We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03989427
Recruitment Status : Completed
First Posted : June 18, 2019
Results First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Rajesh Hosadurga, Melaka Manipal Medical College

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

Condition or disease Intervention/treatment Phase
Gingival Inflammation Plaque Gingival Bleeding Plaque Control Other: Brushing first and Flossing later (BF) Other: Flossing first and Brushing later (FB) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.

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.
Primary Purpose: Prevention
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
Actual Study Start Date : May 20, 2019
Actual Primary Completion Date : December 15, 2019
Actual Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brushing First and Flossing Later (BF)
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)
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.
Other Name: Colgate® tooth brush and Colgate® Dental Floss

Experimental: Flossing First and Brushing Later (FB)
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)
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.
Other Name: Colgate® tooth brush and Colgate® Dental Floss




Primary Outcome Measures :
  1. Change From Baseline in Mean BPI Index Scores at 2 Weeks [ Time Frame: 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 Outcome Measures :
  1. Change From Baseline in Mean RMNPI Index Score at 2 Weeks [ Time Frame: 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989427


Locations
Layout table for location information
Malaysia
Faculty of Dentistry, Melaka-Manipal Medical College
Melaka Tengah, Melaka, Malaysia, 57150
Sponsors and Collaborators
Melaka Manipal Medical College
Colgate Palmolive
Investigators
Layout table for investigator information
Study Director: Abdul Rashid Ismail, BDS Melaka Manipal Medical College
  Study Documents (Full-Text)

Documents provided by Rajesh Hosadurga, Melaka Manipal Medical College:
Study Protocol  [PDF] September 4, 2019
Informed Consent Form  [PDF] September 4, 2019
Statistical Analysis Plan  [PDF] January 8, 2020

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Rajesh Hosadurga, Professor, Melaka Manipal Medical College
ClinicalTrials.gov Identifier: NCT03989427    
Other Study ID Numbers: MMMC/FOD/AR/B6
First Posted: June 18, 2019    Key Record Dates
Results First Posted: June 2, 2020
Last Update Posted: June 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: If Requested by authors for systematic review, study results will be shared for secondary research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: January 2020- January 2023
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.


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajesh Hosadurga, Melaka Manipal Medical College:
Gingiva
Gingivitis
Flossing
Brushing
Plaque control
Gingival bleeding
Bleeding point index
Rustogi Modified Navy Plaque Index
Dental Plaque
Tooth brushing
Additional relevant MeSH terms:
Layout table for MeSH terms
Gingivitis
Gingival Hemorrhage
Inflammation
Hemorrhage
Pathologic Processes
Infections
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Oral Hemorrhage
Listerine
Sodium Fluoride
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents