Pinhole Versus Tunnel for Soft Tissue Recession

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-25

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gingival Recession

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

PI and statistician will be blinded to the type of investigation for

Study Groups

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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

Group Type EXPERIMENTAL

Pinhole surgical technique and tunnel technique in a split mouth design

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes