Gingival InflammationRCTNCT03989427

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

A study testing Brushing first and Flossing later (BF) and Flossing first and Brushing later (FB) in people with Gingival Inflammation and Plaque, run by Melaka Manipal Medical College at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the effectiveness of brushing and flossing sequence in the control of dental plaque and gingival inflammation. Read more about this study

Who is it for?: Ages 18 to 28 yearsHealthy volunteers can take part
Conditions the study is for: Gingival Inflammation, Plaque, Gingival Bleeding
What is being tested?: Brushing first and Flossing later (BF) and Flossing first and Brushing later (FB)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteMalaysia
Study dates: 20 May 2019to 20 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 28 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Dental students of Dental school of Melaka-Manipal Medical College

Who cannot join

Participants who had systemic diseases
Gingivitis or periodontitis
Use of antibiotics in the past 3 months,
Pregnancy,
Smoking
Orthodontic appliances.

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

Faculty of Dentistry, Melaka-Manipal Medical College
Melaka Tengah, Melaka, 57150

Other trials in Malaysia

About this study

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

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

Read the 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.

Conditions: Gingival Inflammation, Plaque, Gingival Bleeding, Plaque Control
Being tested: Brushing first and Flossing later (BF), Flossing first and Brushing later (FB)
Keywords: Gingiva, Gingivitis, Flossing, Brushing, Plaque control, Gingival bleeding, Bleeding point index, Rustogi Modified Navy Plaque Index, Dental Plaque, Tooth brushing
Medical subject headings: Gingivitis, Plaque, Amyloid, Gingival Hemorrhage, Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brushing first and Flossing later (BF)Other
Also called Colgate® tooth brush and Colgate® Dental Floss
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.
Flossing first and Brushing later (FB)Other
Also called Colgate® tooth brush and Colgate® Dental Floss
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.

Study groups in NCT03989427
Study group	Role	What they receive
Brushing First and Flossing Later (BF)	Experimental	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. Receives: Other: Brushing first and Flossing later (BF)
Flossing First and Brushing Later (FB)	Experimental	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. Receives: Other: Flossing first and Brushing later (FB)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 2 weeks

Secondary outcomes (1)

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.
Measured: Baseline and 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 201920 Jan 2020

First posted18 Jun 2019
Study start20 May 2019
Primary completion15 Dec 2019
Study completion20 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Gingival InflammationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
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 blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03989427
Sponsor's protocol ID: MMMC/FOD/AR/B6
Acronym: RCT
Status last verified: May 2020
First submitted: 14 Jun 2019
Last updated: 2 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: If Requested by authors for systematic review, study results will be shared for secondary research.

Publications

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.
PubMed 25197738
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.
PubMed 29741239
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.
PubMed 22814692
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.
PubMed 27513809
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.
PubMed 20657090

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

All Gingival Inflammation trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03989427
Acronym / sponsor ID: RCT / MMMC/FOD/AR/B6
Conditions: Gingival Inflammation, Plaque, Gingival Bleeding, Plaque Control
Keywords: Gingiva, Gingivitis, Flossing, Brushing, Plaque control, Gingival bleeding, Bleeding point index, Rustogi Modified Navy Plaque Index
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Melaka Manipal Medical CollegeUniversity, hospital or other
Collaborators: Colgate Palmolive
Study start: 20 May 2019 (actual)
Primary completion: 15 Dec 2019 (actual)
Study completion: 20 Jan 2020 (actual)
First posted: 18 Jun 2019 (actual)
Results: Posted 2 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
Brushing First and Flossing Later (BF)	Experimental	Other: 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.
Flossing First and Brushing Later (FB)	Experimental	Other: 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.

Who may qualify

Ages: 18 to 28 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Dental students of Dental school of Melaka-Manipal Medical College

Key exclusion criteria (6 listed)

Participants who had systemic diseases
Gingivitis or periodontitis
Use of antibiotics in the past 3 months,
Pregnancy,
Smoking

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Brushing first and Flossing later (BF)Also: Colgate® tooth brush and Colgate® Dental FlossParticipants 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	Brushing First and Flossing Later (BF)
Flossing first and Brushing later (FB)Also: Colgate® tooth brush and Colgate® Dental FlossParticipants 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	Flossing First and Brushing Later (FB)

Primary outcome

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.

1 secondary outcome

Change From Baseline in Mean RMNPI Index Score at 2 Weeks
Time frame: Baseline and 2 weeks

Results and safety

Results posted to the registry on 2 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brushing Flossing (BF)	15	15
Flossing Brushing (FB)	15	15

Primary outcome: Change From Baseline in Mean BPI Index Scores at 2 Weeks

Time frame: Baseline and 2 weeks. Mean (Standard Error). Unit: score on a scale

Measure	Brushing First and Flossing Later (BF) n = 30	Flossing First and Brushing Later (FB) n = 30
Value	0.396 (0.410)	-1.028 (0.392)

Brushing First and Flossing Later (BF) vs Flossing First and Brushing Later (FB): Mean Difference (Net): 1.424 (95% CI 0.221 to 2.628), p = 0.022, ANOVA

Population analysed: All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline, 24 hours, 2 weeks, 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brushing and Flossing	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): There was no article with available to calculate sample size. Hence we conducted the pilot study among 30 participants. We recalculated the sample size from mean and SE of our study. It was estimated to be 40.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25197738Torkzaban 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.
Background: PubMed 29741239Mazhari 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.
Background: PubMed 22814692Zanatta 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.
Background: PubMed 27513809Valkenburg 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.
Background: PubMed 20657090Jayakumar 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.
Individual participant dataSharing planned: Yes. If Requested by authors for systematic review, study results will be shared for secondary research.

Related trials for Gingival Inflammation

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Abdul Rashid Ismail, BDS study director

Melaka Manipal Medical College

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean BPI Index Scores at 2 Weeks (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03989427, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.