Clinical trial NCT04513041: Pinhole Versus Tunnel for Soft Tissue Recession
Official title: Comparison of Pinhole Surgical Technique and Tunnel Technique for the Treatment of Gingival Recession: A Split Mouth Clinical and Digital Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in gingival thickness
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
measure: Change in gingival recession
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
Secondary outcomes:
measure: Change in papillary recession
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
measure: Change in root coverage
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
measure: Change in sulcus probing depth
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
measure: Change in clinical attachment.
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
measure: Change in zone of keratinized tissue
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
measure: Change in bleeding on probing.
timeFrame: 6 months (pre operative and at the 6-month follow-up visit)
measure: Post-operative pain
timeFrame: 1 week
measure: Aesthetic satisfaction
timeFrame: 1 day
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Mohanad Al-Sabbagh
role: PRINCIPAL_INVESTIGATOR
References: