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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention 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
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
PI and statistician will be blinded to the type of investigation for

Arm Groups

ArmDescriptionAssigned Intervention
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).

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Mohanad Al-Sabbagh, BDS (DDS)
859-257-3003

More Details

NCT ID
NCT04513041
Status
Recruiting
Sponsor
Mohanad Al-Sabbagh

Study Contact

Mohanad Al-Sabbagh
8592573003
malsa2@email.uky.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.