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

NCT04356391 | Completed DMC

• 1 other identifier: STUDY00001141
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

Gingival Recession; Marginal Gingiva; Root Coverage

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Change in periodontal parameters (clinical attachment level) is being assessed

  baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

• change in periodontal parameters (probing depth) is being assessed

  baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

• change in periodontal parameters (width of keratinized tissue) is being assessed.

  baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

• Change in periodontal parameters (gingival thickness) is being assessed.

  baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

• Change in periodontal parameters (gingival index) is being assessed.

  baseline, 6 weeks, 3, 6, 12, 18, and 24 months postoperative

Study Arms (2)

Connective Tissue Graft harvest from Palate

ACTIVE COMPARATOR

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

collagen resorbable membrane material

EXPERIMENTAL

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

Interventions

Connective Tissue Graft Technique PROCEDURE

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.

Also known as: Graft Harvested from the Palate

Connective Tissue Graft harvest from Palate

Pinhole Surgical Technique PROCEDURE

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.

Also known as: Collagen Resorbable Membrane Material

collagen resorbable membrane material

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Geistlich Pharma AG: collaborator

Study Sites (1)

250 Squire Hall, Department of Periodontics, University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (22)

• Miller PD Jr. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.

  PMID: 3858267 BACKGROUND

• Albandar JM, Kingman A. Gingival recession, gingival bleeding, and dental calculus in adults 30 years of age and older in the United States, 1988-1994. J Periodontol. 1999 Jan;70(1):30-43. doi: 10.1902/jop.1999.70.1.30.

  PMID: 10052768 BACKGROUND

• Greenwell H, Fiorellini J, Giannobile W, Offenbacher S, Salkin L, Townsend C, Sheridan P, Genco R; Research, Science and Therapy Committee. Oral reconstructive and corrective considerations in periodontal therapy. J Periodontol. 2005 Sep;76(9):1588-600. doi: 10.1902/jop.2005.76.9.1588.

  PMID: 16171452 BACKGROUND

• Langer L, Langer B. The subepithelial connective tissue graft for treatment of gingival recession. Dent Clin North Am. 1993 Apr;37(2):243-64.

  PMID: 8477867 BACKGROUND

• Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.

  PMID: 3866056 BACKGROUND

• Miller PD Jr. Root coverage using a free soft tissue autograft following citric acid application. Part 1: Technique. Int J Periodontics Restorative Dent. 1982;2(1):65-70. No abstract available.

  PMID: 6959974 BACKGROUND

• Holbrook T, Ochsenbein C. Complete coverage of the denuded root surface with a one-stage gingival graft. Int J Periodontics Restorative Dent. 1983;3(3):8-27. No abstract available.

  PMID: 6358084 BACKGROUND

• Grupe HE, Warren RF. Repair of Gingival Defects by a Sliding Flap Operation. Journal of periodontology 1956;27:92-95.

  BACKGROUND

• Pfeifer JS, Heller R. Histologic evaluation of full and partial thickness lateral repositioned flaps: a pilot study. J Periodontol. 1971 Jun;42(6):331-3. doi: 10.1902/jop.1971.42.6.331. No abstract available.

  PMID: 5282573 BACKGROUND

• Cohen DW, Ross SE. The double papillae repositioned flap in periodontal therapy. J Periodontol. 1968 Mar;39(2):65-70. doi: 10.1902/jop.1968.39.2.65. No abstract available.

  PMID: 4870433 BACKGROUND

• Ross SE, Crosetti HW, Gargiulo A, Cohen DW. The double papillae repositioned flap--an alternative. I. Fourteen years in retrospect. Int J Periodontics Restorative Dent. 1986;6(6):46-59. No abstract available.

  PMID: 3468092 BACKGROUND

• Bernimoulin JP, Luscher B, Muhlemann HR. Coronally repositioned periodontal flap. Clinical evaluation after one year. J Clin Periodontol. 1975 Feb;2(1):1-13. doi: 10.1111/j.1600-051x.1975.tb01721.x.

  PMID: 1055724 BACKGROUND

• Allen EP, Miller PD Jr. Coronal positioning of existing gingiva: short term results in the treatment of shallow marginal tissue recession. J Periodontol. 1989 Jun;60(6):316-9. doi: 10.1902/jop.1989.60.6.316.

  PMID: 2778599 BACKGROUND

• Sorrentino JM, Tarnow DP. The semilunar coronally repositioned flap combined with a frenectomy to obtain root coverage over the maxillary central incisors. J Periodontol. 2009 Jun;80(6):1013-7. doi: 10.1902/jop.2009.080553.

  PMID: 19485834 BACKGROUND

• Tarnow DP. Semilunar coronally repositioned flap. J Clin Periodontol. 1986 Mar;13(3):182-5. doi: 10.1111/j.1600-051x.1986.tb01456.x.

  PMID: 3457805 BACKGROUND

• Maynard JG Jr. Coronal positioning of a previously placed autogenous gingival graft. J Periodontol. 1977 Mar;48(3):151-5. doi: 10.1902/jop.1977.48.3.151.

  PMID: 264963 BACKGROUND

• Al-Hamdan K, Eber R, Sarment D, Kowalski C, Wang HL. Guided tissue regeneration-based root coverage: meta-analysis. J Periodontol. 2003 Oct;74(10):1520-33. doi: 10.1902/jop.2003.74.10.1520.

  PMID: 14653400 BACKGROUND

• Harris RJ. A comparative study of root coverage obtained with an acellular dermal matrix versus a connective tissue graft: results of 107 recession defects in 50 consecutively treated patients. Int J Periodontics Restorative Dent. 2000 Feb;20(1):51-9.

  PMID: 11203548 BACKGROUND

• Chambrone L, Tatakis DN. Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S8-51. doi: 10.1902/jop.2015.130674.

  PMID: 25644302 BACKGROUND

• Chambrone L, Chambrone D, Pustiglioni FE, Chambrone LA, Lima LA. Can subepithelial connective tissue grafts be considered the gold standard procedure in the treatment of Miller Class I and II recession-type defects? J Dent. 2008 Sep;36(9):659-71. doi: 10.1016/j.jdent.2008.05.007. Epub 2008 Jun 26.

  PMID: 18584934 BACKGROUND

• Henderson RD, Greenwell H, Drisko C, Regennitter FJ, Lamb JW, Mehlbauer MJ, Goldsmith LJ, Rebitski G. Predictable multiple site root coverage using an acellular dermal matrix allograft. J Periodontol. 2001 May;72(5):571-82. doi: 10.1902/jop.2001.72.5.571.

  PMID: 11394391 BACKGROUND

• Chao JC. A novel approach to root coverage: the pinhole surgical technique. Int J Periodontics Restorative Dent. 2012 Oct;32(5):521-31.

  PMID: 22754900 RESULT

MeSH Terms

Conditions

Periodontal Diseases; Gingival Recession

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Periodontal Atrophy

Study Officials

• Othman Shibly, DDS

  University at Buffalo

  PRINCIPAL INVESTIGATOR

• Yahya Sayed Suliman Atassi, BDS

  University at Buffalo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director of the Advanced Education Program in Periodontics

Model Details: Randomized, split-mouth, double blinded design clinical trial.

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: April 22, 2020
• Study Start: January 24, 2018
• Primary Completion: August 2, 2022
• Study Completion: April 26, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)