Comparing the Efficacy of Toothbrushing With and Without Interproximal Cleaning Aids: A Split-Mouth Trial

NCT07725276 | Completed DMC

• 1 other identifier: Tfemd-2026-40
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingivitis; Dental Plaque; Periodontal Disease

Keywords

interproximal cleaning; interproximal brush; water flosser; rubber toothpick; toothbrushing; gingival bleeding; gingivitis; dental plaque; papillae loss

Outcome Measures

Primary Outcomes (2)

• Quadrant Plaque Score

  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

  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 Outcomes (2)

• Papilla Harm Score

  Baseline (T0), Day 7, Day 14, and Day 28.

• Motivation Score

  Day 7, Day 14, and Day 28.

Study Arms (4)

Tooth Brushing Alone (Control)

ACTIVE COMPARATOR

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.

Behavioral: Tooth Brushing Alone (Control)

Tooth Brushing + Interproximal Brush (IPB)

EXPERIMENTAL

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

Device: Interproximal Brush

Tooth Brushing + Water Flosser (WF)

EXPERIMENTAL

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.

Device: Water flosser

Tooth Brushing + Rubber Toothpick (RT)

EXPERIMENTAL

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.

Device: Rubber Toothpick

Interventions

Tooth Brushing Alone (Control) BEHAVIORAL

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.

Tooth Brushing Alone (Control)

Water flosser DEVICE

Participants used a water flosser as an adjunct to tooth brushing. The device was applied along the gingival margin using the continuous soft mode.

Tooth Brushing + Water Flosser (WF)

Interproximal Brush DEVICE

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.

Tooth Brushing + Interproximal Brush (IPB)

Rubber Toothpick DEVICE

Participants used a rubber toothpick as an adjunct to tooth brushing for interdental cleaning according to the manufacturer's instructions.

Tooth Brushing + Rubber Toothpick (RT)

Eligibility Criteria

• Age: 20 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• th \& 5th year dental students enrolled at Saint Joseph University of Beirut.
• Participants clinically diagnosed with gingivitis exhibiting fully intact interdental papillae.
• Written informed consent provided and signed before participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Faculty of Dentistry

Beirut, Rue de Damas, 0000, Lebanon

Location

Related Publications (4)

• Yost KG, Mallatt ME, Liebman J. Interproximal gingivitis and plaque reduction by four interdental products. J Clin Dent. 2006;17(3):79-83.

  PMID: 17022370 RESULT

• 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.

  PMID: 27681016 RESULT

• 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.

  PMID: 38997790 RESULT

• 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.

  PMID: 19138181 RESULT

MeSH Terms

Conditions

Gingivitis; Dental Plaque; Periodontal Diseases; Gingival Hemorrhage

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split-mouth randomized controlled trial

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: October 28, 2025
• Primary Completion: March 22, 2026
• Study Completion: April 15, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: upon request
• Access Criteria: upn request lynnkaram001@gmail.com

Locations

LE (1)