Comparing Impression Techniques for Maxillary Complete Denture Retention

Effect of Two Impression Techniques on Retention of Maxillary Complete Denture in Pakistani Population: A Double-blinded Crossover Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patient Satisfaction; Denture Retention
• Intervention / Treatment: Procedure: Single step PVS impression; Procedure: Conventional two-step PVS impression

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kazmi MR Principle investigator, FCPS; Phone Number: +923212412423; Email: syed.murtaza@aku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: 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).
Active Comparator: 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.	Procedure: Conventional two-step PVS impression; Border molding with heavy-body PVS first, followed by wash impression with light-body PVS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of maxillary denture using digital force meter	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.	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q)	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.	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)
Denture satisfaction using the Denture Satisfaction (DS) questionnaire.	The questionnaire comprises 11 questions, answered on a 4-point Likert-type scale to assess the patient's experience with the dentures provided.	At 2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of post-insertion visits for denture adjustment	The research team will record the post-delivery visits required to adjust dentures fabricated from two different impression methods in the study Pro-forma.	At the end of adjustment period of each denture at an average of 1-month after denture delivery

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Crossover; Retention; Complete Denture; Poly-vinyl siloxane
• Other Study ID Numbers: 2023-8450-25606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No