Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth

NCT07309653 | Recruiting

• 1 other identifier: MU-DT/PY-IRB 2025/082.3010
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the clinical performance of a single-shade composite resin, used with an injection moulding technique, in restoring maxillary incisors affected by traumatic dental injury in patients aged 6-15 years. The main questions it aims to answer are:

• How well does a single composite resin colour match the natural tooth?
• How stable is the colour over a 6- and 12-month follow-up?
• How satisfied are the children and parents with the restoration?

Conditions

Tooth Injuries; Dental Restoration, Permanent

Keywords

Patient satisfaction; Color stability; Color matching; Single shade composter resins; Injection moulding technique; Flowable composite resins; Dental trauma

Outcome Measures

Primary Outcomes (2)

• Colour matching

  Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency.

  Immediate, 1-week, 6-month, 12-month after restoration

• Colour stability

  Colour match and translucency, surface and margin staining, and surface lustre grading of 'very good' according to FDI criteria indicates clinically excellent colour stability.

  1-week, 6-month, 12-month after restoration

Secondary Outcomes (2)

• Patient satisfaction

  1-week, 6-month, 12-month after restoration

• Parent satisfaction

  1-week, 6-month, 12-month after restoration

Study Arms (1)

Test

Restoring with an injectable single shade composite resin using an injectable moulding technique

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 6-15 years who visit the Pediatric Dental Clinic at the Faculty of Dentistry, Mahidol University, for maxillary anterior tooth restoration

You may qualify if:

• Children who exhibit cooperative dental behaviours (rating 3 and 4) according to Frankl's behaviour rating scale (Frankl et al. 1962)
• Presence of at least one maxillary anterior permanent tooth with one-third of crown structure loss from dental trauma
• The affected tooth must be vital or have undergone vital pulp therapy (e.g., pulpotomy with Calcium hydroxide, white-MTA, or Biodentine)

You may not qualify if:

• Known allergy to methacrylate-based materials
• Presence of parafunctional habits, such as bruxism
• Presence of rampant caries
• Presence of signs of hypomineralisation, such as post-eruptive breakdown, hypersensitivity, changes in enamel texture and hardness, and abnormal translucency on radiographs.
• The affected tooth is classified as having moderate or severe discolouration according to Dean's fluorosis index (Dean, 1942)
• The affected tooth has lost less than one-third of its coronal crown structure
• The affected tooth has a fracture located at the subgingival margin
• The affected tooth requires splinting due to the severity of the trauma
• Presence of severe malocclusion that could compromise the integrity of the restoration

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University

Bangkok, Thailand

RECRUITING

MeSH Terms

Conditions

Tooth Injuries; Patient Satisfaction

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Pipop Saikaew, PhD

  Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University

  STUDY DIRECTOR

Central Study Contacts

Sawanya Prutthithaworn Dr, PhD

CONTACT

+662-200-7821; sawanya.pru@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): October 29, 2026
• Study Completion (Estimated): October 28, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)