Comparing the Efficacy of Toothbrushing With and Without Interproximal Cleaning Aids: A Split-Mouth Trial
Comparing the Efficacy of Toothbrushing With and Without Interproximal Cleaning Aids Among Dental Students: A Split-Mouth Clinical Trial.
The goal of this prospective clinical trial is to evaluate whether adding interproximal cleaning aids (interproximal brush, rubber toothpick, water flosser) to regular tooth brushing improves oral hygiene outcomes and gingival health compared with tooth brushing alone in dental students with gingivitis and intact interdental papillae. The main questions it aims to answer are:
- Does the addition of interproximal cleaning aids to tooth brushing result in greater reduction of dental plaque accumulation compared with tooth brushing alone?
- Does the use of interproximal cleaning aids improve gingival bleeding outcomes compared with tooth brushing alone?
- Does the use of interproximal cleaning aids affect interdental papilla health and cause soft tissue trauma or damage?
- Do different interproximal cleaning aids influence participants' motivation and adherence to oral hygiene practices?
Researchers will compare tooth brushing alone with tooth brushing combined with three different interproximal cleaning aids (interdental brush, water flosser, and rubber toothpick) to determine whether these adjunctive methods provide additional benefits in plaque control, gingival health, preservation of interdental soft tissues, and participant motivation.
Participants will:
- Perform standardized tooth brushing using the modified Bass technique twice daily.
- Use the assigned interproximal cleaning aid (interdental brush, water flosser, or rubber toothpick) in designated quadrants according to standardized instructions.
- Attend clinical evaluations at baseline and after 7, 14, and 28 days.
- Undergo assessment of dental plaque score, gingival bleeding score, interdental papilla condition, and motivation related to oral hygiene practices.
Study Overview
Status
Conditions
Detailed Description
This prospective split-mouth clinical trial aims to evaluate the effectiveness and safety of different interproximal cleaning aids used in addition to toothbrushing compared with toothbrushing alone in dental students diagnosed with gingivitis and presenting with intact interdental papillae.
The study will investigate whether toothbrushing alone, when performed using a standardized and effective technique, is sufficient for maintaining plaque control and gingival health, or whether the addition of interproximal cleaning devices provides further clinical benefits. The study will also assess the potential impact of these devices on interdental papilla integrity, possible soft tissue trauma, and participant motivation and adherence.
Participants will be dental students enrolled at Saint Joseph University of Beirut who meet the eligibility criteria. Eligible participants will present with gingivitis, intact interdental papillae, and no periodontal attachment loss or conditions that may interfere with periodontal health assessment. Participants with orthodontic appliances, crowns, implants, dentures, periodontitis, diastemas, systemic conditions affecting periodontal health, or medications causing gingival enlargement will be excluded.
Each participant's mouth will be divided into four quadrants in a split-mouth design. A computer-generated randomization sequence will determine the starting position of the assigned interventions to minimize site-related bias. Each quadrant will receive one of the following oral hygiene protocols:
- Quadrant 1: Toothbrushing alone (control).
- Quadrant 2: Toothbrushing combined with an interproximal brush (IPB).
- Quadrant 3: Toothbrushing combined with a water flosser (WF).
- Quadrant 4: Toothbrushing combined with a rubber toothpick (RT).
All participants will receive standardized oral hygiene instructions and a dental kit containing a soft toothbrush, fluoride toothpaste, interproximal brush, water flosser, and rubber toothpick. Participants will perform the modified Bass toothbrushing technique twice daily, in the morning and after the last meal of the day, for a period of one month (4 weeks).
For the interproximal brush group, participants will perform gentle back-and-forth movements five times in each interdental space. For the water flosser group, participants will direct the irrigator tip along the gingival margin and interdental papillae using continuous flow mode while avoiding direct contact with gingival tissues. For the rubber toothpick group, participants will perform gentle back-and-forth movements five times in each interdental space.
Clinical evaluations will be performed at four time points:
- T0: baseline before the use of interproximal cleaning aids.
- T7: one week after intervention initiation.
- T14: two weeks after intervention initiation.
- T30: one month after intervention initiation.
The primary outcomes will include:
- Quadrant Plaque Score (QPS) to evaluate plaque accumulation.
- Quadrant Bleeding Score (QBS) to assess gingival inflammation.
Secondary outcomes will include:
- Interdental papilla assessment using the Papilla Presence Index (PPI) to evaluate papillary changes and potential soft tissue damage.
- Participant motivation and satisfaction scores based on a 1-10 subjective scale evaluating ease of use, comfort, and adherence to each cleaning method.
All clinical measurements will be performed by the same calibrated examiner using a Hu-Friedy PCPUNC 15 periodontal probe. The study will provide comparative data regarding the effectiveness, safety, and acceptability of commonly used interproximal cleaning devices in individuals with gingivitis and good oral hygiene skills.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rue de Damas
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Beirut, Rue de Damas, Lebanon, 0000
- Faculty of Dentistry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 4th & 5th year dental students enrolled at Saint Joseph University of Beirut.
- Participants clinically diagnosed with gingivitis exhibiting fully intact interdental papillae.
- Participants who had undergone a dental cleaning session 6 weeks before inclusion in the study.
- Written informed consent provided and signed before participation.
Exclusion Criteria:
- Participants with fixed or removable orthodontic appliances, crowns, dental implants, or dentures.
- Participants diagnosed with periodontitis.
- Participants with reduced or absent interdental papillae.
- Individuals with poor oral hygiene practices, including irregular or inadequate toothbrushing.
- Participants currently taking medications known to induce gingival hyperplasia or hypertrophy.
- Presence of diastemas or open contacts between adjacent teeth in the areas to be assessed.
- Individuals with systemic diseases or medical conditions that may affect gingival or periodontal health.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Tooth Brushing Alone (Control)
Participants received standardized tooth brushing instructions using the Modified Bass technique twice daily after the last meal.
No additional interproximal cleaning aid was used.
This arm served as the control group for comparison with adjunctive interproximal cleaning interventions.
|
Participants received standardized tooth brushing instructions using the Modified Bass technique twice daily after the last meal.
No additional interproximal cleaning aid was used.
This arm served as the control group for comparison with adjunctive interproximal cleaning interventions.
|
|
Experimental: Tooth Brushing + Interproximal Brush (IPB)
Participants used an interproximal brush as an adjunct to standardized tooth brushing.
The interproximal brush was inserted into interdental spaces and moved back and forth five times per site, in addition to twice-daily Modified Bass tooth brushing
|
Participants used an interproximal brush as an adjunct to tooth brushing.
The brush was inserted into interdental spaces and moved back and forth five times per site.
|
|
Experimental: Tooth Brushing + Water Flosser (WF)
Participants used a water flosser as an adjunct to standardized tooth brushing.
The device was applied along the gingival margin using the continuous soft mode, in addition to twice-daily Modified Bass tooth brushing.
|
Participants used a water flosser as an adjunct to tooth brushing.
The device was applied along the gingival margin using the continuous soft mode.
|
|
Experimental: Tooth Brushing + Rubber Toothpick (RT)
Participants used a rubber toothpick as an adjunct to standardized tooth brushing.
The rubber toothpick was used for interdental cleaning according to the manufacturer's instructions, in addition to twice-daily Modified Bass tooth brushing.
|
Participants used a rubber toothpick as an adjunct to tooth brushing for interdental cleaning according to the manufacturer's instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quadrant Plaque Score
Time Frame: Baseline (T0), Day 7, Day 14, and Day 28.
|
The effectiveness of each oral hygiene intervention in reducing dental plaque accumulation will be assessed using the Quadrant Plaque Score (QPS), derived from the Full-Mouth Plaque Score (FMPS; O'Leary Plaque Index).
The QPS is expressed as the percentage of tooth surfaces with visible dental plaque within each quadrant, with scores ranging from 0% to 100%.
Higher scores indicate greater plaque accumulation (worse oral hygiene), whereas lower scores indicate less plaque accumulation (better oral hygiene).
Plaque levels will be recorded at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28).
Changes in QPS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
|
Baseline (T0), Day 7, Day 14, and Day 28.
|
|
Quadrant Bleeding Score
Time Frame: Baseline (T0), Day 7, Day 14, and Day 28.
|
he effect of each oral hygiene intervention on gingival inflammation will be assessed using the Quadrant Bleeding Score (QBS), derived from the Full-Mouth Bleeding Score (FMBS).
The QBS is expressed as the percentage of periodontal sites exhibiting bleeding on probing within each quadrant, with scores ranging from 0% to 100%.
Higher scores indicate greater gingival inflammation (worse gingival health), whereas lower scores indicate less gingival inflammation (better gingival health).
Gingival bleeding will be recorded following periodontal probing at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention.
Changes in QBS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
|
Baseline (T0), Day 7, Day 14, and Day 28.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Papilla Harm Score
Time Frame: Baseline (T0), Day 7, Day 14, and Day 28.
|
The effect of each oral hygiene intervention on interdental soft tissue integrity will be assessed using the Papilla Harm (PH) score.
The Papilla Harm score evaluates the presence and severity of interdental papillary trauma following the use of interproximal cleaning aids.
Scores range from 0 to 4, where a score of 0 indicates no papillary trauma and higher scores indicate increasing severity of papillary injury (worse interdental soft tissue integrity).
The presence and severity of papillary trauma will be evaluated at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention.
Changes in PH scores over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
|
Baseline (T0), Day 7, Day 14, and Day 28.
|
|
Motivation Score
Time Frame: Day 7, Day 14, and Day 28.
|
Participant-reported motivation and acceptance of each oral hygiene intervention will be assessed using a Numerical Rating Scale (NRS) ranging from 1 to 10.
A score of 1 represents the lowest level of motivation/acceptance, while a score of 10 represents the highest level of motivation/acceptance.
Higher scores indicate greater motivation and acceptance of the assigned cleaning method (better outcome), whereas lower scores indicate lower motivation and acceptance.
Motivation scores will be recorded at 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention.
Differences in motivation levels between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick) will be evaluated.
|
Day 7, Day 14, and Day 28.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Yost KG, Mallatt ME, Liebman J. Interproximal gingivitis and plaque reduction by four interdental products. J Clin Dent. 2006;17(3):79-83.
- Bourgeois D, Saliasi I, Llodra JC, Bravo M, Viennot S, Carrouel F. Efficacy of interdental calibrated brushes on bleeding reduction in adults: a 3-month randomized controlled clinical trial. Eur J Oral Sci. 2016 Dec;124(6):566-571. doi: 10.1111/eos.12302. Epub 2016 Sep 29.
- Mancinelli-Lyle D, Van der Weijden FGA, Slot DE. Efficacy of a water flosser compared to an interdental brush on gingival bleeding and gingival abrasion: A 4 week randomized controlled trial. Int J Dent Hyg. 2025 Feb;23(1):176-185. doi: 10.1111/idh.12817. Epub 2024 Jul 12.
- Husseini A, Slot DE, Van der Weijden GA. The efficacy of oral irrigation in addition to a toothbrush on plaque and the clinical parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008 Nov;6(4):304-14. doi: 10.1111/j.1601-5037.2008.00343.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mouth Diseases
- Stomatognathic Diseases
- Pathologic Processes
- Tooth Diseases
- Infections
- Hemorrhage
- Gingival Diseases
- Dental Deposits
- Oral Hemorrhage
- Pathological Conditions, Signs and Symptoms
- Dental Plaque
- Periodontal Diseases
- Gingivitis
- Gingival Hemorrhage
- Dentistry
- Preventive Dentistry
- Oral Hygiene
- Toothbrushing
Other Study ID Numbers
- Tfemd-2026-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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