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| Name | Class |
|---|---|
| Colgate Palmolive | INDUSTRY |
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This study evaluates the effectiveness of brushing and flossing sequence in the control of dental plaque and gingival inflammation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brushing first and Flossing later (BF) | Other | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
• Dental students of Dental school of Melaka-Manipal Medical College
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abdul Rashid Ismail, BDS | Melaka Manipal Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Melaka-Manipal Medical College | Melaka Tengah | Melaka | 57150 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25197738 | Background | 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. | |
| 29741239 | Background | 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. |
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If Requested by authors for systematic review, study results will be shared for secondary research.
January 2020- January 2023
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.
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30 of 221 participants were randomized. Of those not randomized, 120 did not meet inclusion criteria and 71 declined to participate.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brushing Flossing (BF) | Participants used Brushing first and Flossing (BF) sequence in the study. After 1 week wash out period they used Flossing first and brushing (FB) later 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 Spool method of flossing was used. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (2 Weeks) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2019 | Apr 23, 2020 |
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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.
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The outcome assessor will record measurements at baseline and post intervention. The assessor will be blinded from the sequence of intervention allocation.
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| Flossing first and Brushing later (FB) | Other | 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. |
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| Baseline and 2 weeks |
| 22814692 | Background | 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. |
| 27513809 | Background | 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. |
| 20657090 | Background | 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. |
| FG001 | Flossing Brushing (FB) | Participants used Flossing first and brush (FB) later sequence in the study. After 1 week wash out period they used Brushing first and flossing (FB) later 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 Spool method of flossing was used. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout (1 Week) |
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| Second Intervention (2 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| BPI scores | Bleeding on probing will determined at the buccal, lingual and proximal surfaces using the Changes in BPI (Bleeding on probing index ) scores will be used to assess change in bleeding on probing scores at baseline and end of the 1st phase of the study( where the participants will brush first and then floss) and at the end of the 2nd phase (where the participants will floss first and brush later). BPI score- minimum value is 0% and Maximum is 100% of bleeding surfaces. Higher mean score is poor outcome. However, higher reduction in mean score compared to baseline is better outcome. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| RMNPI index scores | Rustogi Modified Navy Plaque Index(RMNPI) is used to assess change in plaque scores at baseline. Maximum number of surfaces examined are 504. Minimum value is 0 and maximum value is 1 in each patient. The measure of dispersion used was Mean and Standard error. 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 true value. The mean error should be close to zero. Higher mean score is a worse outcome.Higher percent reduction in mean score when compared to baseline is better outcome. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis. | Posted | Mean | Standard Error | score on a scale | Baseline and 2 weeks |
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| 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. | All participants who received at least one intervention each and completed all study visits were included in the effectiveness analysis. | Posted | Mean | Standard Error | score on a scale | Baseline and 2 weeks |
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Baseline, 24 hours, 2 weeks, 5 weeks
We followed the description provided by clinical trials. gov. Adverse event and serious adverse event was recorded in our data collection sheet for each participant. Checklist was prepared for each participant and attached to the data form. The data was recorded at baseline examination carried out in the morning clinical session, the participants were reviewed after 24 hours, 2 weeks and 5 weeks. They were asked to report immediately if any adverse events occurred in other periods of time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brushing and Flossing | No adverse events were reported | 0 | 30 | 0 | 30 | 0 | 30 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajesh Hosadurga | Melaka-Manipal Medical College | +6062896662 | 3823 | rajesh.hosadurga@manipal.edu.my |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2019 | Apr 23, 2020 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2020 | Apr 29, 2020 | SAP_002.pdf |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| D058225 | Plaque, Amyloid |
| D005884 | Gingival Hemorrhage |
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006472 | Oral Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
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| Male |
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| Malaysian Chinese |
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| Malaysian Indians |
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| others |
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| Equivalence |
The two treatment sequence could be called equivalent if the observed difference and its 95% CI are completely inside the interval of clinical equivalence. A significant result (p < 0.05) means that the two treatments are equivalent, according the definition of equivalence as defined clinically. |
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