Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration

NCT ID: NCT05031156

Last Updated: 2021-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-06-07

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-splinting of OT Bridge system

Leaving the dental implants abutments solitary followed by denture pick up

Group Type ACTIVE_COMPARATOR

Splinting of OT Bridge system

Intervention Type PROCEDURE

splinting of implant abutment using titanium wire followed by pick up using the patient's denture

splinting of OT Bridge

Splinting of implants abutments using titanium wire then followed by denture pick up

Group Type EXPERIMENTAL

Splinting of OT Bridge system

Intervention Type PROCEDURE

splinting of implant abutment using titanium wire followed by pick up using the patient's denture

Interventions

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Splinting of OT Bridge system

splinting of implant abutment using titanium wire followed by pick up using the patient's denture

Intervention Type PROCEDURE

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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tasneem gamal youssef el mashad

Assistant lecturer of Prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tasneem El Mashad

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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Tasneem El Mashad, Master degree holder

Role: CONTACT

01005754571 ext. +02

Other Identifiers

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OTBridge

Identifier Type: -

Identifier Source: org_study_id

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