Comparison of Open-Mouth and Closed-Mouth Impression Techniques for Complete Dentures
Comparison of Open Mouth Vs Closed Mouth Edentulous Impression Technique: A Hospital Based Study
This randomized controlled trial compares two final impression techniques for complete dentures, the open mouth technique and the closed mouth technique. Completely edentulous adults with well-formed ridges will be randomly assigned 1:1 to one of the two techniques. All dentures will be made by a single operator using the same materials and laboratory. Six weeks after insertion, an examiner blinded to group allocation will assess denture retention using the Kapur index, and patient satisfaction will be recorded using a 5-item Likert questionnaire.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
In the open mouth group, border molding and the wash impression are made with the patient's mouth open and no occlusal contact. In the closed mouth group, occlusal rims are attached to the custom trays at a predetermined occlusal vertical dimension, and the impression is made while the patient closes and performs functional movements. Jaw relations, try-in, and insertion follow the same protocol for both groups. Retention is scored separately for the maxillary and mandibular dentures, with a score of 2 or 3 counted as adequate. Satisfaction scores range from 5 to 25, and a score of 16 or above counts as satisfied.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Fatima Shakeel, BDS
- Numéro de téléphone: +92 335 8416673
- E-mail: fatimasmir25@gmail.com
Lieux d'étude
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan, 46000
- Department of Prosthodontics, Watim Medical and Dental College, Rawat, Rawalpindi, Punjab, Pakistan
-
Contact:
- Fatima Shakeel, BDS
- Numéro de téléphone: +92 335 8416673
- E-mail: fatimasmir25@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adults aged 18 to 70 years
- Completely edentulous in both maxilla and mandible for at least six months, confirmed by clinical examination and orthopantomogram
- Well-formed ridges, ACP classification Class I or Class II
Exclusion Criteria:
- Flabby or hypermobile ridges
- Atrophic ridges
- Ridges with bony exostosis
- Active oral pathology
- History of radiotherapy to head and neck
- Uncontrolled systemic disease
- Neuromuscular or neurological disorders
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group A: Open Mouth Technique
Final impressions made in custom trays with sectional border molding using low fusing impression compound and a zinc oxide eugenol wash, with the mouth open and no occlusal contact. |
Secondary impression of the edentulous arch made in a custom acrylic tray. Border molding is done in sections with low fusing impression compound, followed by a zinc oxide eugenol wash impression. The clinician manipulates the tissues and the patient performs functional movements, with the mouth open and no occlusal contact. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.
Autres noms:
|
|
Comparateur actif: Group B: Closed Mouth Technique
Final impressions made in custom trays with attached occlusal rims set to a predetermined vertical dimension. Border molding and the wash impression are made while the patient closes into occlusion and performs functional movements. |
Secondary impression made in custom trays with occlusal rims attached and adjusted to a predetermined occlusal vertical dimension. Maxillary and mandibular trays are inserted together. Border molding with low fusing impression compound and a zinc oxide eugenol wash impression are made while the patient closes into occlusion and performs functional movements, recording the denture bearing areas under simulated functional load. All steps are done by a single trained operator using the same materials and laboratory as the comparison group.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adequate retention of maxillary denture
Délai: 6 weeks after denture insertion
|
Kapur index score (0 nil, 1 poor, 2 fair, 3 good) assessed by a blinded examiner. A score of 2 or 3 is adequate and 0 or 1 is inadequate. |
6 weeks after denture insertion
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adequate retention of mandibular denture
Délai: 6 weeks after denture insertion
|
Kapur index score assessed the same way as the maxillary denture. |
6 weeks after denture insertion
|
|
Patient satisfaction
Délai: 6 weeks after denture insertion
|
5-item Likert questionnaire covering retention, comfort, mastication, phonetics, and overall satisfaction, with a total score of 5 to 25. A score of 16 or above counts as satisfied. |
6 weeks after denture insertion
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Fatima Shakeel, BDS, Watim Medical and Dental College
- Directeur d'études: Zarah Afreen, BDS, FCPS, Watim Medical and Dental College
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
Autres numéros d'identification d'étude
- WMDC/R&D(ERB)/2025/241
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Individual participant data will not be shared publicly to protect participant confidentiality. Summary results will be published in a peer-reviewed journal.
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .