GingivitisNCT07636954
Touch-to-Teach Interdental Brush Instruction Versus Conventional Guidance on Gingival Health in Patients With Fixed Dental Prostheses
A study testing Touch-to-Teach interdental brush instruction and Conventional oral hygiene instruction in people with Gingivitis and Periodontal Disease, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingivitis, Periodontal Disease, Fixed Dental Prosthesis
- What is being tested?
- Touch-to-Teach interdental brush instruction and Conventional oral hygiene instruction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Mar 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
ostgraduate Dental Center, Thumbay University Hospital, Gulf Medical University
Ajman, Ajman Emirate
About this study
Official title: 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.
Read more
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.
Read the detailed description
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
- Being tested
- Touch-to-Teach interdental brush instruction, Conventional oral hygiene instruction
- Keywords
- Touch-to-Teach, interdental brush, fixed prosthesis, gingival health, plaque control, patient education, oral hygiene instruction, periodontal maintenance
- Medical subject headings
- Gingivitis, Periodontal Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Touch-to-Teach interdental brush instructionBehavioural
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.
Conventional oral hygiene instructionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Conventional oral hygiene instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1, 2, and 3 months (primary endpoint: 3 months)
Secondary outcomes (5)
Bleeding on Probing (BOP%)
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
Measured: Baseline, 1 month, 2 months, and 3 months
Patient-reported acceptability (PROM)
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.
Measured: 3 months
Plaque Index (PI)
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.
Measured: Baseline, 1 month, 2 months, and 3 months
Probing Pocket Depth (PD)
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.
Measured: Baseline, 1 month, 2 months, and 3 months
Patient-Reported Outcome Measures (PROMs)
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.
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start15 Mar 2024
- Primary completion15 Jun 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636954
- Sponsor's protocol ID
- MDSPerio2023 - 1
- Status last verified
- Jun 2026
- First submitted
- 20 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3053789Rosenauer 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.
PubMed 28503739Carrouel 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.
PubMed 27192409Slot 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.
PubMed 22672101Claydon 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.
PubMed 18715352O'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.
PubMed 4500182Bourgeois 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.
PubMed 27681016Slot 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.
PubMed 19138177Worthington 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.
PubMed 30968949Ng 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.
PubMed 31159354Tonetti 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.
PubMed 29926952Salzer 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.
PubMed 25581718Subramanya 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.
PubMed 34101341
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07636954
- Acronym / sponsor ID
- MDSPerio2023 - 1
- Keywords
- Touch-to-Teach, interdental brush, fixed prosthesis, gingival health, plaque control, patient education, oral hygiene instruction, periodontal maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Touch-to-Teach Instruction | Experimental | Behavioral: Touch-to-Teach interdental brush instructionParticipants 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 |
| Conventional Instruction (Active Comparator) | Active comparator | Behavioral: Conventional oral hygiene instructionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Touch-to-Teach interdental brush instructionIndividualized 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. | Behavioural | Touch-to-Teach Instruction |
| Conventional oral hygiene instructionStandardized 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. | Behavioural | Conventional Instruction (Active Comparator) |
Primary outcome
Gingival Index (GI)
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.
5 secondary outcomes
Bleeding on Probing (BOP%)
Time frame: Baseline, 1 month, 2 months, and 3 months
Patient-reported acceptability (PROM)
Time frame: 3 months
Plaque Index (PI)
Time frame: Baseline, 1 month, 2 months, and 3 months
Probing Pocket Depth (PD)
Time frame: Baseline, 1 month, 2 months, and 3 months
Patient-Reported Outcome Measures (PROMs)
Time frame: 1 month and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Background: PubMed 3053789Listgarten 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.
- Background: PubMed 28503739Rosenauer 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.
- Background: PubMed 27192409Carrouel 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.
- Background: PubMed 22672101Slot 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.
- Background: PubMed 18715352Claydon 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.
- Background: PubMed 4500182O'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.
- Background: PubMed 27681016Bourgeois 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.
- Background: PubMed 19138177Slot 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.
- Background: PubMed 30968949Worthington 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.
- Background: PubMed 31159354Ng 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.
- Background: PubMed 29926952Tonetti 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.
- Background: PubMed 25581718Salzer 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.
- European Federation of Periodontology patient education portal. Videos from this site were used as the educational resource for control group participants on interdental cleaning technique.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Touch-to-Teach interdental brush instruction and Conventional oral hygiene instruction in people with Gingivitis and Periodontal Disease, run by Gulf Medical University at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (GI) (time frame: Baseline, 1, 2, and 3 months (primary endpoint: 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07636954, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.