Clinical trial NCT04356391: Pinhole Surgical Technique Compared to Connective Tissue Graft in Treatment of Gingival Recession
Official title: Efficacy of Pinhole Gum Rejuvenation Compared to Connective Tissue Graft in Treatment of Gingival Recession
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Gingival Recession
Marginal Gingiva
Root Coverage
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Geistlich Pharma AG
First posted: 2020-04-22
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, split-mouth, double blinded design clinical trial.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in (Complete root coverage determined by recession classification, percentage root coverage, and recession depth, Pain Index, Healing Index) is being assessed.
timeFrame: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
measure: Change in percentage root coverage is being assessed
timeFrame: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
measure: recession depth
timeFrame: 2 weeks preoperative
measure: Change in Pain Index is being assessed
timeFrame: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
measure: Change in Healing Index is being assessed
timeFrame: Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months
Secondary outcomes:
measure: Change in periodontal parameters (clinical attachment level) is being assessed
timeFrame: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative
measure: change in periodontal parameters (probing depth) is being assessed
timeFrame: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative
measure: change in periodontal parameters (width of keratinized tissue) is being assessed.
timeFrame: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative
measure: Change in periodontal parameters (gingival thickness) is being assessed.
timeFrame: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative
measure: Change in periodontal parameters (gingival index) is being assessed.
timeFrame: baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: 250 Squire Hall, Department of Periodontics, University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Othman Shibly, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University at Buffalo
name: Yahya Sayed Suliman Atassi, BDS
role: STUDY_DIRECTOR
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