Pinhole Versus Tunnel for Soft Tissue Recession

Gingival Recession Clinical Trial

Official title:

Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04513041
• Other study ID #: 80275
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: Mohanad Al-Sabbagh
• Phone: 8592573003
• Email: malsa2[@]email.uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession

Intervention

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).

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Mohanad Al-Sabbagh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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