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L'essai clinique NCT07309653 pour Tooth Injuries, Dental Restoration, Permanent est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Université MahidolColour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth 23 Observationnel
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L'essai clinique NCT07309653 est une étude observationnel pour Tooth Injuries, Dental Restoration, Permanent. Son statut actuel est : en recrutement. L'étude a débuté le 16 décembre 2025 et vise à recruter 23 participants. Dirigée par l'Université Mahidol, l'étude devrait être terminée d'ici le 28 octobre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 janvier 2026.
Résumé succinct
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...
Titre officiel
Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation
Pathologies
Tooth InjuriesDental Restoration, PermanentAutres identifiants de l'étude
- MU-DT/PY-IRB 2025/082.3010
Numéro NCT
Date de début (réel)
2025-12-16
Dernière mise à jour publiée
2026-01-02
Date de fin (estimée)
2027-10-28
Inscription (estimée)
23
Type d'étude
Observationnel
Statut
En recrutement
Mots clés
Patient satisfaction
Color stability
Color matching
Single shade composter resins
Injection moulding technique
Flowable composite resins
Dental trauma
Color stability
Color matching
Single shade composter resins
Injection moulding technique
Flowable composite resins
Dental trauma
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Test Restoring with an injectable single shade composite resin using an injectable moulding technique | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant
Âge minimum
6 Years
Sexes éligibles
Tous
Accepte les volontaires en bonne santé
Oui
- 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
Université MahidolPartie responsable de l'étude
Sawanya Prutthithaworn, Investigateur principal, Principal Investigator, Mahidol University
Contact central de l'étude
Contact: Sawanya Prutthithaworn Dr, PhD, +662-200-7821, [email protected]
1 Centres de l'étude dans 1 pays
Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand
Sawanya Prutthithaworn, Dr, Contact, +662-200-7821, [email protected]
En recrutement