Guided Creeping Technique (GCT) in Treating Gingival Rece... | NCT05101642

Studies
Guided Creeping Technique (GCT) in Treating Gingival Recession

NCT05101642

Sponsor

October 6 University

Status

Unknown status

Last Update Posted

Nov 1, 2021Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Gingival Recession

Interventions

Guided Creeping Technique (GCT)

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2021Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Jun 2022Estimated

First Submitted Date

Oct 20, 2021

First Submission Date that Met QC Criteria

Oct 20, 2021

First Posted Date

Nov 1, 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

Oct 20, 2021

Last Update Posted Date

Nov 1, 2021Actual

Name	Class
Ain Shams University	OTHER

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

A novel minimally invasive guided creeping technique (GCT) is suggested to treat gingival recessions.

Detailed Description

Background: Coronally advanced flap with connective tissue grafting in a conventional or minimally invasive approaches includes massive soft tissue reflection that reduce soft tissue support and compromise vascularity around the grafted material. In an attempt to preserve soft tissue support, graft stability and maximizing graft protection in treating recession defects the present novel minimally invasive guided creeping technique (GCT) is suggested.

Methods: Twelve patients, each contributing a single Cairo RT1 GR defect, were treated by guided creeping technique and completed the 6 months follow up. Clinical, evaluations were performed and differences among groups were analyzed.

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

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Guided Creeping Technique (GCT)	Experimental	Novel minimally invasive guided creeping technique	Procedure: Guided Creeping Technique (GCT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Guided Creeping Technique (GCT)	Procedure	Guided Creeping Technique (GCT) is a novel minimally invasive blind tunnel	Guided Creeping Technique (GCT)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recession Coverage	Measured in mm	Change from baseline to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Keratinized Tissue Width	Measured in mm	Change from baseline to 6 months
Keratinized Tissue Thickness	Measured in mm	Change from baseline to 6 months

Other Outcomes

Measure	Description	Time Frame
Patient Reported Outcome	Visual Analog Scale (VAS)	Through 14 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years of age
Systemically and periodontally healthy
Presence of isolated buccal Cairo RT1 gingival recessions
An identifiable CEJ
Affected teeth with at least 2mm attached gingiva.

Exclusion Criteria:

Smokers
Pregnancy
Using antiepileptic drugs
Using antibiotics for at least 20 days before surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Y Gamal, Professor	Faculty of Dentistry, October 6 University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
October 6 University		Giza		1211	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005889	Gingival Recession

Ancestor Terms

ID	Term
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided