Trakya University
Merkez, Edirne, +902842564552, Turkey (Türkiye)
NCT Number: NCT07421687
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 opening soon.
Get Notified18 year and older
All sexes
Observational
Merkez, Edirne, +902842564552, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Day 4 (after 4-day plaque accumulation), after plaque disclosure (same visit)
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, pre-brushing and immediately post-brushing (same visit).
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).
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).
Contact information is provided by the study sponsor or research team.
Trakya University
Other
Differences in Plaque Accumulation on Natural Teeth, Composite Restorations, and Ceramic Veneers Assessed by Intraoral Scanner-Based 3D Volumetric Analysis
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