Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth (NCT07309653) | Clinical Trial Compass
RecruitingNot Applicable
Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
Thailand23 participantsStarted 2025-12-16
Plain-language 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?
Who can participate
Age range
6 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Colour matching
Timeframe: Immediate, 1-week, 6-month, 12-month after restoration
2
Colour stability
Timeframe: 1-week, 6-month, 12-month after restoration