Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration

Study Overview
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Brief Summary
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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

Official Title
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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
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Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System

Intervention / Treatment
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* Procedure: Splinting of OT Bridge system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-splinting of OT Bridge system<br>Leaving the dental implants abutments solitary followed by denture pick up | Procedure: Splinting of OT Bridge system<br>* splinting of implant abutment using titanium wire followed by pick up using the patient's denture<br>|
| Experimental: splinting of OT Bridge<br>Splinting of implants abutments using titanium wire then followed by denture pick up | Procedure: Splinting of OT Bridge system<br>* splinting of implant abutment using titanium wire followed by pick up using the patient's denture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal Bone loss | Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system | 3 monts | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early implant failure | not fulfilling one of Alberksston implant success criteria | 3 months |