Comparing Impression Techniques for Maxillary Complete Denture Retention
35 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Retention of maxillary denture using digital force meter
Timeframe: 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)