Actively Recruiting
Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation
Led by Mahidol University · Updated on 2026-01-02
23
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance of a single-shade composite resin, applied with an injection moulding technique, to restore maxillary incisors damaged by traumatic dental injury in children aged 6 to 15 years. The study aims to answer how well the composite resin matches the natural tooth color, how stable this color remains over 6 and 12 months, and how satisfied the children and their parents are with the restoration. The study involves restoring the affected anterior teeth using an injectable single-shade composite resin through a silicone-guided index technique. There are no comparison groups mentioned, as this is an observational study focusing on one treatment method. Assessments will occur immediately, at 1 week, 6 months, and 12 months after restoration to evaluate color matching, color stability, and patient and parent satisfaction. Participants will be monitored over a 12-month period with evaluations at multiple intervals post-restoration. These include color matching and stability assessments as primary outcomes and satisfaction surveys from both patients and parents as secondary outcomes. The study will track dental health and restoration performance without altering standard care, ensuring a detailed understanding of the composite resin's clinical use and patient experience.
CONDITIONS
Brief 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 show cooperative dental behavior (rating 3 or 4) based on Frankl's behavior scale
- At least one upper front permanent tooth with loss of one-third of the crown due to dental trauma
- The affected tooth is alive or has had vital pulp therapy such as pulpotomy with Calcium hydroxide, white-MTA, or Biodentine
You will not qualify if you...
- Known allergy to methacrylate-based dental materials
- Habits like teeth grinding (bruxism)
- Presence of widespread tooth decay (rampant caries)
- Signs of hypomineralisation like enamel breakdown, sensitivity, texture changes, or abnormal translucency on X-rays
- Tooth discoloration classified as moderate or severe by Dean's fluorosis index
- Tooth has lost less than one-third of its crown
- Tooth fracture located below the gum line (subgingival margin)
- Tooth needs splinting due to severe trauma
- Severe misalignment of teeth that affects restoration integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Immediate
Participants receive restoration with an injectable single shade composite resin using an injectable moulding technique on a maxillary anterior tooth.
1 visit (in-person)
Duration - 12 months
Participants are monitored for colour matching, colour stability, and satisfaction of the restoration over time.
Visits at 1 week, 6 months, and 12 months after restoration
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
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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