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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: Connective Tissue Graft Technique
* Procedure: Pinhole Surgical Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients should be above 18 years old. The presence of Miller's class I or II gingival recession on at least two matching bilateral or contralateral gingival recession defects (≥ 2 mm). Recession defect on maxillary incisors, maxillary and mandibular canines, or premolars. Absence of a history of periodontal surgery at the involved sites in the last 12 months. History of compliance with oral hygiene instructions and periodontal recall. Sufficient palatal or tuberosity donor tissue thickness (> 2mm). Exclusion Criteria: Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc. Pregnant and lactating women History of allergic reactions to drugs or materials used in the surgery including collagen. Current use of any form of tobacco.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, split-mouth, double blinded design clinical trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective Tissue Graft harvest from Palate<br>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. | Procedure: Connective Tissue Graft Technique<br>* 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.<br>* Other names: Graft Harvested from the Palate;|
| Experimental: collagen resorbable membrane material<br>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. | Procedure: Pinhole Surgical Technique<br>* 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.<br>* Other names: Collagen Resorbable Membrane Material;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in (Complete root coverage determined by recession classification, percentage root coverage, and recession depth, Pain Index, Healing Index) is being assessed. | Complete root coverage (CRC): The number of sites that resulted in 100% root coverage. | Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months | 
| Change in percentage root coverage is being assessed | Percentage root coverage (%RC): calculated as ([RD preoperative - RD postoperative]/RD preoperative) × 100%. | Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months | 
| recession depth | Recession Depth (RD): Measured in millimeters from the gingival margin at the mid-buccal aspect of the root, to the Cemento-Enamel Junction (CEJ) or relative CEJ. | 2 weeks preoperative | 
| Change in Pain Index is being assessed | Pain index (PN): Pain is recorded on a horizontal pain scale of 0-10. Pain index as follows; Mild for ''0 to 3,'' moderate for ''4 to 6,'' and severe for ''7 to 10.'' | Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months | 
| Change in Healing Index is being assessed | Healing index (HI): A horizontal scale from 1-5 evaluating tissue color, response to palpation, granulation tissue, incision margin, suppuration, adopted from Aleksic. 1 (very poor). 2 (poor). 3 (good). 4 (very good). | Postoperative: baseline, 6 weeks, 3, 6, 12, 18, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in periodontal parameters (clinical attachment level) is being assessed | Clinical attachment level (CAL): Measured in millimeters from CEJ or relative CEJ to the base of the periodontal sulcus at 6 sites per tooth. | baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative | 
| change in periodontal parameters (probing depth) is being assessed | Probing depth (PD): Measured in millimeters from the gingival margin to the base of the periodontal sulcus at 6 sites per tooth. | baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative | 
| change in periodontal parameters (width of keratinized tissue) is being assessed. | Width of the keratinized tissue (KTW): Measured in millimeters at mid-buccal aspect of the tooth from the gingival margin to the mucogingival junction. | baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative | 
| Change in periodontal parameters (gingival thickness) is being assessed. | Gingival Thickness: Measured in millimeters at the mid-buccal of the gingiva and 2 mm apical the gingival margin at the attached gingiva or the alveolar mucosa using a #15 endodontic reamer with a silicon disk stop. | baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative | 
| Change in periodontal parameters (gingival index) is being assessed. | Gingival index (GI): GI is measured according to Loe and Sillness and scored on a scale of 0 to 3. | baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marginal Gingiva, Root Coverage, Gingival Recession