Pinhole Versus Tunnel for Soft Tissue Recession
Primary Purpose
Gingival Recession
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pinhole surgical technique and tunnel technique in a split mouth design
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession
Eligibility Criteria
Inclusion Criteria:
- between 18-75 years old
- have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.
- American Society of Anesthesiology class I and II
- full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%
Exclusion Criteria:
- sites of gingival recession around teeth that are non-salvageable
- presence of any exudate, infection or local inflammation around the area to be grafted
- pregnant or breastfeeding females
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pinhole/Tunnel
Arm Description
Participants will receive Pinhole surgical technique for treatment of soft tissue recession at one side of the mouth and Tunnel technique for treatment of soft tissue recession at the other side of the mouth
Outcomes
Primary Outcome Measures
Change in gingival thickness
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness.
Change in gingival recession
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession.
Secondary Outcome Measures
Change in papillary recession
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure papillary gingival recession.
Change in root coverage
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the complete elimination of gingival recession.
Change in sulcus probing depth
During a clinical exam, a sulcus will be used to measure the depth from the free gingival margin to the base of the sulcus pre- and 6-months post-operative.
Change in clinical attachment.
Clinical attachment will be calculated during the pre- and post-operative clinical exam.
Change in zone of keratinized tissue
During a clinical exam, the zone of keratinized tissue will be measured during the pre- and post-operative clinical exam.
Change in bleeding on probing.
The presence or absense of bleeding during probing during will be noted during the pre- and post-operative clinical exam.
Post-operative pain
A Visual Analog Score for pain will be used to assess post-operative pain one week after surgery. Scores range from 0-10; higher scores indicate greater pain.
Aesthetic satisfaction
A Visual Analog Score for aesthetic satisfaction will be used to assess patient satisfaction 6 months after surgery. Scores range from 0-10; higher scores indicate greater satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04513041
Brief Title
Pinhole Versus Tunnel for Soft Tissue Recession
Official Title
Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohanad Al-Sabbagh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique.
Detailed Description
Each patient will undergo both surgeries on either quadrant; the PST and tunnel technique. The site will be randomized to receive either type of surgeries. Both types of surgeries are considered minimally invasive procedures to obtain root coverage for gingival recession. Both surgeries are clinically utilized in clinical practice and yield comparable results according to the literature, however, No prospective studies are published to compare between the outcomes of both techniques. patients will receive intra oral scan before the surgery and 6 months after the surgery to compare change in root coverage and gingival thickness outcomes between the two techniques. Post operative pain as well as patient satisfaction will be measured by visual analog scale and compared between the two techniques. Patients will be monitored at different time points to asses healing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Right and left sides of the mouth will be randomly assigned to test and control group by computer generated randomization table in a split mouth design
Masking
None (Open Label)
Masking Description
PI and statistician will be blinded to the type of investigation for
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pinhole/Tunnel
Arm Type
Experimental
Arm Description
Participants will receive Pinhole surgical technique for treatment of soft tissue recession at one side of the mouth and Tunnel technique for treatment of soft tissue recession at the other side of the mouth
Intervention Type
Procedure
Intervention Name(s)
Pinhole surgical technique and tunnel technique in a split mouth design
Intervention Description
Each subject will have the each surgical procedure which are both considered routine minimally invasive clinical care for gingival recession. Gum recession on one side will receive Pinhole surgical technique (test procedure). The other side will receive Tunnel technique (control procedure), Research component involved is the capture of digital impression using intra-oral scanner in the baseline (preoperative) and the final visit (6 months postoperative).
Primary Outcome Measure Information:
Title
Change in gingival thickness
Description
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Title
Change in gingival recession
Description
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Secondary Outcome Measure Information:
Title
Change in papillary recession
Description
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure papillary gingival recession.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Title
Change in root coverage
Description
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the complete elimination of gingival recession.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Title
Change in sulcus probing depth
Description
During a clinical exam, a sulcus will be used to measure the depth from the free gingival margin to the base of the sulcus pre- and 6-months post-operative.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Title
Change in clinical attachment.
Description
Clinical attachment will be calculated during the pre- and post-operative clinical exam.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Title
Change in zone of keratinized tissue
Description
During a clinical exam, the zone of keratinized tissue will be measured during the pre- and post-operative clinical exam.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Title
Change in bleeding on probing.
Description
The presence or absense of bleeding during probing during will be noted during the pre- and post-operative clinical exam.
Time Frame
6 months (pre operative and at the 6-month follow-up visit)
Title
Post-operative pain
Description
A Visual Analog Score for pain will be used to assess post-operative pain one week after surgery. Scores range from 0-10; higher scores indicate greater pain.
Time Frame
1 week
Title
Aesthetic satisfaction
Description
A Visual Analog Score for aesthetic satisfaction will be used to assess patient satisfaction 6 months after surgery. Scores range from 0-10; higher scores indicate greater satisfaction.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
between 18-75 years old
have at least one non-mobile tooth with Cairo class I gingival recession of 2 to 6 mm.
American Society of Anesthesiology class I and II
full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) below 20%
Exclusion Criteria:
sites of gingival recession around teeth that are non-salvageable
presence of any exudate, infection or local inflammation around the area to be grafted
pregnant or breastfeeding females
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohanad Al-Sabbagh
Phone
8592573003
Email
malsa2@email.uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohanad Al-Sabbagh
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohanad Al-Sabbagh, BDS (DDS)
Phone
859-257-3003
First Name & Middle Initial & Last Name & Degree
Ruta Panyik, manager
Phone
859-562-2622
Email
r.valinskaite@uky.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participants data will not be shared, rather the accumulated data for all participants could be shared to eliminate identification of participants.
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Pinhole Versus Tunnel for Soft Tissue Recession
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