Touch-to-Teach Interdental Brush Instruction Versus Conventional Guidance on Gingival Health in Patients With Fixed Dental Prostheses
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.
연구 개요
상태
정황
상세 설명
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
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ajman Emirate
-
Ajman, Ajman Emirate, 아랍 에미리트
- ostgraduate Dental Center, Thumbay University Hospital, Gulf Medical University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gingival Index (GI)
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Bleeding on Probing (BOP%)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .