Digital Versus Conventional Impression in Edentulous Patients With Flabby Ridge. (NCT07108322) | Clinical Trial Compass
CompletedNot Applicable
Digital Versus Conventional Impression in Edentulous Patients With Flabby Ridge.
Egypt26 participantsStarted 2023-03-30
Plain-language summary
The main goal of complete denture prosthodontics is to restore function, comfort, and aesthetics by replacing missing teeth and supporting structures. Flabby ridges, defined as mobile soft tissue on the alveolar ridge, pose challenges in creating stable dentures, as these tissues can displace under occlusal forces, compromising retention and support. Special impression techniques are necessary to manage flabby ridges effectively One widely accepted method is the window technique, which uses double spacers and window in the flabby tissue area. However, this technique is technically complex. This RCT aims to evaluate whether intraoral scanning (IOS) provides an alternative to the window technique for recording maxillary flabby ridges.
The hypothesis was that IOS will demonstrate superior clinical results in terms of both Retention and Patient satisfaction compared to the conventional window technique impression (WTI).
Who can participate
Age range
50 Years – 75 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:
* Completely edentulous patients with maxillary flabby ridge
* Absence of infectious diseases
* Systemic good health (ASA-1/ASA-2)
* Age between 50 and 75 years
* Willingness to cooperate throughout the data collection process.
Exclusion Criteria:
* Presence of any remaining teeth
* Inability to comprehend the study's objectives and procedures
* ridge defect or lesion
* Postoperative scarring on the ridge
* Limitations in mouth opening.
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
patient satisfaction
Timeframe: Baseline, 3 months and 6 months
Trial details
NCT IDNCT07108322
SponsorDelta University for Science and Technology