Splinted and Unsplinted OT Bridge Systems in Screw Retain... | NCT05031156

Studies
Splinted and Unsplinted OT Bridge Systems in Screw Retained Implant Restoration

NCT05031156

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Sep 1, 2021Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

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

Interventions

Splinting of OT Bridge system

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2021Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Jun 7, 2022Estimated

First Submitted Date

Aug 29, 2021

First Submission Date that Met QC Criteria

Aug 29, 2021

First Posted Date

Sep 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2021

Last Update Posted Date

Sep 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-splinting of OT Bridge system	Active Comparator	Leaving the dental implants abutments solitary followed by denture pick up	Procedure: Splinting of OT Bridge system
splinting of OT Bridge	Experimental	Splinting of implants abutments using titanium wire then followed by denture pick up	Procedure: Splinting of OT Bridge system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Splinting of OT Bridge system	Procedure	splinting of implant abutment using titanium wire followed by pick up using the patient's denture	non-splinting of OT Bridge system

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tasneem El Mashad, Master degree holder	Contact	01005754571	+02	tasneem.elmashad@gmail.com

Overall Officials

Name	Affiliation	Role
Tasneem El Mashad	Cairo University	Principal Investigator

Locations

Not provided