NCT07309653 Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
| NCT ID | NCT07309653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Tooth Injuries |
| Study Type | OBSERVATIONAL |
| Enrollment | 23 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2026-10-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 23 participants in total. It began in 2025-12-16 with a primary completion date of 2026-10-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Pipop Saikaew, PhD
STUDY DIRECTOR
Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University
Frequently Asked Questions
Who can join the NCT07309653 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 15 Years, studying Tooth Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309653 currently recruiting?
Yes, NCT07309653 is actively recruiting participants. Contact the research team at sawanya.pru@mahidol.ac.th for enrollment information.
Where is the NCT07309653 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT07309653 clinical trial?
NCT07309653 is sponsored by Mahidol University. The principal investigator is Pipop Saikaew, PhD at Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University. The trial plans to enroll 23 participants.