Comparing Impression Techniques for Maxillary Complete Denture Retention

ConditionsDenture Retention Patient Satisfaction

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age35-80

SponsorAga Khan University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

Single step PVS impression
Procedure/Surgery
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
Procedure/Surgery
Border molding with heavy-body PVS first, followed by wash impression with light-body PVS

Treatment groups

35 Participants

are divided into 2 treatment groups

Group A: Single step PVS impressionExperimental treatment 1 intervention

Group B: Conventional two-step PVS impressionActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

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 outcomes

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.

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.

The questionnaire comprises 11 questions, answered on a 4-point Likert-type scale to assess the patient's experience with the dentures provided.

Time frame

At 2 months

Other outcomes

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.

Time frame

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aga Khan University

Lead sponsor

Source ClinicalTrials.gov

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