Comparing Impression Techniques for Maxillary Complete Denture Retention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single step PVS impression, Conventional two-step PVS impression.
- Who it may be relevant to
- Registry conditions: Denture Retention, Patient Satisfaction. Basic parameters: 35 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Two Impression Techniques on Retention of Maxillary Complete Denture in Pakistani Population: A Double-blinded Crossover Randomized Controlled Trial
Overview
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.
Interventions
- 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). - Procedure Conventional two-step PVS impression
Border molding with heavy-body PVS first, followed by wash impression with light-body PVS
Primary outcome measures
- Retention of maxillary denture using digital force meter [Time frame: 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 (2)
- Patient satisfaction with impression methods via the Burdens in Dental Impression-Making Questionnaire (BiDIM-Q) [Time frame: 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. [Time frame: At 2 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06497621 · 2023-8450-25606