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

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

Study Locations

    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Contact:
        • 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.

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

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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