Not Yet RecruitingNot Applicable

Evaluation of Oral Health-Related Quality of Life In Patients With Conventional Complete Dentures Versus Mini-Implant Retained Overdentures: A Randomized Clinical Trial

Egypt24 participantsStarted 2025-11-01

Plain-language summary

Mini-implants have emerged as a practical and less invasive solution for the rehabilitation of edentulous mandibles, offering reduced surgical complexity, lower cost, and faster healing compared to conventional implants. These advantages make them especially suitable for elderly patients or those with systemic health concerns or limited bone volume. Despite their growing clinical use, evidence from well-designed randomized controlled trials evaluating the impact of mini-implant-retained overdentures on patients' oral health-related quality of life (OHRQoL) is still scarce. Establishing this evidence is crucial for guiding treatment decisions in resource-constrained settings and improving the standard of care for edentulous individuals. This research aims to provide high-quality data on the effectiveness of mini-implants in improving OHRQoL, as measured by OHIP-14, compared to conventional dentures./

Who can participate

Age range30 Years

SexALL

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 mandible for a minimum period of 6 months Adult patients capable of understanding, cooperating, and providing informed consent Sufficient bone volume and interarch space in the anterior mandible to accommodate two mini-implants and overdenture attachments Good general health permitting minor oral surgical procedures Willingness to undergo follow-up visits and comply with study protocols Exclusion Criteria: * Systemic medical conditions that preclude implant surgery, including poorly controlled chronic diseases such as diabetes mellitus or disorders affecting bone metabolism. Patients taking medications known to affect bone metabolism (e.g., bisphosphonates, corticosteroids) Patients with physical or mental disabilities that impair oral hygiene maintenance or compliance Heavy smokers (\>10 cigarettes/day) Individuals unable or unwilling to attend scheduled follow-up or participate throughout the study duration Patients who can receive standard implants with no anatomical limitations

What they're measuring

OHRQoL

Timeframe: 1 year

Trial details

NCT IDNCT07080164

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-01

View on ClinicalTrials.gov More Complete Edentulism trials