NCT07475507Active, not recruitingNot Applicable
Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinical Trial
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Cairo University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Marginal bone loss
Study Overview
Brief Summary
A fixed all-on-four prosthesis will be constructed for the lower arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Completely edentulous patients requesting a fixed, implant supported restoration.
- •Patients aged from 45 to 60, able to sign an informed consent will be considered eligible for this trial.
- •Implant sites must allow the placement of four implants.
- •Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
- •In case of post-extraction sites, they must have been healed for at least 3 months before being treated in the study.
- •Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)
Exclusion Criteria
- •Patients with poor oral hygiene and motivation.
- •Female patients taking any medical treatment for management of osteoporosis.
- •Drug abusers.
- •Psychiatric problems or unrealistic expectations.
- •Patients with active infection or inflammation in the planned implant area at the time of implant placement.
- •Immuno-compromised patients (Diabetic with HBA1C > 7 or patients undergoing chemo or radiotherapy or bisphosphonates)
Arms & Interventions
Titanium framework reinforced all on four prosthesis
Other
Active Comparator: Titanium reinforced fixed all-on-four prosthesis
Intervention: Titanium framework reinforced all on four prosthesis (Other)
PEEK framework reinforced all on four prosthesis
Other
Intervention: PEEK framework reinforced all on four prosthesis (Other)
Outcomes
Primary Outcomes
Marginal bone loss
Time Frame: 12 months at intervals (0,3,6,9and 12 months)
Marginal bone loss around each dental implant using parallel technique in digital periodical radiographs which will be measured in mm from the crestal bone level at the implant platform.
Secondary Outcomes
- Bone density(12 months at intervals (0,3,6,9and 12 months))
Investigators
Ahmed Mohamed Hamed Khalaf
Assistant lecturer of Prosthodontics
Cairo University
Study Sites (1)
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