Implant Placement in Horizontally Deficient Maxillary Aes... | NCT05274256

Studies
Implant Placement in Horizontally Deficient Maxillary Aesthetic Zone With Simultaneous Soft Tissue Augmentation

NCT05274256

Sponsor

Cairo University

Status

Completed

Last Update Posted

Mar 10, 2022Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Implant or Graft; Rejection

Interventions

implant placement with simultaneous soft tissue 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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Jul 1, 2020Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Feb 2, 2022

First Submission Date that Met QC Criteria

Mar 1, 2022

First Posted Date

Mar 10, 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 1, 2022

Last Update Posted Date

Mar 10, 2022Actual

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

Tooth extraction in maxillary esthetic zone is accomplished with great dimensional changes of the alveolar ridge, different procedures have been tested to compensate these dimensional alteration, such as Hard bone augmentation, Soft tissue augmentation Or augmentation of both together. Hence, the present study aimed to evaluate pink esthetic score, clinical implant stability and bucco-palatal dimensional changes in the maxillary esthetic zone treated by implant placement with simultaneous soft tissue augmentation using de-epithelialized free gingival graft.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with missing teeth in maxillary aesthetic zone	Other		Procedure: implant placement with simultaneous soft tissue augmentation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
implant placement with simultaneous soft tissue augmentation	Procedure	implant placement with simultaneous soft tissue augmentation using De-epithelialized free gingival graft and immediate temporization in the maxillary aesthetic zone .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pink esthetic score	pink esthetic score evaluated pre-operative and 6 month post-operative (PES scale 0-1-2 , ''2'' the best , ''0'' the worst	6 month

Secondary Outcomes

Measure	Description	Time Frame
Implant stability quotient		6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient of both sexes with missing teeth in the maxillary aesthetic zone.

Exclusion Criteria:

Patients with systemic disease that may affect bone quality or bone healing.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012059	Rejection, Psychology

Ancestor Terms

ID	Term
D012919	Social Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided