Pinhole Versus Tunnel for Soft Tissue Recession

Study Overview
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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.

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.

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

Conditions
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Gingival Recession

Intervention / Treatment
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* Procedure: Pinhole surgical technique and tunnel technique in a split mouth design


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pinhole/Tunnel<br>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<br>* 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).<br>|

What is the study measuring?
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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 |