AzTrials
AzTrials

Dental Plaque AccumulationNCT07421687

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

An observational study of Dental Plaque Accumulation and Oral Hygiene, Oral Health, run by Trakya University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Intraoral scanning (TRIOS 3) with plaque disclosure assessment and Conventional plaque scoring (TMQHPI) after plaque disclosure
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2027to 1 Jan 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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. 
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ece Açıkgöz Alparslan Principal Investigator contact

+902842364552

eceacikgoz@trakya.edu.tr

Turkey (Türkiye)1 site
  • Trakya University

    Merkez, Edirne, +902842564552

    Principal Investigator, +902842564552, eceacikgoz@trakya.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: Differences in Plaque Accumulation on Natural Teeth, Composite Restorations, and Ceramic Veneers Assessed by Intraoral Scanner-Based 3D Volumetric Analysis

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?
Read more

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.
Read the detailed description

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:

  1. Natural tooth surfaces without restorations,
  2. Direct composite restorations, or
  3. Indirect ceramic veneer restorations. All groups will undergo the same standardized assessment workflow on day four. 

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:

  1. Baseline IOS scanning and standardized photographs after the 4-day plaque accumulation period;
  2. Application of a plaque-disclosing procedure as used in routine care, followed by repeat IOS scanning/photographs and conventional clinical plaque scoring by a calibrated periodontist; and
  3. A supervised 2-minute toothbrushing session using the modified Bass technique with a manual toothbrush and fluoride toothpaste, followed by final IOS scanning and photographs to document post-brushing changes. If residual disclosed plaque remains after supervised brushing, it will be removed professionally (e.g., with brush and floss) before the participant returns to their usual oral-hygiene routine, and the study procedures will end at that visit.  

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.

Being tested
Intraoral scanning (TRIOS 3) with plaque disclosure assessment, Conventional plaque scoring (TMQHPI) after plaque disclosure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoral scanning (TRIOS 3) with plaque disclosure assessmentDiagnostic 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.

  • Conventional plaque scoring (TMQHPI) after plaque disclosureDiagnostic test

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

Study groups in NCT07421687
Study groupRoleWhat they receive
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).
Receives: Diagnostic Test: Intraoral scanning (TRIOS 3) with plaque disclosure assessment; Diagnostic Test: Conventional plaque scoring (TMQHPI) after plaque disclosure
Composite RestorationParticipants 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).
Receives: Diagnostic Test: Intraoral scanning (TRIOS 3) with plaque disclosure assessment; Diagnostic Test: Conventional plaque scoring (TMQHPI) after plaque disclosure
Indirect Ceramic Veneer RestorationParticipants 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).
Receives: Diagnostic Test: Intraoral scanning (TRIOS 3) with plaque disclosure assessment; Diagnostic Test: Conventional plaque scoring (TMQHPI) after plaque disclosure

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. 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)

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

  2. 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.

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

  3. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start1 Jan 2027 (estimated)
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07421687
Sponsor's protocol ID
TRIOS3MDP
Status last verified
Sep 2026
First submitted
12 Feb 2026
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Plaque Accumulation and Oral Hygiene, Oral Health, run by Trakya University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ece Açıkgöz Alparslan Principal Investigator (+902842364552, eceacikgoz@trakya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement Between Intraoral Scanner-Derived Plaque-Covered Surface Measures and TMQHPI Scores After Plaque Disclosure (time frame: Day 4 (after 4-day plaque accumulation), after plaque disclosure (same visit).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in