Comparing Impression Techniques for Maxillary Complete Denture Retention

NCT06497621 | Not Yet Recruiting

• 1 other identifier: 2023-8450-25606
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Denture Retention; Patient Satisfaction

Keywords

Crossover; Complete Denture; Retention; Poly-vinyl siloxane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• Denture satisfaction using the Denture Satisfaction (DS) questionnaire.

  At 2 months

Other Outcomes (1)

• Number of post-insertion visits for denture adjustment

  At the end of adjustment period of each denture at an average of 1-month after denture delivery

Study Arms (2)

Single step PVS impression

EXPERIMENTAL

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

Conventional two-step PVS impression

ACTIVE COMPARATOR

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

Interventions

Single step PVS impression PROCEDURE

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).

Single step PVS impression

Conventional two-step PVS impression PROCEDURE

Border molding with heavy-body PVS first, followed by wash impression with light-body PVS

Conventional two-step PVS impression

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Kazmi MR Principle investigator, FCPS

CONTACT

+923212412423; syed.murtaza@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share