The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation

Study Overview
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Brief Summary
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This study evaluates the effectiveness of brushing and flossing sequence in the control of dental plaque and gingival inflammation.

Detailed Description
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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.

Official Title
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The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation-A Randomized Controlled Clinical Trial in Klinik Pergigian, MMMC, Melaka

Conditions
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Gingival Inflammation, Plaque, Gingival Bleeding, Plaque Control

Intervention / Treatment
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* Other: Brushing first and Flossing later (BF)
* Other: Flossing first and Brushing later (FB)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brushing First and Flossing Later (BF)<br>The participants in BF group were asked to use modified bass method of tooth brushing first using Colgate® tooth brush (the amount of Colgate® tooth paste used is half-length of the toothbrush's head) 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 wherein they will practice oral hygiene according to their habitual method. After this cross over is done in which participants will change the sequence to FB wherein they will floss first and brush later. | Other: Brushing first and Flossing later (BF)<br>* 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.<br>* Other names: Colgate® tooth brush and Colgate® Dental Floss;|
| Experimental: Flossing First and Brushing Later (FB)<br>The participants in FB group were asked to floss first with Colgate® dental floss using Spool method and then modified bass method of tooth brushing first using Colgate® tooth brush (the amount of Colgate® tooth paste used is half-length of the toothbrush's head) for a 2-week period. This is followed by a one week wash out period wherein they will practice oral hygiene according to their habitual method. After this cross over is done in which participants will change the sequence to BF wherein they will brush first and floss later. | Other: Flossing first and Brushing later (FB)<br>* 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.<br>* Other names: Colgate® tooth brush and Colgate® Dental Floss;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gingiva, Gingivitis, Flossing, Brushing, Plaque control, Gingival bleeding, Bleeding point index, Rustogi Modified Navy Plaque Index, Dental Plaque, Tooth brushing