Comparing Impression Techniques for Maxillary Complete Denture Retention

Aga Khan University

Status: Not yet enrolling

Conditions: Patient Satisfaction; Denture Retention

Treatments: Procedure: Conventional two-step PVS impression; Procedure: Single step PVS impression

Study type: Interventional

Funder types: Other

Identifiers

NCT06497621

2023-8450-25606

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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35 participants in 2 patient groups

Single step PVS impression

Experimental group

Description:

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).

Treatment:

Procedure: Single step PVS impression

Conventional two-step PVS impression

Active Comparator group

Description:

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.

Treatment:

Procedure: Conventional two-step PVS impression