Gingival Bleeding, Gingival Inflammation, Plaque, Plaque Control
Conditions
Keywords
Gingiva, Gingivitis, Flossing, Brushing, Plaque control, Gingival bleeding, Bleeding point index, Rustogi Modified Navy Plaque Index, Dental Plaque, Tooth brushing
Brief summary
This study evaluates the effectiveness of brushing and flossing sequence in the control of dental plaque and gingival inflammation.
Detailed description
Periodontal disease is the disease of the supporting dental tissues like alveolar bone,periodontal ligament cementum and gingiva. The most common form is plaque-induced gingivitis . Bleeding on gingival probing is one of the hallmarks of gingival inflammation.The removal of dental plaque is the most crucial action for preventing and treating gingival inflammation. Toothbrush along with toothpaste are still the most reliable means of plaque control. However, cleaning should be thorough and performed at regular intervals. Toothbrush has a limited ability to reach all the areas around the tooth. Inter-dental areas are prone for plaque accumulation and gingival inflammation. Dental floss is one of the most effective tool in addition to tooth brush to remove inter-dental plaque. The sequence of using toothbrush and dental floss may influence the removal of dental plaque and consequently reducing the bleeding on probing of gingiva. There is conflicting evidence in the literature. The hypothesis of this study is that the sequence of brushing and flossing will not influence control of plaque control and gingival inflammation.
Interventions
OTHERBrushing first and Flossing later (BF)
Participants will follow Brushing first and flossing later (BF) sequence for 2 weeks, and after 1 week wash out period, Flossing first and Brushing later (FB) sequence for another 2 weeks.
OTHERFlossing first and Brushing later (FB)
Participants will follow Flossing first and Brushing later (FB) sequence for 2 weeks, and after 1 week wash out period, Brushing first and flossing later (BF) sequence for another 2 weeks.
Sponsors
Colgate Palmolive
Melaka Manipal Medical College
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will record measurements at baseline and post intervention. The assessor will be blinded from the sequence of intervention allocation.
Intervention model description
Participants will be selected by random sampling and allocated to Two Arms: Arm-I - Brushing first and Flossing later (BF), Arm II- Flossing first and brushing later (FB) after applying inclusion and exclusion criteria. The participants in BF group will Brush first using Colgate® tooth brush for a 2-week period. and then floss with Colgate® dental floss using Spool method for a 2-week period. This is followed by a one week wash out period After this cross over is done in which participants will change the sequence to FB wherein they will floss first and brush later. The participants in FB group will floss first with Colgate® dental floss and brush later using Colgate® tooth brush for a 2-week period. This is followed by a one week wash out period. After this cross over is done in which participants will change the sequence to BF wherein they will Brush first and Floss later.
Eligibility
Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
Yes
Inclusion criteria
• Dental students of Dental school of Melaka-Manipal Medical College
Exclusion criteria
* Participants who had systemic diseases * Gingivitis or periodontitis * Use of antibiotics in the past 3 months, * Pregnancy, * Smoking * Orthodontic appliances.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean BPI Index Scores at 2 Weeks | Baseline and 2 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean RMNPI Index Score at 2 Weeks | Baseline and 2 weeks | 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. |
Countries
Malaysia
Participant flow
Recruitment details
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.
Pre-assignment details
30 of 221 participants were randomized. Of those not randomized, 120 did not meet inclusion criteria and 71 declined to participate.
Participants by arm
| Arm | Count |
|---|---|
| Brushing Flossing (BF) First 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. | 15 |
| Flossing Brushing (FB) First 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. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Brushing Flossing (BF) First | Flossing Brushing (FB) First | Total |
|---|---|---|---|
| Age, Continuous | 22.87 Years STANDARD_DEVIATION 0.52 | 23.00 Years STANDARD_DEVIATION 0.38 | 22.93 Years STANDARD_DEVIATION 0.45 |
| BPI scores | 1.8840 units on a scale STANDARD_DEVIATION 1.765 | 2.5253 units on a scale STANDARD_DEVIATION 2.388 | 2.2047 units on a scale STANDARD_DEVIATION 2.089 |
| Race/Ethnicity, Customized Malaysian Chinese | 3 participants | 4 participants | 7 participants |
| Race/Ethnicity, Customized Malaysian Indians | 4 participants | 3 participants | 7 participants |
| Race/Ethnicity, Customized Malaysian Malay | 6 participants | 6 participants | 12 participants |
| Race/Ethnicity, Customized others | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Malaysia | 15 participants | 15 participants | 30 participants |
| RMNPI index scores | 0.0866 units on a scale STANDARD_DEVIATION 0.687 | 0.025 units on a scale STANDARD_DEVIATION 0.02 | 0.080 units on a scale STANDARD_DEVIATION 0.066 |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 26 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Change From Baseline in Mean BPI Index Scores at 2 Weeks
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.
Time frame: Baseline and 2 weeks
Population: All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brushing First and Flossing Later (BF) | Change From Baseline in Mean BPI Index Scores at 2 Weeks | 0.396 score on a scale | Standard Error 0.41 |
| Flossing First and Brushing Later (FB) | Change From Baseline in Mean BPI Index Scores at 2 Weeks | -1.028 score on a scale | Standard Error 0.392 |
Comparison: Null hypothesis is that the sequence of brushing first and flossing later has no effect on gingival inflammation.~No previous studies with Mean and SD were available. Hence, a pilot study was done. 30 participants were randomly assigned to Brush first and floss later (BF) group ; and Floss first brush later(FB) group. After 1 week there was cross-over. 80% power is required to detect mean difference in BPI scores.p-value: 0.02295% CI: [0.221, 2.628]ANOVA
Secondary
Change From Baseline in Mean RMNPI Index Score at 2 Weeks
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.
Time frame: Baseline and 2 weeks
Population: All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brushing First and Flossing Later (BF) | Change From Baseline in Mean RMNPI Index Score at 2 Weeks | 0.042 score on a scale | Standard Error 1.043 |
| Flossing First and Brushing Later (FB) | Change From Baseline in Mean RMNPI Index Score at 2 Weeks | 0.101 score on a scale | Standard Error 1.427 |
Comparison: Null hypothesis:~The sequence of brushing and flossing has no effect on plaque scores~There were no previous studies with Mean and SD to calculate sample. So a pilot study was conducted. 30 participants were randomly assigned in 1:1 fashion to Brush-floss (GroupA) and Floss brush group (group B). Then after 1 week there was cross-over among the groups.2 groups would have at least 80% power to detect the mean difference in BPI scores.p-value: 0.97195% CI: [-3.335, 3.219]ANOVA