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3D Volumetric Plaque Assessment on Teeth, Composite Restorations, and Ceramic Veneers Using an Intraoral Scanner

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Mar 16, 2027 → Dec 15, 2027
See other at-risk trials from Trakya University

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Mar 16, 2027 to Dec 15, 2027 Show 4 more changesShow less
    • Start date: Mar 16, 2026 to Jan 1, 2027
    • Study completion pushed from Mar 24, 2027 to Jan 1, 2028
    • Eligibility criteria expanded, about 22 words
    • Study description expanded, about 6 words
  2. Minor Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description shortened, about 6 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to evaluate and compare a 3D intraoral scanner-based, computer-assisted approach for assessing dental biofilm/plaque accumulation on natural teeth and restorative surfaces with a conventional clinical plaque index (Turesky modified Quigley-Hein Plaque Index, TMQHPI) in systemically healthy adults. The main questions it aims to answer are: * How well does the plaque-covered surface measurement derived from 3D intraoral scanner data agree with TMQHPI scores after plaque disclosure? * How sensitively do the two methods detect changes in plaque levels after supervised toothbrushing? * Do plaque accumulation patterns differ between natural tooth surfaces and restorative materials (direct composite restorations and indirect ceramic veneers), and where are plaque-retentive areas most frequently located? Participants (≥18 years) will receive routine professional mechanical plaque removal as part of standard clinical care. They will then be asked to avoid mechanical and/or chemical plaque control for 4 days. At the follow-up visit, participants will undergo: 1. An intraoral scan and standardized photographs of the full dental arch, 2. Plaque disclosure followed by repeat scanning/photography and TMQHPI scoring by a periodontist, 3. Supervised toothbrushing using the modified Bass technique for 2 minutes, followed by a final scan and photographs. Digital models will be used to quantify plaque-covered surface measures and to generate 3D maps of plaque-retentive areas.
Trial Details
NCT Number NCT07421687
Lead Sponsor Trakya University
Conditions
(from sponsor)
Dental Plaque Accumulation, Oral Hygiene, Oral Health, Dental Materials, Dental Plaque Imaging Methods, Dental Plaque Index
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov