Ireland
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Starting soon Observational

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

NCT07421687 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2027-01-01
Last updated
2026-10-02

Condition(s) studied

Dental Plaque AccumulationOral Hygiene, Oral HealthDental MaterialsDental Plaque Imaging MethodsDental Plaque Index

Investigational drug(s) / intervention(s)

Intraoral scanning (TRIOS 3) with plaque disclosure assessmentConventional plaque scoring (TMQHPI) after plaque disclosure

Intraoral scanning (TRIOS 3) with plaque disclosure assessment: Whole-arch intraoral scans were obtained with the TRIOS 3 intraoral scanner to generate 3D digital models for plaque/biofilm assessment. Scans are performed at standardized time points, including after plaque accumulation and after plaque disclosure, to document plaque distribution and enable computer-assisted quantification and 3D mapping.

Conventional plaque scoring (TMQHPI) after plaque disclosure: Clinical plaque assessment using the Turesky modified Quigley-Hein Plaque Index performed after plaque disclosure by a calibrated examiner.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 18 years or older.  * Able and willing to provide written informed consent.  * Generally healthy and not using regular systemic medications.  * Have at least 6 teeth in each quadrant of the mouth.  * Have low plaque levels at baseline (plaque index \<10%).  * Do not have periodontal pockets deeper than 4 mm.  * In the upper front teeth (maxillary anterior) on the outer (vestibular) surfaces, participants must fit one of these predefined surface types: Natural tooth surface (no restoration ), direct composite restoration, or Indirect ceramic veneer restoration.  * No cavitated tooth decay on the surfaces to be assessed and no obvious surface defects that would clearly increase plaque retention. Exclusion Criteria: * Diagnosis of gingivitis or periodontitis.  * Regular use of mouthwash as part of daily oral hygiene.  * Use of antibiotics within the last 6 months.  * Smoking.  * Pregnant or breastfeeding.  * Presence of dental implants or removable dentures.  * Any systemic disease or medical treatment that could affect oral health or healing (examples include diabetes, cancer, disorders affecting bone metabolism, immunosuppressive therapy, chemotherapy, radiotherapy, or other conditions/medications affecting wound healing).  * Having a pacemaker or an implantable defibrillator.  * History of allergy or intolerance to study-related materials (e.g., ingredients of the plaque-disclosing agent or the lip/cheek retractor material).  * Defective fillings/restorations on the assessed surfaces that could increase plaque retention.  * Malocclusion or spacing between teeth (diastema).  * Gum recession affecting more than one-third of the root length.  * Wearing fixed orthodontic appliances (braces).  * Any physical, mental, or psychiatric condition that could interfere with understanding the study or completing the procedures

Primary outcome measure(s)

  • Agreement Between Intraoral Scanner-Derived Plaque-Covered Surface Measures and TMQHPI Scores After Plaque Disclosure — Day 4 (after 4-day plaque accumulation), after plaque disclosure (same visit).
    Agreement/concordance between plaque-covered surface measurements obtained from TRIOS 3® intraoral scan-based 3D analysis after plaque disclosure and conventional clinical plaque scoring using the Turesky modified Quigley-Hein Plaque Index (TMQHPI) assessed by a calibrated examiner at the same visit.

Trial sites (1)

FacilityCityRegionStatus
Trakya University Merkez Edirne
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07421687 on ClinicalTrials.gov ↗ ← All trials in Turkey