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Touch-to-Teach Interdental Brush Instruction Versus Conventional Guidance on Gingival Health in Patients With Fixed Dental Prostheses

7 giugno 2026 aggiornato da: Gulf Medical University

Assessing the Impact of Interdental Brushing on Gingival Health and Patient-Reported Outcome Measures in Individuals With Fixed Prostheses: A Single-Blind Randomized Controlled Clinical Trial

Why is this study being done? People with dental crowns often develop inflamed gums because bacteria accumulate in the tight spaces between teeth that a regular toothbrush cannot reach. Interdental brushes can clean these spaces, but patients frequently use them incorrectly. This study tested whether a personalised, hands-on instructional method called Touch-to-Teach produces healthier gums compared with standard dental hygiene advice.

Who participated? 40 adults with at least one porcelain-fused-to-metal crown in the molar region with supragingival margins took part at Thumbay University Hospital, Ajman, UAE. Four participants withdrew; 36 completed the three-month study.

What did participants do? All participants received full-mouth scaling and standardised toothbrushing instruction. Group 1 (Touch-to-Teach) additionally received probe-guided, site-specific interdental brush selection and guided in-mouth training, with correctly sized brushes provided for home use. Group 2 (Conventional Instruction) received verbal advice, educational videos, and a model-based demonstration, with brush size selected empirically and no brushes provided for home use. Follow-up visits were conducted at one, two, and three months.

What was measured? A blinded examiner recorded gum inflammation, plaque levels, gum pocket depth, and bleeding at each visit. Both groups completed a questionnaire on brush comfort, perceived efficacy, and satisfaction at one and three months.

What were the key results? The Touch-to-Teach group showed significantly greater reductions in plaque accumulation, gingival inflammation, and probing depth compared with the control group. Both groups showed meaningful reductions in gingival bleeding over time, with no statistically significant difference between groups at three months. Patient-reported outcomes consistently favoured the Touch-to-Teach group. These findings suggest that calibrated, personalised interdental brush instruction may offer advantages for patients with fixed dental prostheses.

Panoramica dello studio

Descrizione dettagliata

Background Patients with fixed dental prostheses are at increased risk of interproximal plaque accumulation due to altered crown contour and interdental geometry. Although interdental brushes are the most effective adjunct to toothbrushing for interproximal plaque removal, no randomised trial had previously evaluated the impact of instructional method on gingival outcomes in this patient population. The Touch-to-Teach method combines chairside probe-guided brush size calibration with hands-on guided in-mouth training, offering a more individualised approach than conventional model-based instruction.

Study Design Single-blind, parallel-group randomised controlled trial conducted at Thumbay University Hospital, Ajman, UAE. Ethics approval: IRB-COD-STD-69-FEB-2024. Written informed consent obtained from all participants prior to enrolment.

Interventions All participants received standardised full-mouth debridement and toothbrushing instruction before baseline. The test group received probe-guided, site-specific interdental brush selection using the Curaprox CPS Colorimetric Probe System, followed by guided in-mouth training until proficiency was demonstrated; size-calibrated brushes were provided for home use. The control group received empirical brush size selection, verbal instruction, access to EFP patient portal educational videos, and model-based demonstration; no brushes were provided for home use.

Outcomes Primary outcome: change in Gingival Index from baseline to three months. Secondary outcomes: Plaque Index, Bleeding on Probing, Probing Depth, and patient-reported outcome measures, assessed at baseline, one, two, and three months by a blinded examiner.

Sample Size Minimum 32 participants required (α = 0.05, power = 80%). Inflated by 25% to 40 participants to account for attrition. Sixty patients screened; 40 enrolled; 36 completed the three-month follow-up (18 per group; 4 withdrew).

Statistical Analysis Continuous outcomes analysed using independent t-tests or Mann-Whitney U test depending on normality. Categorical variables compared using Fisher's exact test. Intragroup BOP changes assessed using Cochran's Q test. Multiple comparisons corrected using Holm's sequential method. Significance set at p < 0.05. Analyses performed in R version 4.3.2.You've used 75% of your weekly limitGet more usageSonnet 4.6Adaptive

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Ajman Emirate
      • Ajman, Ajman Emirate, Emirati Arabi Uniti
        • ostgraduate Dental Center, Thumbay University Hospital, Gulf Medical University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Adults aged 18 years and older
  • Presence of at least one porcelain-fused-to-metal (PFM) crown in the molar region with supragingival margins, in occlusal function for a minimum of 3 months prior to enrollment
  • Prosthesis does not interfere with the supracrestal attachment apparatus (biologic width preserved)
  • Clinically healthy periodontium confirmed at screening, with no signs of periodontal disease as per the 2017 World Workshop classification criteria
  • Systemically healthy with no conditions known to affect periodontal healing or gingival response
  • Ability and willingness to attend all scheduled study visits at baseline, 1 month, 2 months, and 3 months
  • Willing and able to provide written informed consent

    -- Exclusion Criteria:

  • Uncontrolled diabetes mellitus
  • Use of interdental brushes within the previous 6 months
  • Current smoker or any tobacco user
  • Use of systemic antibiotics or anti-inflammatory medications within the previous 3 months
  • Regular use of anti-plaque or antimicrobial mouth rinses within the previous 3 months
  • Currently pregnant or breastfeeding
  • Fractured or defective fixed prosthesis requiring repair or replacement prior to enrollment
  • Inability to attend scheduled follow-up visits

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Touch-to-Teach Instruction
Participants received standardized oral hygiene instruction (Modified Bass technique) and full-mouth scaling and root surface debridement, plus individualized Touch-to-Teach interdental brush instruction using the Curaprox Chairside System. A color-coded CPS colorimetric probe measured each interproximal space precisely (blue 0.6mm, red 0.7mm, pink 0.8mm, yellow 0.9mm, green 1.1mm). Matching color-coded brushes were prescribed per site. The clinician demonstrated correct technique on a dental model then guided each patient through the procedure in their own mouth until correct insertion, manipulation, and removal were demonstrated at each designated space. Prescribed size-calibrated interdental brushes were provided for home use throughout the 3-month study period

Individualized interdental brush care delivered using the Curaprox Chairside System (Curaprox AG) through three structured phases:

Diagnostic Phase: CPS colorimetric probe with five autoclavable color-coded tips (blue 0.6mm, red 0.7mm, pink 0.8mm, yellow 0.9mm, green 1.1mm) used to measure precise accessibility diameter of each interproximal space.

Prescription Phase: Matching color-coded interdental brush selected per space. Brush correctly sized when fitting snugly without wire bending or forceful insertion required.

Training Phase: Clinician demonstrated technique on dental model then guided patient through procedure in their own mouth until proficiency in correct insertion angle, gentle manipulation, and removal was achieved at each space. Prescribed brushes provided for daily home use for 3 months.

Comparatore attivo: Conventional Instruction (Active Comparator)
Participants received standardized oral hygiene instruction (Modified Bass technique) and full-mouth scaling and root surface debridement. Conventional guidance comprised verbal instruction, access to European Federation of Periodontology animated patient education videos on interdental cleaning, and chairside hands-on demonstration of interdental brush insertion and manipulation using dental models with error correction. Brush size was selected empirically by the clinician without a calibrated sizing system. No personalized brush prescription, no CPS probe measurement, and no in-mouth guided insertion were provided.
Standardized oral hygiene guidance comprising: verbal instruction in Modified Bass toothbrushing technique; access to European Federation of Periodontology patient portal animated education videos demonstrating interdental cleaning techniques; and chairside hands-on demonstration of interdental brush insertion and manipulation using dental models with corrections provided as necessary. Brush size selected empirically without calibrated probe system. No personalized brush prescription, no CPS probe measurement, and no in-mouth guided insertion performed.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gingival Index (GI)
Lasso di tempo: Baseline, 1, 2, and 3 months (primary endpoint: 3 months)
Description: Full-mouth Gingival Index (Löe & Silness, 1963) assessed at crown-adjacent interproximal sites on a 0-3 ordinal scale: 0 = normal gingiva; 1 = mild inflammation, no bleeding on probing; 2 = moderate inflammation with bleeding on probing; 3 = severe inflammation with spontaneous bleeding tendency.
Baseline, 1, 2, and 3 months (primary endpoint: 3 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bleeding on Probing (BOP%)
Lasso di tempo: Baseline, 1 month, 2 months, and 3 months
Presence or absence of bleeding within 10 seconds of gentle probing of the sulcus or pocket recorded at 6 sites per tooth using a UNC-15 periodontal probe. Expressed as percentage of bleeding-positive sites out of total sites examined. Clinical indicator of gingival inflammation and tissue response to each instructional method. Assessed by blinded examiner
Baseline, 1 month, 2 months, and 3 months
Patient-reported acceptability (PROM)
Lasso di tempo: 3 months
Five-item questionnaire assessing: acceptability of interdental brush use, discomfort during use, willingness to recommend interdental brushes to others, perceived plaque removal efficacy, and self-reported regularity of use. Each item scored on a five-point Likert scale (1 = most negative response to 5 = most positive response); total scores range from 5 to 25, with higher scores indicating greater acceptability of the Touch-to-Teach instructional method. Reported as exploratory.
3 months
Plaque Index (PI)
Lasso di tempo: Baseline, 1 month, 2 months, and 3 months
Full-mouth plaque assessed using O'Leary Plaque Control Record at 6 sites per tooth (mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, distolingual) by running a UNC-15 periodontal probe along the gingival margin. Presence of plaque scored as 1, absence as 0. Reflects degree of interproximal plaque control achieved by each instructional method. Assessed by blinded examiner.
Baseline, 1 month, 2 months, and 3 months
Probing Pocket Depth (PD)
Lasso di tempo: Baseline, 1 month, 2 months, and 3 months
Plaque accumulation recorded at crown-adjacent sites using the Plaque Index of Silness and Löe, applied without a disclosing agent, on a 0-3 ordinal scale: 0 = no plaque detectable by visual inspection or probe; 1 = no plaque visible to the naked eye but detectable by running the probe tip along the gingival margin; 2 = a moderate layer of plaque visible at the gingival margin; 3 = abundant soft deposits filling the gingival crevice. Higher scores indicate greater plaque accumulation. Assessed by a blinded examiner.
Baseline, 1 month, 2 months, and 3 months
Patient-Reported Outcome Measures (PROMs)
Lasso di tempo: 1 month and 3 months
Two-part structured questionnaire. At baseline, a three-item screen assessed prior awareness of interdental cleaning aids and current oral hygiene practices. At one and three months, acceptability was assessed across four domains: comfort during interdental brush use, ease of use, perceived oral cleanliness, and overall satisfaction. Each item scored on a five-point Likert scale (1 = most negative to 5 = most positive); total scores range from 4 to 20, with higher scores indicating greater patient acceptability of the Touch-to-Teach instructional method. Reported as exploratory. Assessed by a blinded examiner.
1 month and 3 months

Collaboratori e investigatori

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Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

15 marzo 2024

Completamento primario (Effettivo)

15 giugno 2025

Completamento dello studio (Effettivo)

15 giugno 2025

Date di iscrizione allo studio

Primo inviato

20 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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