GingivitisNCT07725276
Comparing the Efficacy of Toothbrushing With and Without Interproximal Cleaning Aids: A Split-Mouth Trial
A study testing Water flosser, Interproximal Brush and Rubber Toothpick in people with Gingivitis and Dental Plaque, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 23 years
- Conditions the study is for
- Gingivitis, Dental Plaque, Periodontal Disease
- What is being tested?
- Water flosser, Interproximal Brush and Rubber Toothpick
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteLebanon
- Study dates
- 28 Oct 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 23 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Gingivitis, Dental Plaque, Periodontal Disease
- Being tested
- Tooth Brushing Alone (Control), Water flosser, Interproximal Brush, Rubber Toothpick
- Keywords
- interproximal cleaning, interproximal brush, water flosser, rubber toothpick, toothbrushing, gingival bleeding, gingivitis, dental plaque, papillae loss
- Medical subject headings
- Gingivitis, Dental Plaque, Periodontal Diseases, Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth Brushing Alone (Control)Behavioural
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.
Water flosserDevice
Participants used a water flosser as an adjunct to tooth brushing. The device was applied along the gingival margin using the continuous soft mode.
Interproximal BrushDevice
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.
Rubber ToothpickDevice
Participants used a rubber toothpick as an adjunct to tooth brushing for interdental cleaning according to the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: 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. Receives: Device: Rubber Toothpick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline (T0), Day 7, Day 14, and Day 28.
Secondary outcomes (2)
Papilla Harm Score
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).
Measured: Baseline (T0), Day 7, Day 14, and Day 28.
Motivation Score
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.
Measured: Day 7, Day 14, and Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start28 Oct 2025
- Primary completion22 Mar 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725276
- Sponsor's protocol ID
- Tfemd-2026-40
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) supporting the reported study results will be shared. The shared data may include demographic characteristics, baseline clinical measurements, Quadrant Plaque Score (QPS), Quadrant Bleeding Score (QBS), Papilla Harm (PH) scores, motivation scores, intervention allocation, and follow-up assessment results at each study time point (T0, T7, T14, and T28). All shared data will be anonymized to protect participant confidentiality and will be provided for research purposes upon reasonable request.
Publications
Yost KG, Mallatt ME, Liebman J. Interproximal gingivitis and plaque reduction by four interdental products. J Clin Dent. 2006;17(3):79-83.
PubMed 17022370Bourgeois 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.
PubMed 27681016Mancinelli-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.
PubMed 38997790Husseini 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.
PubMed 19138181
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Toothbrushing With and Without Interproximal Cleaning Aids Among Dental Students: A Split-Mouth Clinical Trial.
- ClinicalTrials.gov ID
- NCT07725276
- Acronym / sponsor ID
- Tfemd-2026-40
- Conditions
- Gingivitis, Dental Plaque, Periodontal Disease
- Keywords
- interproximal cleaning, interproximal brush, water flosser, rubber toothpick, toothbrushing, gingival bleeding, gingivitis, dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 22 Mar 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Split-mouth randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Tooth Brushing Alone (Control) | Active comparator | Behavioral: 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. |
| Tooth Brushing + Interproximal Brush (IPB) | Experimental | Device: Interproximal BrushParticipants 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 |
| Tooth Brushing + Water Flosser (WF) | Experimental | Device: Water flosserParticipants 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. |
| Tooth Brushing + Rubber Toothpick (RT) | Experimental | Device: Rubber ToothpickParticipants 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. |
Who may qualify
- Ages
- 20 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | Tooth Brushing Alone (Control) |
| Water flosserParticipants used a water flosser as an adjunct to tooth brushing. The device was applied along the gingival margin using the continuous soft mode. | Device | Tooth Brushing + Water Flosser (WF) |
| Interproximal BrushParticipants 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. | Device | Tooth Brushing + Interproximal Brush (IPB) |
| Rubber ToothpickParticipants used a rubber toothpick as an adjunct to tooth brushing for interdental cleaning according to the manufacturer's instructions. | Device | Tooth Brushing + Rubber Toothpick (RT) |
Primary outcome
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).
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).
2 secondary outcomes
Papilla Harm Score
Time frame: Baseline (T0), Day 7, Day 14, and Day 28.
Motivation Score
Time frame: Day 7, Day 14, and Day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Results publication: PubMed 17022370Yost KG, Mallatt ME, Liebman J. Interproximal gingivitis and plaque reduction by four interdental products. J Clin Dent. 2006;17(3):79-83.
- Results publication: PubMed 27681016Bourgeois 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.
- Results publication: PubMed 38997790Mancinelli-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.
- Results publication: PubMed 19138181Husseini 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) supporting the reported study results will be shared. The shared data may include demographic characteristics, baseline clinical measurements, Quadrant Plaque Score (QPS), Quadrant Bleeding Score (QBS), Papilla Harm (PH) scores, motivation scores, intervention allocation, and follow-up assessment results at each study time point (T0, T7, T14, and T28). All shared data will be anonymized to protect participant confidentiality and will be provided for research purposes upon reasonable request.
Related trials for Gingivitis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water flosser, Interproximal Brush and Rubber Toothpick in people with Gingivitis and Dental Plaque, run by Saint-Joseph University at 1 site in Lebanon.
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 4 inclusion and 7 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 28 Jul 2026. 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 Lebanon. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quadrant Plaque Score (time frame: Baseline (T0), Day 7, Day 14, and Day 28.). The study lists 2 primary outcomes in all. 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 NCT07725276, which also lists 4 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 28 Jul 2026.