An observational study in Dental Plaque Accumulation, Oral Hygiene, Oral Health and Dental Materials, sponsored by Trakya University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Trakya University · Observational
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:
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:
This is an observational, parallel-group study conducted at the Trakya University Faculty of Dentistry, Department of Periodontology, designed to compare a three-dimensional (3D) intraoral scanner (IOS)-based, computer-assisted approach for mapping and quantifying dental biofilm on tooth and restoration surfaces with a conventional clinical plaque scoring approach used in routine practice.  
Participants will be recruited from individuals attending the periodontology clinic who receive routine non-surgical periodontal care, including professional mechanical plaque removal (PMPR) and a standard motivational oral-hygiene session as part of usual clinical management. Following PMPR at the initial visit, eligible and consenting participants will be asked to refrain from mechanical and/or chemical plaque-control procedures for four days while maintaining their usual diet, to allow development of a mature dental biofilm for standardized assessment.  
Participants will be allocated into three groups based on the presence and type of maxillary anterior vestibular surface condition:
On day 4, whole-arch intraoral scans will be obtained using the TRIOS 3 IOS® (3Shape, Copenhagen, Denmark) following a standardized scanning strategy to capture 3D models of the dental arches (with emphasis on vestibular surfaces) and to enable digital archiving and subsequent analysis. The TRIOS 3® is a non-invasive optical device that generates a 3D surface model by processing sequential images into a point cloud and triangulated mesh; scanning does not require local anesthesia and does not involve ionizing radiation. Standardized intraoral photographs of vestibular surfaces will also be recorded at each stage for documentation and cross-referencing.  
The assessment visit includes three sequential stages:
The IOS-derived 3D datasets will be used to compute quantitative plaque-related measures from the digital models and to generate 3D visual maps highlighting areas of plaque retention across the dental arch. These digital outputs will be compared with the conventional clinical plaque scoring approach to evaluate concordance and the ability to capture change after supervised brushing, and to explore potential differences in plaque accumulation patterns between natural tooth surfaces and restorative material surfaces.  
A total sample of 45 participants (approximately equally distributed across the three groups) is planned, based on an a priori power calculation with allowance for potential loss. Overall study conduct includes recruitment and assessments, followed by data organization and statistical analyses within the planned study period.
Trakya University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from adults attending the Periodontology Department clinic at Trakya University Faculty of Dentistry (Edirne, Türkiye) for routine dental/periodontal care and professional plaque control. The source population consists of generally healthy dental patients from this outpatient clinic setting who have maxillary anterior vestibular surfaces that can be categorized by existing surface condition/restoration status for observational comparison
Exclusion Criteria:
Participants with intact maxillary anterior vestibular surfaces without direct or indirect restorations. Plaque accumulation and removal will be assessed on natural tooth surfaces using the study's standardized workflow (intraoral scanning and conventional plaque scoring after plaque disclosure, and after supervised toothbrushing).
Diagnostic Test: Intraoral scanning (TRIOS 3) with plaque disclosure assessment · Diagnostic Test: Conventional plaque scoring (TMQHPI) after plaque disclosure
Participants presenting maxillary anterior vestibular composite restorations. Plaque accumulation and removal will be assessed on the restored surfaces using the same standardized workflow as other groups (intraoral scanning and conventional plaque scoring after plaque disclosure, and after supervised toothbrushing).
Diagnostic Test: Intraoral scanning (TRIOS 3) with plaque disclosure assessment · Diagnostic Test: Conventional plaque scoring (TMQHPI) after plaque disclosure
Participants presenting maxillary anterior vestibular indirect ceramic veneer restorations. Plaque accumulation and removal will be assessed on the veneer surfaces using the same standardized workflow as other groups (intraoral scanning and conventional plaque scoring after plaque disclosure, and after supervised toothbrushing).
Diagnostic Test: Intraoral scanning (TRIOS 3) with plaque disclosure assessment · Diagnostic Test: Conventional plaque scoring (TMQHPI) after plaque disclosure
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.
Clinical plaque assessment using the Turesky modified Quigley-Hein Plaque Index performed after plaque disclosure by a calibrated examiner.
Agreement Between Intraoral Scanner-Derived Plaque-Covered Surface Measures and TMQHPI Scores After Plaque Disclosure
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.
Time frame: Day 4 (after 4-day plaque accumulation), after plaque disclosure (same visit).
Difference Between Surface Types in Plaque Retention
Comparison across predefined surface-type groups (natural tooth surfaces without restorations vs direct composite restorations vs indirect ceramic veneer restorations) in: plaque retention after a 4-day plaque accumulation period (plaque-covered surface measurement after plaque disclosure)
Time frame: Day 4 (after 4-day plaque accumulation), after plaque disclosure (same visit)
Change From Pre-Brushing to Post-Brushing in Intraoral Scanner-Derived Plaque-Covered Surface Measurements Across Surface Types
Plaque removal effectiveness was quantified as the within-participant change in plaque-covered surface measurements derived from TRIOS 3® intraoral scans obtained immediately before and immediately after supervised 2-minute toothbrushing (modified Bass technique) on Day 4, compared across the three surface-type groups.
Time frame: Day 4, pre-brushing and immediately post-brushing (same visit).
Change From Pre-Brushing to Post-Brushing in TMQHPI Scores Across Surface Types
Plaque removal effectiveness was quantified as a within-participant change in clinical plaque scores assessed using the Turesky modified Quigley-Hein Plaque Index (TMQHPI) immediately before and immediately after supervised 2-minute toothbrushing (modified Bass technique) on Day 4, compared across the three surface-type groups (natural tooth surfaces vs direct composite vs indirect ceramic veneers).
Time frame: Day 4, pre-brushing and immediately post-brushing (same visit).
Plan to share: No — Individual participant data (IPD) and data dictionaries will not be made publicly available. The study dataset contains potentially identifiable clinical and imaging-derived information. Only aggregate, de-identified results will be reported in publications and presentations. Access to additional information may be considered on a case-by-case basis upon reasonable request and subject to institutional approvals and applicable regulations.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Trakya University