Single-shade composite color match and satisfaction for injured upper front teeth
Official title: Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation
Run by Mahidol University · NCT07309653 · Data updated 2026-11-12
This study will try a single-shade composite filling applied with an injection-molding technique to repair injured upper front permanent teeth in children aged 6–15 and see if the color matches, stays stable over 6 and 12 months, and if children and parents are satisfied.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 15 Years |
| Sex | All |
| Enrollment | 23 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | October 29, 2026 |
| Study ends | October 28, 2027 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07309653 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–15 who are cooperative (Frankl behavior rating 3–4) with at least one maxillary permanent incisor that has lost about one-third of its crown from trauma and that is vital or has had vital pulp therapy are ideal candidates.
✕Probably not a fit
Children with known methacrylate allergy, parafunctional habits like bruxism, rampant caries, signs of enamel hypomineralization, severe tooth discoloration, teeth with less than one-third crown loss, or who are uncooperative are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study of a single-shade composite resin placed with an injection-molding technique to restore maxillary incisors that lost about one-third of the crown from trauma. Eligible teeth must be vital or have received vital pulp therapy, and children must show cooperative behavior. Outcomes include immediate color match, color stability at 6 and 12 months, and patient/parent satisfaction. The study collects clinical photographs and satisfaction ratings during in-person follow-up visits without randomization or experimental arms.
Why it matters
Potential benefit: If successful, this approach could simplify shade matching and provide a quicker, esthetic restoration option for children with traumatic front-tooth injuries.
How similar studies have gone: Similar single-shade composite approaches and injection-molding techniques have shown promising short-term color matching in laboratory and some clinical reports, but long-term, pediatric trauma-specific evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University
Bangkok, Thailand Recruiting
Study contacts
- Study coordinator: Sawanya Prutthithaworn Dr, PhD
- Email: sawanya.pru@mahidol.ac.th
- Phone: +662-200-7821
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.