Bite timing in lower overdentures supported by conventional versus mini dental implants
Evaluation of The Occlusion and Dis-Occlusion Time in Mandibular Single Overdentures Supported by Conventional Versus Mini- Dental Implants; A Parallel Blinded Randomized Clinical Trial
This test will see if lower overdentures attached to two conventional implants or four mini-implants change bite contact and release times for people who have lost all lower teeth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 55 Years to 70 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT07256106 on ClinicalTrials.gov |
What this trial studies
Twenty-eight patients with completely edentulous lower jaws will be recruited from the Prosthodontics Department at Ain-Shams University. Participants will be randomized with allocation concealment handled by a single postgraduate student to receive either an immediately loaded mandibular overdenture on two conventional implants or one on four immediately loaded mini-implants. The primary outcomes are occlusion and disocclusion times measured after prosthetic rehabilitation, with the Kapur index as a secondary outcome. Patients with conditions that may affect osseointegration (for example uncontrolled diabetes, pregnancy, or current bisphosphonate therapy) will be excluded.
Who should consider this trial
Good fit: Ideal candidates are adults with completely edentulous mandibular ridges, sufficient inter-arch space, a restored maxillary arch, good oral hygiene, and motivation for implant-retained overdentures.
Not a fit: Patients with uncontrolled systemic diseases affecting bone healing, current bisphosphonate treatment, pregnancy, inadequate bone volume, or poor oral hygiene are unlikely to benefit or may be excluded.
Why it matters
Potential benefit: If successful, the results could help clinicians choose the implant approach that provides better bite contact timing and potentially improved comfort and function for lower overdenture wearers.
How similar studies have performed: Previous clinical reports have shown acceptable retention and outcomes for mini-implant–retained mandibular overdentures, but direct comparisons of occlusion and disocclusion time between conventional and mini-implant protocols are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with completely edentulous mandibular ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration, * enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures * good oral hygiene and motivation. Exclusion Criteria: * The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.
Where this trial is running
Cairo and 1 other locations
- Faculty of Dentistry Ain Shams University — Cairo, Egypt (Recruiting)
- Faculty of Dentistry Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed Mohamed, MD — Faculty of dentistry, ain shams university
- Study coordinator: ahmed mohamed, MD
- Email: ahmedmostafa@dent.asu.edu.eg
- Phone: 01111191337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.