This randomized controlled trial compares a mandibular overdenture retained by one implant placed in the parasymphyseal or canine region with a mandibular overdenture retained by two implants placed in the interforaminal region in completely edentulous adults. Primary outcomes are oral health-related quality of life, patient satisfaction, and masticatory performance measured by a two-color chewing gum mixing test, assessed at baseline before implant surgery and at 3, 6, and 12 months after overdenture insertion.
Who can participate
Age range
40 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:
* Men and women ≥40 years.
* ASA I-II; favorable general health or adequately controlled systemic disease (e.g., hypertension, diabetes).
* Skeletal Class I relationship.
* Completely edentulous mandible and maxilla.
* Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention/stability.
* Adequate anterior mandibular bone for implant ≥3.5×10 mm confirmed on CBCT; no bone augmentation needed.
* Normal mucosal resilience (\~2 mm displacement).
* Implant sites healed ≥4 months since extraction.
* Willingness to be randomized and attend follow-ups; written informed consent.
* Primary stability target ≥25 N-cm.
Exclusion Criteria:
* Uncontrolled systemic disease; neurodegenerative disease; osteoporosis requiring antiresorptives.
* Chronic systemic antibiotics/steroids; bleeding disorders; active cancer therapy; metabolic bone disease; HIV.
* Investigational drug use within 30 days.
* Alcohol dependence/illicit drug use; xerostomia (stimulated flow \<0.7 mL/min).
* Heavy smoking \>20 cigarettes/day.
* TMD/orofacial pain; severe bruxism; moderate/severe cognitive impairment.
* Prior implant therapy.
* Non-adherence risk or inability to attend longitudinal visits.
* Insufficient prosthetic space for attachment housing: inter-arch vertical distance \<8.5 mm at parasymphyseal/canine region.
* Concurrent participation in another interventional study.
* Erosive lichen planus or other significant ora…
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
Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score
Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion
2
Change from baseline in McGill Denture Satisfaction Questionnaire (MDSQ) total score
Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.
3
Change from baseline in masticatory performance measured by two-color chewing gum mixing test (Variance of Hue [VoH])
Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.