Denture Retention, Patient Satisfaction
Conditions
Keywords
Crossover, Complete Denture, Retention, Poly-vinyl siloxane
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.
Interventions
PROCEDURESingle 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).
PROCEDUREConventional two-step PVS impression
Border molding with heavy-body PVS first, followed by wash impression with light-body PVS
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention of maxillary denture using digital force meter | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Denture satisfaction using the Denture Satisfaction (DS) questionnaire. | At 2 months | The questionnaire comprises 11 questions, answered on a 4-point Likert-type scale to assess the patient's experience with the dentures provided. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | The research team will record the post-delivery visits required to adjust dentures fabricated from two different impression methods in the study Pro-forma. |
Contacts
Primary ContactKazmi MR Principle investigator, FCPS
Outcome results
None listed