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NCT Number: NCT07080164

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

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./

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Key information

Conditions

Complete Edentulism

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mini implant retained overdenture

Other

mini implant retained overdenture

Primary outcomes

  1. OHRQoL

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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