Dental Restoration, Permanent, Tooth Injuries
Conditions
Keywords
Patient satisfaction, Color stability, Color matching, Single shade composter resins, Injection moulding technique, Flowable composite resins, Dental trauma
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 follow-up? * How satisfied are the children and parents with the restoration?
Interventions
None listed
Sponsors
Mahidol University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colour matching | Immediate, 1-week, 6-month, 12-month after restoration | Colour match and translucency grading of 'very good' according to FDI criteria indicates clinically excellent colour matching and translucency. |
| Colour stability | 1-week, 6-month, 12-month after restoration | Colour match and translucency, surface and margin staining, and surface lustre grading of 'very good' according to FDI criteria indicates clinically excellent colour stability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 1-week, 6-month, 12-month after restoration | 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). |
| Parent satisfaction | 1-week, 6-month, 12-month after restoration | 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). |
Countries
Thailand
Contacts
Primary ContactSawanya Prutthithaworn Dr, PhD
Outcome results
None listed