Socket Shield With Immediate Implant Stability | NCT04882761

Studies
Socket Shield With Immediate Implant Stability

NCT04882761

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

May 12, 2021Actual

Enrollment

16Actual

Phase

Phase 4

Conditions

Dental Implant

Interventions

Dental implant

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

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2017Actual

Primary Completion Date

Jan 20, 2021Actual

Completion Date

Feb 24, 2021Actual

First Submitted Date

Feb 27, 2021

First Submission Date that Met QC Criteria

May 6, 2021

First Posted Date

May 12, 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

May 6, 2021

Last Update Posted Date

May 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate socket shield technique either placing implant in direct contact to tooth fragment versus gap created between the tooth and implant.

Detailed Description

Patients with a non-restorable tooth located in anterior maxillary arch was included in this study, patients were divided into two groups, eight implants per group, both groups had socket shield, group 1 will have implant in direct contact with shield, second group had a gap between dental implant and shield. soft tissue stability, bone width and implant stability was assessed preoperatively, immediate and 6 months postoperative.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Socket shield in direct contact with dental implant	Active Comparator	eight partially extracted sockets where implant (Neobiotech) was placed in direct contact to socket shield	Device: Dental implant
Socket shield with gap and xenograft with dental implant	Active Comparator	eight partially extracted sockets where a gap was left between implant (Neobiotech) and socket shield	Device: Dental implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental implant	Device	Comparative	Socket shield in direct contact with dental implant Socket shield with gap and xenograft with dental implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Soft tissue stability	Pink esthetic score	6 months postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Bone stability	By Ostell	6 months postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a non-restorable tooth located in anterior maxillary arch (upper right second premolar to upper left second premolar). Tooth to be extracted is endodontically treated and free from periapical infection.
Systemic free patients according to modified Cornell medical index (Brodmank and Erdmann 1949).
Patients with good compliance.

Exclusion Criteria:

Teeth with current acute periapical infection or sinus tracts.
Heavy smokers and patients with bruxism habits.
Patients with poor oral hygiene or not willing to perform oral hygiene measures.
Vulnerable groups (as pregnant females and decisionally impaired individuals).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Doaa Adel-Khattab, PhD	Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Doaa Khattab		Cairo	Abbassia	11566	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

Intervention Browse Module

MeSH Terms

ID	Term
D015921	Dental Implants

Ancestor Terms

ID	Term
D003764	Dental Materials
D001697	Biomedical and Dental Materials
D017266	Dental Prosthesis
D011476	Prosthodontics

Browse Leaves

Not provided

Browse Branches

Not provided