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

Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation

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?

Study Overview

• Status: Recruiting
• Conditions: Tooth Injuries; Dental Restoration, Permanent

• Study Type: Observational
• Enrollment (Estimated): 23

Contacts and Locations

• Study Contact: Name: Sawanya Prutthithaworn Dr, PhD; Phone Number: +662-200-7821; Email: sawanya.pru@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University
    • Contact: Sawanya Prutthithaworn, Dr; Phone Number: +662-200-7821; Email: sawanya.pru@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Test; Restoring with an injectable single shade composite resin using an injectable moulding technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patients show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).	1-week, 6-month, 12-month after restoration
Parent satisfaction	Parents show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).	1-week, 6-month, 12-month after restoration

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Study Director: Pipop Saikaew, PhD, Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): October 29, 2026
• Study Completion (Estimated): October 28, 2027

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Estimated): December 30, 2025

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Patient satisfaction; Dental trauma; Color stability; Color matching; Single shade composter resins; Injection moulding technique; Flowable composite resins
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Wounds and Injuries; Tooth Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Tooth Injuries; Patient Satisfaction
• Other Study ID Numbers: MU-DT/PY-IRB 2025/082.3010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No