NCT07636954

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

May 20, 2026

Last Update Submit

June 7, 2026

Conditions

Keywords

Touch-to-Teachinterdental brushfixed prosthesisgingival healthplaque controlpatient educationoral hygiene instructionperiodontal maintenance

Outcome Measures

Primary Outcomes (1)

  • Gingival Index (GI)

    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)

Secondary Outcomes (5)

  • Bleeding on Probing (BOP%)

    Baseline, 1 month, 2 months, and 3 months

  • Patient-reported acceptability (PROM)

    3 months

  • Plaque Index (PI)

    Baseline, 1 month, 2 months, and 3 months

  • Probing Pocket Depth (PD)

    Baseline, 1 month, 2 months, and 3 months

  • Patient-Reported Outcome Measures (PROMs)

    1 month and 3 months

Study Arms (2)

Touch-to-Teach Instruction

EXPERIMENTAL

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

Behavioral: Touch-to-Teach interdental brush instruction

Conventional Instruction (Active Comparator)

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.

Behavioral: Conventional oral hygiene instruction

Interventions

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.

Touch-to-Teach Instruction

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.

Conventional Instruction (Active Comparator)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ostgraduate Dental Center, Thumbay University Hospital, Gulf Medical University

Ajman, Ajman Emirate, United Arab Emirates

Location

Related Publications (13)

  • Listgarten MA. The role of dental plaque in gingivitis and periodontitis. J Clin Periodontol. 1988 Sep;15(8):485-7. doi: 10.1111/j.1600-051x.1988.tb01019.x.

    PMID: 3053789BACKGROUND
  • Rosenauer T, Wagenschwanz C, Kuhn M, Kensche A, Stiehl S, Hannig C. The Bleeding on Brushing Index: a novel index in preventive dentistry. Int Dent J. 2017 Oct;67(5):299-307. doi: 10.1111/idj.12300. Epub 2017 May 15.

    PMID: 28503739BACKGROUND
  • Carrouel F, Llodra JC, Viennot S, Santamaria J, Bravo M, Bourgeois D. Access to Interdental Brushing in Periodontal Healthy Young Adults: A Cross-Sectional Study. PLoS One. 2016 May 18;11(5):e0155467. doi: 10.1371/journal.pone.0155467. eCollection 2016.

    PMID: 27192409BACKGROUND
  • Slot DE, Wiggelinkhuizen L, Rosema NA, Van der Weijden GA. The efficacy of manual toothbrushes following a brushing exercise: a systematic review. Int J Dent Hyg. 2012 Aug;10(3):187-97. doi: 10.1111/j.1601-5037.2012.00557.x. Epub 2012 Jun 6.

    PMID: 22672101BACKGROUND
  • Claydon NC. Current concepts in toothbrushing and interdental cleaning. Periodontol 2000. 2008;48:10-22. doi: 10.1111/j.1600-0757.2008.00273.x. No abstract available.

    PMID: 18715352BACKGROUND
  • O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

    PMID: 4500182BACKGROUND
  • 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: 27681016BACKGROUND
  • Slot DE, Dorfer CE, Van der Weijden GA. The efficacy of interdental brushes on plaque and parameters of periodontal inflammation: a systematic review. Int J Dent Hyg. 2008 Nov;6(4):253-64. doi: 10.1111/j.1601-5037.2008.00330.x.

    PMID: 19138177BACKGROUND
  • Worthington HV, MacDonald L, Poklepovic Pericic T, Sambunjak D, Johnson TM, Imai P, Clarkson JE. Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries. Cochrane Database Syst Rev. 2019 Apr 10;4(4):CD012018. doi: 10.1002/14651858.CD012018.pub2.

    PMID: 30968949BACKGROUND
  • Ng E, Lim LP. An Overview of Different Interdental Cleaning Aids and Their Effectiveness. Dent J (Basel). 2019 Jun 1;7(2):56. doi: 10.3390/dj7020056.

    PMID: 31159354BACKGROUND
  • Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

    PMID: 29926952BACKGROUND
  • Salzer S, Slot DE, Van der Weijden FA, Dorfer CE. Efficacy of inter-dental mechanical plaque control in managing gingivitis--a meta-review. J Clin Periodontol. 2015 Apr;42 Suppl 16:S92-105. doi: 10.1111/jcpe.12363.

    PMID: 25581718BACKGROUND
  • Subramanya AP, Prabhuji MLV. Comparative evaluation of efficacy and patient-reported outcome measures of oral hygiene instruction methods for calibrated interdental brush. Int J Dent Hyg. 2021 Aug;19(3):287-294. doi: 10.1111/idh.12530. Epub 2021 Jun 18.

Related Links

MeSH Terms

Conditions

GingivitisPeriodontal DiseasesDental Plaque

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesMouth DiseasesStomatognathic DiseasesDental DepositsTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blind study design. The clinical examiner performing periodontal measurements (PI, GI, PD, BOP) at baseline and follow-up visits was blinded to group allocation. Participants could not be blinded due to the distinct nature of Touch-to-Teach hands-on instruction versus conventional verbal guidance. The treating clinician delivering interventions was not blinded. Allocation concealment maintained using sequentially-numbered opaque envelopes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm parallel randomized controlled trial comparing Touch-to-Teach interdental brush instruction using the Curaprox Colorimetric Probe System (experimental arm) versus conventional oral hygiene instruction (active control arm) in patients with fixed dental prostheses. Both arms received baseline full-mouth scaling and standardized oral hygiene instruction. The experimental arm received additional individualized hands-on Touch-to-Teach interdental brush training with size-calibrated brush provision for 3 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

June 9, 2026

Study Start

March 15, 2024

Primary Completion

June 15, 2025

Study Completion

June 15, 2025

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations