Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration

Not Applicable

• Conditions: Evaluate the Immediate Loading Implants in All on 4 Cases Using Conversion Denture and OT Bridge System
• Interventions: Procedure: Splinting of OT Bridge system

• Registration Number: NCT05031156
• Lead Sponsor: Cairo University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-29
• Study First Submitted QC: 2021-08-29
• Last Update Submitted: 2021-08-29
• Study First Posted: 2021-09-01
• Last Update Posted: 2021-09-01
• Study Start: 2021-09-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-splinting of OT Bridge system	Splinting of OT Bridge system	Leaving the dental implants abutments solitary followed by denture pick up
splinting of OT Bridge	Splinting of OT Bridge system	Splinting of implants abutments using titanium wire then followed by denture pick up

Primary Outcome Measures

Name	Time	Method
Marginal Bone loss	3 monts	Measures the changes around the dental implants along the healing period using paralleling technique radiograph and DIGORA system

Secondary Outcome Measures

Name	Time	Method
Early implant failure	3 months	not fulfilling one of Alberksston implant success criteria