Actively Recruiting
Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
Led by Mahidol University · Updated on 2026-01-02
23
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University
Bangkok, Thailand
Actively Recruiting
Research Team
S
Sawanya Prutthithaworn Dr, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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