Socket Shield Technique Versus Early Implant Placement Wi... | NCT05261334

Studies
Socket Shield Technique Versus Early Implant Placement With Contour Augmentation

NCT05261334

Sponsor

Iman Abd-ElWahab Radi, PhD

Status

Unknown status

Last Update Posted

Mar 25, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Bone Loss
Bone Resorption

Interventions

contour augmentation

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

Mar 2022

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

Mar 31, 2022Estimated

Primary Completion Date

Mar 31, 2023Estimated

Completion Date

Sep 1, 2023Estimated

First Submitted Date

Jan 28, 2022

First Submission Date that Met QC Criteria

Feb 26, 2022

First Posted Date

Mar 2, 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

Mar 11, 2022

Last Update Posted Date

Mar 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Iman Abd-ElWahab Radi, PhD, Professor of Prosthodontics, Faculty of Dentistry, Cairo University, Cairo UniversitySponsor-Investigator

Lead Sponsor

Iman Abd-ElWahab Radi, PhDOTHER

Collaborators

Not provided

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

comparing socket shield technique with early implant placement with contour augmentation in preserving the bone contour

Detailed Description

comparing immediate implant placement with socket shield technique and final crown after 3 months with extraction and after 4 to 8 weeks implant placement with contour bone augmentation then after 3 to 4 months final crown delivery

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
socket shield technique	Active Comparator	immediate implant placement with socket shield technique	Procedure: contour augmentation
contour augmentation	Active Comparator	early implant placement with contour bone augmentation	Procedure: contour augmentation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
contour augmentation	Procedure	early implant placement with contour bone augmentation	contour augmentation socket shield technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
facial bone thickness	using superimposed CBCT images	12 months

Secondary Outcomes

Measure	Description	Time Frame
facial bone height changes	using superimposed CBCT images	12 months
Soft tissue height changes	using superimposed intraoral scans

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-restorable maxillary teeth in the esthetic zone
Intact adjacent teeth
Adequate palatal and apical bone that allows achieving implant primary stability.
Type I socket
≥18 years
≤ 60 years
Systemically healthy patients

Exclusion Criteria:

Extraction sockets with acute or chronic infection or with adjacent infected teeth
Heavy Smokers > than 10 cigarettes daily
Cancer patients undergoing radiotherapy or chemotherapy during or within the last 6 months.
Unmotivated patients to maintain adequate oral hygiene to follow up.
Patients with physical disabilities that could affect follow up.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo		11553	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001862	Bone Resorption

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided