ostgraduate Dental Center, Thumbay University Hospital, Gulf Medical University
Ajman, Ajman Emirate, United Arab Emirates
NCT Number: NCT07636954
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ajman, Ajman Emirate, United Arab Emirates
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-- Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Gulf Medical University
Other
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
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