Guided Creeping Technique (GCT) in Treating Gingival Recession
Primary Purpose
Gingival Recession
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Guided Creeping Technique (GCT)
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring Minimally Invasive Surgery, Tunneling Techniques, Gingival Recession, Creeping Attachment
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
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Guided Creeping Technique (GCT)
Arm Description
Novel minimally invasive guided creeping technique
Outcomes
Primary Outcome Measures
Recession Coverage
Measured in mm
Secondary Outcome Measures
Keratinized Tissue Width
Measured in mm
Keratinized Tissue Thickness
Measured in mm
Full Information
NCT ID
NCT05101642
First Posted
October 20, 2021
Last Updated
October 20, 2021
Sponsor
October 6 University
Collaborators
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05101642
Brief Title
Guided Creeping Technique (GCT) in Treating Gingival Recession
Official Title
Guided Creeping Technique (GCT) as a Novel Minimally Invasive Approach in Treating Gingival Recession - Single Arm Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Minimally Invasive Surgery, Tunneling Techniques, Gingival Recession, Creeping Attachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided Creeping Technique (GCT)
Arm Type
Experimental
Arm Description
Novel minimally invasive guided creeping technique
Intervention Type
Procedure
Intervention Name(s)
Guided Creeping Technique (GCT)
Intervention Description
Guided Creeping Technique (GCT) is a novel minimally invasive blind tunnel
Primary Outcome Measure Information:
Title
Recession Coverage
Description
Measured in mm
Time Frame
Change from baseline to 6 months
Secondary Outcome Measure Information:
Title
Keratinized Tissue Width
Description
Measured in mm
Time Frame
Change from baseline to 6 months
Title
Keratinized Tissue Thickness
Description
Measured in mm
Time Frame
Change from baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Patient Reported Outcome
Description
Visual Analog Scale (VAS)
Time Frame
Through 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Y Gamal, Professor
Organizational Affiliation
Faculty of Dentistry, October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 University
City
Giza
ZIP/Postal Code
1211
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Guided Creeping Technique (GCT) in Treating Gingival Recession
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