, and a negative error means that the predicted value is less than the true value. The mean error should be close to zero. Sometimes it will be negative or positive depending on the population.. Higher mean score is poor outcome. However, higher reduction in mean score compared to baseline is better outcome.
Outcome measures
| Measure |
Brushing First and Flossing Later (BF)
n=30 Participants
Participants who performed Brushing first and flossing later (BF) in either the first or last 2 weeks of the study
|
Flossing First and Brushing Later (FB)
n=30 Participants
Participants who performed Flossing first and brushing later (FB) in either the first or last 2 weeks of the study.
|
|---|---|---|
|
Change From Baseline in Mean BPI Index Scores at 2 Weeks
|
0.396 score on a scale
Standard Error 0.410
|
-1.028 score on a scale
Standard Error 0.392
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis.
Rustogi Modified Navy Plaque Index(RMNPI) is a self validated tool to assess dental plaque accumulation on the teeth surfaces. RMNPI scores are used to assess change in plaque scores at baseline and at the end of 2 weeks .This will be followed by a 1 week wash out period. Then there is a cross over in the intervention. RMNPI scores are measured again from Baseline and 2 weeks. Maximum number of surfaces examined are 504 per person. A Minimum value of 0 and maximum value of 1 can be calculated in each patient. Higher mean score is a worse outcome. However,higher percent reduction in mean score when compared to baseline is better outcome.
Outcome measures
| Measure |
Brushing First and Flossing Later (BF)
n=30 Participants
Participants who performed Brushing first and flossing later (BF) in either the first or last 2 weeks of the study
|
Flossing First and Brushing Later (FB)
n=30 Participants
Participants who performed Flossing first and brushing later (FB) in either the first or last 2 weeks of the study.
|
|---|---|---|
|
Change From Baseline in Mean RMNPI Index Score at 2 Weeks
|
0.042 score on a scale
Standard Error 1.043
|
0.101 score on a scale
Standard Error 1.427
|
Adverse Events
Brushing and Flossing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place