Comparing Impression Techniques for Maxillary Complete Denture Retention

Not Applicable

Not yet recruiting

• Conditions: Patient Satisfaction; Denture Retention
• Interventions: Procedure: Single step PVS impression; Procedure: Conventional two-step PVS impression

• Registration Number: NCT06497621
• Lead Sponsor: Aga Khan University

Brief Summary

The primary objective of this protocol is to compare retention in maxillary complete dentures using single-versus two-step Poly-vinyl Siloxane (PVS) impressions in edentulous patients at denture delivery. Secondary objectives include assessing patient satisfaction with impression methods and denture satisfaction after a two-month adaptation and comparing post-delivery adjustment visits.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-03
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Start: 2025-07-01
• Primary Completion: 2026-08-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients with mild to moderately resorbed maxillary alveolar ridge
• Patients with bimaxillary edentulous arches
• Patients aged between 35 to 85 years willing to participate in the study
• Patients who could be available for follow up visits

Exclusion Criteria

• Patients with palatal torus or bony exostoses or severe undercuts in the maxillary arch
• Patients with uncontrolled diabetes, osteoporosis, osteomalacia and osteopenia
• Patients with xerostomia
• Patients with mucosa covering the denture bearing area with signs of inflammation, ulceration, or hyperplasia.
• Patients undergoing radiotherapy or chemotherapy or maxillofacial surgery
• Patients suffering from maxillofacial trauma
• Patients with neuromuscular disorders
• Patients with clinical signs and symptoms of temporomandibular joint dysfunction
• Patients with highly resorbed maxillary ridge and/ or flabby ridge
• Patient with hypersensitivity to silicone materials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single step PVS impression	Single step PVS impression	Single-step final impression method for complete denture fabrication using medium body PVS for border molding and wash impression in a single-step (i.e., one insertion of impression tray in mouth).
Conventional two-step PVS impression	Conventional two-step PVS impression	Two-step final impression method for complete denture fabrication, i.e., border molding with heavy-body PVS first, followed by wash impression with light-body PVS.

Primary Outcome Measures

Name	Time	Method
Retention of maxillary denture using digital force meter	At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)	Three readings will be taken for each maxillary denture using digital force meter, and an average will be calculated in units for Newton (N) or Kg.m/s2.

Secondary Outcome Measures

Name	Time	Method
Denture satisfaction using the Denture Satisfaction (DS) questionnaire.	At 2 months	The questionnaire comprises 11 questions, answered on a 4-point Likert-type scale to assess the patient's experience with the dentures provided.
Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q)	At the delivery appointment for each denture at an average of 2.5 week from the start of denture fabrication and at 8th week (+/- 3 days)	The questionnaire consists of 12 questions covering various aspects of the impression-making process. Prosthodontists will request patients to score each question from 1 to 100 to gauge their response. A higher score for an aspect of the impression-making procedure will indicate a higher degree of satisfaction.