Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
NCT ID: NCT07309653
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
23 participants
OBSERVATIONAL
2025-12-16
2027-10-28
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Test
Restoring with an injectable single shade composite resin using an injectable moulding technique
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
15 Years
ALL
Yes
Sponsors
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Mahidol University
OTHER
Responsible Party
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Sawanya Prutthithaworn
Principal Investigator
Principal Investigators
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Pipop Saikaew, PhD
Role: STUDY_DIRECTOR
Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University
Locations
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Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MU-DT/PY-IRB 2025/082.3010
Identifier Type: -
Identifier Source: org_study_id
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