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

Primary Purpose

Gingival Inflammation, Plaque, Gingival Bleeding

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Brushing first and Flossing later (BF)
Flossing first and Brushing later (FB)
Sponsored by
Melaka Manipal Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Inflammation focused on measuring Gingiva, Gingivitis, Flossing, Brushing, Plaque control, Gingival bleeding, Bleeding point index, Rustogi Modified Navy Plaque Index, Dental Plaque, Tooth brushing

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry, Melaka-Manipal Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Brushing First and Flossing Later (BF)

Flossing First and Brushing Later (FB)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 14, 2019
Last Updated
May 30, 2020
Sponsor
Melaka Manipal Medical College
Collaborators
Colgate Palmolive
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1. Study Identification

Unique Protocol Identification Number
NCT03989427
Brief Title
The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation
Acronym
RCT
Official Title
The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation-A Randomized Controlled Clinical Trial in Klinik Pergigian, MMMC, Melaka
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Melaka Manipal Medical College
Collaborators
Colgate Palmolive

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Inflammation, Plaque, Gingival Bleeding, Plaque Control
Keywords
Gingiva, Gingivitis, Flossing, Brushing, Plaque control, Gingival bleeding, Bleeding point index, Rustogi Modified Navy Plaque Index, Dental Plaque, Tooth brushing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brushing First and Flossing Later (BF)
Arm Type
Experimental
Arm Description
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.
Arm Title
Flossing First and Brushing Later (FB)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Brushing first and Flossing later (BF)
Other Intervention Name(s)
Colgate® tooth brush and Colgate® Dental Floss
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Flossing first and Brushing later (FB)
Other Intervention Name(s)
Colgate® tooth brush and Colgate® Dental Floss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean BPI Index Scores at 2 Weeks
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean RMNPI Index Score at 2 Weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Rashid Ismail, BDS
Organizational Affiliation
Melaka Manipal Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Melaka-Manipal Medical College
City
Melaka Tengah
State/Province
Melaka
ZIP/Postal Code
57150
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
If Requested by authors for systematic review, study results will be shared for secondary research.
IPD Sharing Time Frame
January 2020- January 2023
IPD Sharing Access Criteria
IPD access will be given only to bona fide research groups as evidenced via their resume and the involvement of a qualified statistician. Consent will be taken from the participants about data sharing prior to the commencement of the study. Confidentiality will be strictly maintained. Data custodians are scientific committee, Faculty of Dentistry, MMMC, Melaka. Data access will be reviewed and approved by DRC based on Merits of requests.
Citations:
PubMed Identifier
25197738
Citation
Torkzaban P, Arabi SR, Sabounchi SS, Roshanaei G. The Efficacy of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation. Oral Health Prev Dent. 2015;13(3):267-73. doi: 10.3290/j.ohpd.a32678.
Results Reference
background
PubMed Identifier
29741239
Citation
Mazhari F, Boskabady M, Moeintaghavi A, Habibi A. The effect of toothbrushing and flossing sequence on interdental plaque reduction and fluoride retention: A randomized controlled clinical trial. J Periodontol. 2018 Jul;89(7):824-832. doi: 10.1002/JPER.17-0149. Epub 2018 Jul 20.
Results Reference
background
PubMed Identifier
22814692
Citation
Zanatta FB, Antoniazzi RP, Pinto TM, Rosing CK. Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial. Braz Dent J. 2012;23(3):235-40. doi: 10.1590/s0103-64402012000300009.
Results Reference
background
PubMed Identifier
27513809
Citation
Valkenburg C, Slot DE, Bakker EW, Van der Weijden FA. Does dentifrice use help to remove plaque? A systematic review. J Clin Periodontol. 2016 Dec;43(12):1050-1058. doi: 10.1111/jcpe.12615. Epub 2016 Oct 3.
Results Reference
background
PubMed Identifier
20657090
Citation
Jayakumar A, Padmini H, Haritha A, Reddy KP. Role of dentifrice in plaque removal: a clinical trial. Indian J Dent Res. 2010 Apr-Jun;21(2):213-7. doi: 10.4103/0970-9290.66629.
Results Reference
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The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation

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