Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tooth Injuries, Dental Restoration, Permanent. Basic parameters: 6 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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?
Primary outcome measures
- Colour matching [Time frame: Immediate, 1-week, 6-month, 12-month after restoration]
- Colour stability [Time frame: 1-week, 6-month, 12-month after restoration]
Secondary outcome measures (2)
- Patient satisfaction [Time frame: 1-week, 6-month, 12-month after restoration]
- Parent satisfaction [Time frame: 1-week, 6-month, 12-month after 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Thailand · 1 center
- Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University — Bangkok
Identifiers
NCT: NCT07309653 · MU-DT/PY-IRB 2025/082.3010