Pinhole Versus Tunnel for Soft Tissue Recession

February 11, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Procedure: Pinhole surgical technique and tunnel technique in a split mouth design
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mohanad Al-Sabbagh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Gingival Recession

Clinical Trials on Pinhole surgical technique and tunnel technique in a split mouth design

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings