- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04513041
Pinhole Versus Tunnel for Soft Tissue Recession
June 28, 2023 updated by: Mohanad Al-Sabbagh
Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohanad Al-Sabbagh
- Phone Number: 8592573003
- Email: malsa2@email.uky.edu
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky
-
Contact:
- Ruta Panyik, manager
- Phone Number: 859-562-2622
- Email: r.valinskaite@uky.edu
-
Contact:
- Mohanad Al-Sabbagh, BDS (DDS)
- Phone Number: 859-257-3003
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pinhole/Tunnel
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gingival thickness
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival thickness.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Change in gingival recession
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the change in gingival recession.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in papillary recession
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure papillary gingival recession.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Change in root coverage
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
Two digital scans (pre- and 6-month post-operative) will be overlapped to measure the complete elimination of gingival recession.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Change in sulcus probing depth
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
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.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Change in clinical attachment.
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
Clinical attachment will be calculated during the pre- and post-operative clinical exam.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Change in zone of keratinized tissue
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
During a clinical exam, the zone of keratinized tissue will be measured during the pre- and post-operative clinical exam.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Change in bleeding on probing.
Time Frame: 6 months (pre operative and at the 6-month follow-up visit)
|
The presence or absense of bleeding during probing during will be noted during the pre- and post-operative clinical exam.
|
6 months (pre operative and at the 6-month follow-up visit)
|
Post-operative pain
Time Frame: 1 week
|
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.
|
1 week
|
Aesthetic satisfaction
Time Frame: 1 day
|
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.
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohanad Al-Sabbagh, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2020
Primary Completion (Estimated)
March 30, 2024
Study Completion (Estimated)
March 30, 2024
Study Registration Dates
First Submitted
July 29, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (Actual)
August 14, 2020
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 80275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participants data will not be shared, rather the accumulated data for all participants could be shared to eliminate identification of participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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