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

27. července 2026 aktualizováno: Saint-Joseph University

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.

Přehled studie

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

29

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Rue de Damas
      • Beirut, Rue de Damas, Libanon, 0000
        • Faculty of Dentistry

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Experimentální: 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.
Experimentální: 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.
Experimentální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Quadrant Plaque Score
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Papilla Harm Score
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

28. října 2025

Primární dokončení (Aktuální)

22. března 2026

Dokončení studie (Aktuální)

15. dubna 2026

Termíny zápisu do studia

První předloženo

21. července 2026

První předloženo, které splnilo kritéria kontroly kvality

21. července 2026

První zveřejněno (Aktuální)

24. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

27. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

upon request

Kritéria přístupu pro sdílení IPD

upn request lynnkaram001@gmail.com

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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