NCT05924386 Marginal Bone Changes in Fixed All-on-Four Mandibular Prosthesis Using OT Bridge Attachment System
| NCT ID | NCT05924386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cairo University |
| Condition | Edentulous Jaw |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2025-05-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-12-01 with a primary completion date of 2025-05-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Group I (control) Edentulous mandible receiving all on four fixed mandibular prosthesis using conventionally screw retained multiunit abutments. Group II (intervention) Edentulous mandible receiving all on four fixed prostheses using OT bridge attachments system. For both groups, the implant sites will be prepared aided by the surgical template. 4 implants with length 11-13 mm will be placed, two anterior implants will be aligned in an axial orientation and two posterior implants will be distally aligned according to the all-on-four concept in the inter foraminal area. Implants will be ideally placed at bone level. For both groups: After implant placement and surgical guide removal, healing abutments ( will be connected during healing periods (eight to twelve weeks). Group I ( control) After eight to twelve weeks from implant placement, multiunit abutments with appropriate heights and angulations will be connected to the implants. Group II ( intervention) After eight to twelve weeks from implant placement, narrow- and low-profile OT Equator abutment will be screwed onto the implants according to the manufacturer. marginal bone changes and prosthetic complications are the outcomes Radiographic follow up will be performed for marginal bone changes Serial of standardized digital periapical radiographs using will be taken at the time fixed prosthesis insertion (baseline), 3,6,9,12 months. Type and incidence of prosthetic complications for the prothesis for each group will be evaluated in 3, 6,9 and 12 months, these complications included: loosening or fracture of the prosthetic screw, prosthesis mobility and fracture of the prosthesis.
Eligibility Criteria
Inclusion Criteria: Patients with completely edentulous patients * Aged 40 years or older. * Sufficient inter -arch space not less than 13 mm. * Good oral hygiene * Minimum bone height 10 mm and minimum bone diameter should be 6 mm Exclusion Criteria: * General contraindications for oral surgery * Heavy smokers (greater than 20 cigarettes a * Local acute or chronic infections * Substance abuse (drugs or alcohol) * Patients with neuromuscular or psychiatric disorders. * Treatment with intravenous bisphosphonates * Irradiation of the neck or head area in the past 5 years * Diabetic patients (HbA1c\>7.5%)
Contact & Investigator
nesma O elmosallamy
PRINCIPAL INVESTIGATOR
CAIRO UNIVERISTY
Frequently Asked Questions
Who can join the NCT05924386 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Edentulous Jaw. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05924386 currently recruiting?
Yes, NCT05924386 is actively recruiting participants. Contact the research team at nesma.osama@dentistry.edu.eg for enrollment information.
Where is the NCT05924386 trial being conducted?
This trial is being conducted at Cairo, Egypt, Cairo, Egypt.
Who is sponsoring the NCT05924386 clinical trial?
NCT05924386 is sponsored by Cairo University. The principal investigator is nesma O elmosallamy at CAIRO UNIVERISTY. The trial plans to enroll 20 participants.