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

NCT07421687 | Not Yet Recruiting

• 1 other identifier: TRIOS3MDP
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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:
• An intraoral scan and standardized photographs of the full dental arch,
• Plaque disclosure followed by repeat scanning/photography and TMQHPI scoring by a periodontist,
• 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.

Conditions

Dental Plaque Accumulation; Oral Hygiene, Oral Health; Dental Materials; Dental Plaque Imaging Methods; Dental Plaque Index

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 4 (after 4-day plaque accumulation), after plaque disclosure (same visit).

Secondary Outcomes (3)

• Difference Between Surface Types in Plaque Retention

  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

  Day 4, pre-brushing and immediately post-brushing (same visit).

• Change From Pre-Brushing to Post-Brushing in TMQHPI Scores Across Surface Types

  Day 4, pre-brushing and immediately post-brushing (same visit).

Study Arms (3)

Natural Tooth Surfaces (No Restoration)

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

Composite Restoration

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

Indirect Ceramic Veneer Restoration

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

Interventions

Intraoral scanning (TRIOS 3) with plaque disclosure assessment DIAGNOSTIC_TEST

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.

Composite Restoration; Indirect Ceramic Veneer Restoration; Natural Tooth Surfaces (No Restoration)

Conventional plaque scoring (TMQHPI) after plaque disclosure DIAGNOSTIC_TEST

Clinical plaque assessment using the Turesky modified Quigley-Hein Plaque Index performed after plaque disclosure by a calibrated examiner.

Composite Restoration; Indirect Ceramic Veneer Restoration; Natural Tooth Surfaces (No Restoration)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Merkez, Edirne, +902842564552, Turkey (Türkiye)

Location

Study Officials

• Ece Açıkgöz Alparslan

  Trakya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ece Açıkgöz Alparslan Principal Investigator

CONTACT

+902842364552; eceacikgoz@trakya.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 16, 2027
• Study Completion (Estimated): March 24, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)