The Use of a New Safe Angle Position for Implant Placemen... | NCT05436158

Studies
The Use of a New Safe Angle Position for Implant Placement in the Anterior Region.

NCT05436158

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 28, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Immediate Implant Placement
Esthetic Zone
Anterior Maxilla
Safe Angle Position

Interventions

Implant placement in the safe angle position in the anterior maxilla

Countries

Egypt

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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Aug 2022Estimated

Completion Date

Sep 2022Estimated

First Submitted Date

Jun 19, 2022

First Submission Date that Met QC Criteria

Jun 23, 2022

First Posted Date

Jun 28, 2022Actual

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

Jun 23, 2022

Last Update Posted Date

Jun 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nesma Mohamed Fouad Shemais, Lecturer in the department of Oral Medicine & Periodontology, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

There is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).

The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.

The aim of the present study was to demonstrate how immediate implants in the safe angle position can be predictably achieve proper implant positioning, better esthetics and emergence profile as well as less stresses on the implant.

Detailed Description

Immediate implants are implants inserted immediately after surgical extraction of the teeth to be replaced. Creation of an anatomically correct emergence profile is one of the most important aspects in providing an esthetically pleasing implant-supported restoration. Dentists understand the risks involved when restored prostheses are subjected to non-axial loading. It has always been recommended to direct occlusal loads as close to the long axis of the fixture as possible. However, it is known that the loading on angled abutments is mostly off-axis, which raises the concern of how angled abutments generally perform with such an unfavourable loading regimen.

The possibility of having a specific safe angle to place implants opens new interesting perspectives for immediate placement of dental implants.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implant placement in the safe angle position in the anterior maxilla	Other	After assessing the CBCT of patients, the immediate implants will be assessed if they were placed in the safe zone. the safe zone is described as; that there is an angle between the intersection of the incisal long axis perpendicular to the palate or the occlusal plane, and the long axis of the root. When this relation is shifted more palatal, where the incisal plane line will be at the cingulum position or slightly palatal to it, it is named the safe angle position. The more palatal relocation to the cingulum is performed according to the availability of palatal bone, the occlusion with the opposing dentition, the type of the restoration (screw vs cemented).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence of the implant in the safe angle	binary (Y/N) from CBCT	6 months
use of angled or straight abutment	Binary (straight/angled)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Pink Esthetic Score	Pink Esthetic Score (1-14)	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with immediate implants in the anterior region
Patient with preoperative and postoperative CBCT
Provide informed consent.

Exclusion Criteria:

patients without a preoperative CBCT.
2- patients without an informed consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with immediate implants in the anterior region

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nesma M Shemais, PhD	Contact	01005615697		nesma.shemais@dentistry.cu.edu.eg
Noha A Ghallab, PhD	Contact			noha.ghallab@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Noha A Ghallab, PhD	Professor of Oral Medicine & Periodontology	Study Chair
Ahmed I Abou- El-Fettouh, MSc	MIU	Principal Investigator
Abdelrahman Zohny, BDs

Locations

Facility	Status	City	State	ZIP	Country	Contacts
International Dental Continuing Education	Recruiting	Cairo	Maadi	11728	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided