Pinhole Surgical Technique Compared to Connective Tissue Graft in Treatment of Gingival Recession

University at Buffalo (UB)

Status: Completed

Conditions: Periodontal Diseases

Treatments: Procedure: Pinhole Surgical Technique; Procedure: Connective Tissue Graft Technique

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04356391

STUDY00001141

Details and patient eligibility

About

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.

Full description

Gingival recession is defined as the apical migration of the marginal gingiva and it leads to root surface exposure. It may be localized to a few sites or generalized to several teeth, and the severity may vary within the same person and between different people.

A variety of surgical techniques have been recommended to attain root coverage, including connective tissue graft, free gingival graft (FGG), pedicle flaps, double papilla grafts, coronally positioned flaps, coronal positioning of previously placed FGG, guided tissue regeneration (GTR), and the use of acellular dermal matrix (ADM), or enamel matrix derivatives. A recently developed technique used to attain root coverage is the Pinhole Surgical Technique (PST) described by Chao. This novel approach involves the separation of the gingiva and periosteum from the underlying bone with instruments inserted through a pinhole created in the vestibular area of the involved tooth while filling underneath the undermined interproximal papilla with strips of a bioresorbable membrane, rather than transferring gingival tissue from the palate to the area of recession. The advantage of this technique is the preservation of the gingival tissues and its blood supply, while freeing the flap from its apical attachment for ease of coronal displacement and adequate root coverage. In addition, the lack of a secondary surgical site may eliminate the accompanying pain and discomfort often reported in root coverage procedures.

The connective tissue graft technique was described by Langer and Langer in 1985, in which the patient's own connective tissue is taken mostly from the palate and used to cover the area of recession. The retro-molar pad area (tuberosity) has also been used because of the thickening of the sub-mucosa in that area. This graft material is carefully sutured into place and a coronally advanced flap placed and sutured over it, while part of the graft can be left exposed. Currently the connective tissue graft (CTG) is the most common and predictable treatment for gingival recession, and is considered the gold standard. Key advantages of the connective tissue graft procedure are the availability of two sources of blood supply to the graft: one from the recipient bed, and the other from the overlying flap, the perfect chromatic integration, an optimal esthetic outcome, and excellent color match. In addition, an increase in the thickness of the gingival tissues and the width of keratinized gingiva has been documented with the ability for creeping attachment which is not possible with the use of bioresorbable collagen membranes.

Enrollment: 43 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patients should be above 18 years old.
2. The presence of Miller's class I or II gingival recession on at least two matching bilateral or contralateral gingival recession defects (≥ 2 mm).
3. Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars.
4. Absence of a history of periodontal surgery at the involved sites in the last 12 months.
5. History of compliance with oral hygiene instructions and periodontal recall.
6. Sufficient palatal or tuberosity donor tissue thickness (> 2mm).

Exclusion criteria

1. Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.
2. Pregnant and lactating women
3. History of allergic reactions to drugs or materials used in the surgery including collagen.
4. Current use of any form of tobacco.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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43 participants in 2 patient groups

Connective Tissue Graft harvest from Palate

Active Comparator group

Description:

In each participant, a tooth will be assigned to the Connective Tissue Graft (CTG) technique and another tooth to the Pinhole Technique. The tooth assigned to the CTG technique will receive the graft harvested from the palate.

Treatment:

Procedure: Connective Tissue Graft Technique

collagen resorbable membrane material

Experimental group

Description:

In each participant, a tooth will be assigned to the Connective Tissue Graft (CTG) technique and another tooth to the Pinhole Surgical Technique (PST). The tooth assigned to the PST technique will receive the collagen resorbable membrane material.

Treatment:

Procedure: Pinhole Surgical Technique