Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth

Mahidol University

Status: Enrolling

Conditions: Tooth Injuries; Dental Restoration, Permanent

Study type: Observational

Funder types: Other

Identifiers

NCT07309653

MU-DT/PY-IRB 2025/082.3010

Details and patient eligibility

About

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?

Enrollment: 23 estimated patients

Sex: All

Ages: 6 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 1 patient group

Test

Description:

Restoring with an injectable single shade composite resin using an injectable moulding technique