- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07648979
3D-Printed Resin Crowns vs Stainless Steel Crowns in Pulpotomized Primary Molars. (3DRSCVSSSC)
Clinical Evaluation of 3D Printed Resin Based Crowns Versus Stainless Steel Crowns in Pulpotomized Primary Mandibular Molars : A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn whether 3D-printed resin-based crowns are an effective alternative to stainless steel crowns for restoring pulpotomized primary mandibular molars in children. The main questions it aims to answer are:
Do 3D-printed resin-based crowns provide better gingival health than stainless steel crowns? Are there differences in plaque accumulation, crown retention, and child and parent satisfaction between the two crown types?
Participants will:
Receive either a 3D-printed resin-based crown or a stainless steel crown after pulpotomy.
Attend follow-up visits for clinical evaluation over 12 months.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nariman Osama, BDS
- Numéro de téléphone: 01010381531
- E-mail: Nareman.osama@dentistry.cu.edu.eg
Lieux d'étude
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-
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Cairo, Egypte
- Faculty of Dentistry
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
Children aged 4 to 8 years. Cooperative children who are able to accept dental treatment. Teeth diagnosed with reversible pulpitis. Children in good general health with no systemic conditions affecting oral health.
Parents/guardians willing to provide written informed consent and attend follow-up visits.
Exclusion Criteria:
Teeth deemed non-restorable (e.g., gross carious destruction or fractures beyond restoration).
Parents/guardians unwilling to participate in the study or provide informed consent.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 3D printed resin crowns
Children will receive indirect restorations using 3D-printed resin crowns on primary molars affected by reversible pulpitis
|
1-Select an appropriately sized resin-based prefabricated crown based on the mesio-distal width of the tooth.
2-Perform occlusal reduction of approximately 1.5-2.0
mm following the natural occlusal anatomy.
3-Reduce buccal and lingual cusps, central groove, and marginal ridges to achieve adequate occlusal clearance.
4-Perform proximal reduction using a tapered fissure or diamond bur to eliminate mesial and distal contacts by approximately 1.0 mm.
5-Avoid creating ledges or damaging adjacent teeth during proximal reduction.
6-Slightly reduce buccal and lingual surfaces to eliminate undercuts and facilitate crown seating.
7-Round and smooth all sharp line angles and points of the preparation.
8-In cases with adjacent teeth, perform additional interproximal reduction if required for proper seating.9-Try-in the crown intraorally and seat it using firm pressure from lingual to buccal direction.
10-Check marginal adaptation, ensuring slight subgingival extension (approximately 0.5-1.0
mm).
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|
Comparateur actif: Stainless steel crowns
Children will receive stainless steel crowns on primary molars affected by reversible pulpitis
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1-Select an appropriately sized stainless steel crown based on the mesiodistal width of the tooth.
2-Perform minimal occlusal reduction (approximately 1.0-1.5 mm) following the anatomical occlusal contour to create suficient space for crown placement.
3-Lightly reduce proximal contacts to allow crown seating, without creating steps or excessive taper.
4-Perform minimal buccal and lingual reduction only if required to eliminate undercuts and facilitate passive seating.
5-Round sharp line angles and smooth rough surfaces to allow proper adaptation.
5-Verify adequate occlusal clearance and passive path of insertion.
6-Try-in the crown and adjustsize if necessary to ensure proper fit.
7-Trim and contour crown margins to achieve optimal gingival adaptation (if needed).
8-Seat the crown firmly using finger pressure to confirm complete seating.
9-Cement the crown with glass ionomer cement and remove excess cement after initial setting.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Gingival index
Délai: baseline, 3 months, 6 months, 9 months, 12 months
|
The GI was measured by passing an explorer tip gently within the sulcus mesial, distal, buccal, and lingual surface of each crowned molar. it was scored on a scale of 0 to 3 0= no bleeding
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baseline, 3 months, 6 months, 9 months, 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Plaque accumulation
Délai: baseline, 3 months, 6 months, 9 months, 12 months
|
Silness &Löe plaque index 0: no plaque.
1: film at gingival margin.
2: moderate accumulation.
3: abundance of plaque.
|
baseline, 3 months, 6 months, 9 months, 12 months
|
|
Child and parent satisfaction
Délai: Immediately post operative
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Child and parent satisfaction will be assessed using a structured questionnaire based on a Likert scale.
Participants (children and their parents/guardians) will rate their satisfaction with the treatment experience, comfort, aesthetics, and overall acceptance.
Responses will be recorded on a 5-point Likert scale ranging from "very dissatisfied" to "very satisfied."
The scores will be analyzed to compare satisfaction between study groups.
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Immediately post operative
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Crown retention
Délai: baseline, 3 months, 6 months, 9 months, 12 months
|
Using United States Public Health Service (USPHS) criteria Alpha : intact Bravo : chipped or loss of material Charlie : complete loss of crown
|
baseline, 3 months, 6 months, 9 months, 12 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Sherine Badr, PHD, Cairo University
- Chercheur principal: Nariman Osama, BDS, Cairo University
- Directeur d'études: Hanna Abdel Moneim, PHD, Cairo University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FDCU-2026-01
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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