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Clinical Trial NCT07309653 for Tooth Injuries, Dental Restoration, Permanent is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth 23 Observational

Recruiting
Clinical Trial NCT07309653 is an observational study for Tooth Injuries, Dental Restoration, Permanent that is recruiting. It started on 16 December 2025 with plans to enroll 23 participants. Led by Mahidol University, it is expected to complete by 28 October 2027. The latest data from ClinicalTrials.gov was last updated on 2 January 2026.
Brief Summary

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 f...
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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

Conditions
Tooth InjuriesDental Restoration, Permanent
Other Study IDs
  • MU-DT/PY-IRB 2025/082.3010
NCT ID Number
NCT07309653
Start Date (Actual)
2025-12-16
Last Update Posted
2026-01-02
Completion Date (Estimated)
2027-10-28
Enrollment (Estimated)
23
Study Type
Observational
Status
Recruiting
Keywords
Patient satisfaction
Color stability
Color matching
Single shade composter resins
Injection moulding technique
Flowable composite resins
Dental trauma
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Test
Restoring with an injectable single shade composite resin using an injectable moulding technique
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Colour matching
Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency.
Immediate, 1-week, 6-month, 12-month after restoration
Colour stability
Colour match and translucency, surface and margin staining, and surface lustre grading of 'very good' according to FDI criteria indicates clinically excellent colour stability.
1-week, 6-month, 12-month after restoration
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Patient satisfaction
Patients show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).
1-week, 6-month, 12-month after restoration
Parent satisfaction
Parents show the highest aesthetic satisfaction if they score 5 on a 5-point Likert scale on the aesthetic questionnaire, ranging from 5 (most satisfied) to 1 (not satisfied).
1-week, 6-month, 12-month after restoration
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
6 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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)

  • 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
Mahidol University logoMahidol University
Study Responsible Party
Sawanya Prutthithaworn, Principal Investigator, Principal Investigator, Mahidol University
Study Central Contact
Contact: Sawanya Prutthithaworn Dr, PhD, +662-200-7821, [email protected]
1 Study Locations in 1 Countries
Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand
Sawanya Prutthithaworn, Dr, Contact, +662-200-7821, [email protected]
Recruiting