Comparing Impression Techniques for Maxillary Complete Denture Retention

NCT ID: NCT06497621

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Single step PVS impression

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

Conventional two-step PVS impression

Intervention Type: PROCEDURE

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

Interventions

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).

Intervention Type: PROCEDURE

Conventional two-step PVS impression

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Syed Murtaza Raza Kazmi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kazmi MR Principle investigator, FCPS

Role: CONTACT

syed.murtaza@aku.edu

+923212412423

Other Identifiers

2023-8450-25606

Identifier Type: -

Identifier Source: org_study_id