NCT05031156UnknownNot Applicable
Effect of Mandibular Immediately Loaded, Screw-retained Splinted and Non-splinted OT Bridge Implant Restoration on Bone Height Changes of Completely Edentulous Patients (A Randomized Clinical Trial)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 35
- Primary Endpoint
- Marginal Bone loss
Study Overview
Brief Summary
Evaluation of Bone level changes around dental implants in All on 4 cases with immediate loading using conversion denture and OT Bridge system either splinted or not
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
- •Patients aged from 40 to 70, 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-extractive sites, they must have been healed for at least 3-month 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.
- •Pregnancy or nursing.
- •Drug abusers.
- •Psychiatric problems or unrealistic expectations.
- •Patients with infection and or inflammation in the area intended for implant placement.
- •Patients participating in other studies, if the present protocol cannot be properly adhered to.
- •Patients with signs of hyperactive muscles.
Outcomes
Primary Outcomes
Marginal Bone loss
Time Frame: 3 monts
Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system
Secondary Outcomes
- Early implant failure(3 months)
Investigators
tasneem gamal youssef el mashad
Assistant lecturer of Prosthodontics
Cairo University
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