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

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

Recruiting
6-15 years
All
Phase N/A

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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?

Eligibility

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

Study details
    Tooth Injuries
    Dental Restoration
    Permanent

NCT07309653

Mahidol University

1 February 2026

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