Patient's Satisfaction of Mandibular Implant Supported Overdentures With Reduced Denture Base Ext… (NCT06850558) | Clinical Trial Compass
CompletedNot Applicable
Patient's Satisfaction of Mandibular Implant Supported Overdentures With Reduced Denture Base Extensions.
Egypt20 participantsStarted 2024-01-04
Plain-language summary
This study aimed to compare reduced (partially extended) denture bases with fully extended bases regarding patient satisfaction, oral health-related quality of life (OHRQoL), and masticatory efficiency.
A within-subject study design was carried out; involving 20 completely edentulous participants aged 50-75 years, who received newly constructed conventional complete denture. Four parallel implants were installed in the interforaminal region, implant overdenture (IOD) retained by bar attachment was constructed for each patient and were provided with two different overdenture designs: (1)firstly a fully extended denture base (FIOD) (2) then a reduced (partially extended) denture base (RIOD). Each patient allowed to wear each types of overdentures for a period of 3 months prior to evaluation. The following outcome measures were assessed: Patient satisfaction, the Oral Health Impact Profile (OHIP-14), and Chewing efficiency were assessed.
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:
* Age between 50 and 75 years.
* Completely edentulous mandibular arch with adequate bone volume (≥10 mm in height and ≥ 6 mm in width at the implant site) and density to allow placement of 4 osseointegrated implants in the interforaminal region.
* Good general health, with no history of systemic diseases that would contraindicate implant placement or the use of overdentures.
* Presence of sufficient inter-arch space for overdenture construction and implant placement.
* No history of severe bruxism or parafunctional habits that could affect implant stability or prosthetic outcomes.
* Ability to understand and complete questionnaires regarding patient satisfaction and quality of life.
* Willingness to comply with the study protocol and attending follow-up visits.
Exclusion Criteria:
* History of temporomandibular joint disorders.
* Neurological disorders affecting masticatory function.
* Presence of uncontrolled systemic diseases.
* Cognitive impairments affecting the ability to provide informed consent.
* Severe bone resorption or contraindications for implant placement (e.g., insufficient ridge height or width).
* Presence of systemic diseases affecting oral health (e.g., uncontrolled diabetes, systemic inflammatory disorders).
* Inability to wear dentures for extended periods or intolerance to the study protocol
7\. Inability to wear dentures for extended periods or intolerance to the study protocol
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.