RecruitingNCT07309653

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

Sponsor

Mahidol University

Enrollment

23 participants

Start Date

Dec 16, 2025

Study Type

OBSERVATIONAL

Conditions

Tooth Injuries Dental Restoration, Permanent

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?

Eligibility

Min Age: 6 YearsMax Age: 15 Years

Inclusion Criteria3

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 Criteria9

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

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