Pinhole Versus Tunnel for Soft Tissue Recession

NCT04513041 | Completed

• 1 other identifier: 80275
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change in papillary recession

  6 months (pre operative and at the 6-month follow-up visit)

• Change in root coverage

  6 months (pre operative and at the 6-month follow-up visit)

• Change in sulcus probing depth

  6 months (pre operative and at the 6-month follow-up visit)

• Change in clinical attachment.

  6 months (pre operative and at the 6-month follow-up visit)

• Change in zone of keratinized tissue

  6 months (pre operative and at the 6-month follow-up visit)

Study Arms (1)

Pinhole/Tunnel

EXPERIMENTAL

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

Interventions

Pinhole surgical technique and tunnel technique in a split mouth design PROCEDURE

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).

Pinhole/Tunnel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohanad Al-Sabbagh: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Mohanad Al-Sabbagh

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: PI and statistician will be blinded to the type of investigation for
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 14, 2020
• Study Start: June 25, 2020
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)