- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03770871
Indirect Pulp Treatment in Primary Molars (RCT)
Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
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Cairo, Egypte, 11553
- Faculty of Oral and Dental Medicine
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria:
In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"
In addition to:
I-Subjects:
- Medically free children, their parent(s) accepts to sign the informed consent.
- Age range from 4-8 years.
II-Molars:
- Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
- Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
- Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).
Exclusion criteria:
I-Subjects:
- Uncooperative children.
- Parents unable to attend follow up visits (even after explaining the importance of recall visits).
II-Molars:
- History of spontaneous pain (to exclude reversible pulpitis).
- Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
- Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: IPT using Dycal (TM )
Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
|
Partial caries removal and protection of the dental pulp with biocompatible material
Autres noms:
Partial caries removal and protection of the dental pulp with biocompatible material
Autres noms:
|
|
Expérimental: IPT using Vitrebond (TM )
Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
|
Partial caries removal and protection of the dental pulp with biocompatible material
Autres noms:
Partial caries removal and protection of the dental pulp with biocompatible material
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of cases reporting postoperative pain
Délai: 12 months
|
Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
|
12 months
|
|
Number of cases reporting swelling
Délai: 12 months
|
Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
|
12 months
|
|
Number of cases reporting sinus
Délai: 12 months
|
Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
|
12 months
|
|
Number of cases reporting fistula
Délai: 12 months
|
Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
|
12 months
|
|
Number of cases reporting tooth mobility
Délai: 12 months
|
Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of cases reporting external root resorption
Délai: 12 months
|
Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
|
Number of cases reporting internal root resorption
Délai: 12 months
|
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
|
Number of cases reporting furcation involvement
Délai: 12 months
|
Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
|
Number of cases reporting widening of periodontal membrane space
Délai: 12 months
|
Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
|
Number of cases reporting periapical radiolucency
Délai: 12 months
|
Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
|
12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shereen E Taha, Professor, Cairo University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CEBD-CU-2014-11-3
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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