CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Connective Tissue Graft Technique +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04356391
NCT04356391N/ACompleted

Efficacy of Pinhole Gum Rejuvenation Compared to Connective Tissue Graft in Treatment of Gingival Recession

State University of New York at Buffalo·interventional·Posted Apr 22, 2020·Updated May 25, 2023

In Brief

A clinical study evaluating Connective Tissue Graft Technique and Pinhole Surgical Technique for Periodontal Diseases. Completed, enrolled 43 participants across 1 site.

Detailed Summary

This study compares the efficacy of root coverage achieved by the Pinhole Surgical Technique (PST) technique and the Connective Tissue Graft (CTG) technique in the treatment of Miller class I and II gingival recession defects. All patients will receive PST in one quadrant and CTG in another quadrant. The hypothesis being tested is: Pinhole Surgical Technique outcomes are not inferior to those of the Connective Tissue Graft surgical technique.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGeistlich Pharma AG

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 22, 2020
Enrollment StartJan 24, 2018
Primary CompletionAug 2, 2022
Study CompletionApr 26, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.2 years ago

Interventions

Connective Tissue Graft Techniqueprocedure

For the sites receiving the control technique (Connective Tissue Graft), the technique described by Langer B. and Langer L. will be started with a sulcular incision followed by a partial thickness flap. A CTG is then harvested according to the technique described by Bruno, the first incision is perpendicular to the 2nd premolar and 1st molar and is 2-3mm apical to their gingival margin as wide as the recipient site, followed by a second incision parallel to the for mentioned teeth, 1-2mm apical to the first incision, then the CTG is raised by periosteal elevator and released from apical and lateral attachments by sharp incision when needed. The graft is then prepared to have a homogenous thickness of 1.5-2mm. The donor CTG is stabilized to the underlying connective tissue interproximally using 4-0 Vicryl sutures. The recipient flap is repositioned coronally, to cover as much as possible of the graft with no tension, 2mm coronal to the CEJ, then sutured with 4-0 Vicryl sutures.

Pinhole Surgical Techniqueprocedure

For the sites receiving the test technique (Chao Pinhole Surgical Technique) the surgery starts with a small pinhole opening in the alveolar mucosa apical to the mucogingival junction of the affected tooth, the flap is then undermined using special instruments to create a full thickness pouch, followed by extending the pouch horizontally and coronally to undermined the adjacent papilla without incising it and free the flap for its coronal displacement. Then multiple 2x12mm strips of collagen resorbable membrane material (Bio-Gide, Geistlich Pharma AG) are packed under the papilla to secure the flap in a coronal direction. Gentle pressure is applied for 5 minutes to minimize the thickness of the blood clot after each of the procedures. The patients are advised to brush all teeth and sites except the buccal surfaces of the operated-on teeth, which are to be cleaned with 0.12% Chlorhexidine mouth rinse.