Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-15
SponsorMahidol University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial population
Patients aged 6-15 years who visit the Pediatric Dental Clinic at the Faculty of Dentistry, Mahidol University, for maxillary anterior tooth restoration
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
23 Participants
are grouped into 1 trial groupGroup A: Test
Trial outcomes
Primary outcomes
1
Colour matching
Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency.
Time frame
Immediate, 1-week, 6-month, 12-month after restoration2
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.
Time frame
1-week, 6-month, 12-month after restorationSecondary outcomes
1
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).
Time frame
1-week, 6-month, 12-month after restoration2
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).
Time frame
1-week, 6-month, 12-month after restorationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov