Pinhole Versus Tunnel for Soft Tissue Recession

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: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Pinhole surgical technique and tunnel technique in a split mouth design

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 (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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

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

Outcome Measure	Measure Description	Time Frame
Change in gingival thickness	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	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	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	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	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.	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	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.	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	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	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

• Sponsor: Mohanad Al-Sabbagh
• Investigators: Principal Investigator: Mohanad Al-Sabbagh, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): August 6, 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): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession
• 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
• product manufactured in and exported from the U.S.: No