Soft Tissue Evaluation Around Implants Using Prf or a Pal... | NCT03224442

Studies
Soft Tissue Evaluation Around Implants Using Prf or a Palatal Pedicle

NCT03224442

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Nov 7, 2017Actual

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Soft Tissue Augmentation

Interventions

PRF
Palatal Pedicle

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

Nov 2017

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

Dec 1, 2017Estimated

Primary Completion Date

Sep 1, 2018Estimated

Completion Date

Oct 1, 2018Estimated

First Submitted Date

Jul 12, 2017

First Submission Date that Met QC Criteria

Jul 19, 2017

First Posted Date

Jul 21, 2017Actual

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

Nov 5, 2017

Last Update Posted Date

Nov 7, 2017Actual

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

Clinical Evaluation of Peri-Implant Soft Tissue Around Immediately Placed Implants Using PRF Membrane Versus The Palatal Pedicle Soft Tissue Graft: A Randomized Controlled Clinical Trial.

Detailed Description

Immediate implant will be place and followed by soft tissue augmentation by PRF or palatal pedicle and the primary outcome is the pink esthetic score

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

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRF with immediate implants	Experimental	Immediate implants placed and covered with two prf layers	Procedure: PRF
palatal pedicle graft	Active Comparator	immediate implant placement followed by soft tissue augmentation by oalatal pedicle graft	Procedure: Palatal Pedicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRF	Procedure	soft tissue augmentation by prf	PRF with immediate implants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pink Esthetic Score	photographs	5 months

Secondary Outcomes

Measure	Description	Time Frame
facial gingival thickness	probe	5 months
mid-buccal gingival level	probe	5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Absence of periodontal disease or a periapical infection
Adequate native bone to achieve implant primary stability
The need for a single-tooth replacement in the anterior maxilla (from the second bicuspid to the second bicuspid), subsequent to an inevitable tooth extraction.

Exclusion criteria

Systemic conditions/disease that contraindicated surgery
Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
Patients who have inadequate interarch space for the prosthetic part.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided