Actively Recruiting

Age: 6Years - 15Years
All Genders
Healthy Volunteers
NCT07309653

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

Led by Mahidol University · Updated on 2026-01-02

23

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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?

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 15Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University

Bangkok, Thailand

Actively Recruiting

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Research Team

S

Sawanya Prutthithaworn Dr, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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