The Efficacy of De-epithelialized Free Gingival Graft on Treatment of Multiple Gingival Recessions With Tunnel Technique

NCT04291963 | Completed DMC

• 1 other identifier: 36290600/110
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The predictable treatment of multiple adjacent gingival recessions (MAGRs) represents a major challenge in periodontal plastic surgeries due to MAGRs' complicated predisposing anatomic features, such as thin gingival phenotype or limited keratinized tissue. The present study aimed to investigate the clinical efficacy and postoperative morbidity of de-epithelialized gingival graft (DGG) compared to subepithelial connective tissue graft (SCTG) on the treatment of multiple adjacent gingival recessions (MAGRs) with tunnel technique (TUN). A total of 38 patients, who have been referred to the Gazi University Faculty of Dentistry Department of Periodontology, were randomly assigned to receive TUN in combination with either DGG or SCTG. Clinical measurements were recorded at baseline and at 3, 6 and 12 months after surgeries. Immediately after surgery, a questionnaire was given to each patient evaluating postoperative pain, patients' discomfort, sensitivity and bleeding at 1, 2, 3, 7, 14 and 28 days after surgery. Moreover, the characteristics of the grafts harvested by these two different techniques were evaluated histopathologically and histomorphometrically.

Conditions

Gingival Recession

Keywords

gingival recessions; connective tissue graft; de-epithelialized gingival graft; tunnel technique

Outcome Measures

Primary Outcomes (1)

• Root coverage outcomes

  Mean root coverage of DGG versus SCTG with TUN

  1-year postoperatively

Secondary Outcomes (6)

• Root coverage outcomes

  1-year postoperatively

• Root coverage outcomes

  1-year postoperatively

• patient morbidity

  up to 28 days postoperatively

• patient morbidity

  up to 28 days postoperatively

• histopathological features of the graft

  through study completion, an average of 1 year

Study Arms (2)

DGG + TUN

ACTIVE COMPARATOR

The multiple adjacent gingival recession sites were treated with DGG in conjunction with TUN technique.

Procedure: DGG + TUN

SCTG + TUN

ACTIVE COMPARATOR

The multiple adjacent gingival recession sites were treated with SCTG in conjunction with TUN technique.

Procedure: SCTG + TUN

Interventions

DGG + TUN PROCEDURE

In the DGG group, CTG was obtained at palatal mucosa by means of intra-oral de-epithelialization of the FGG using a 2.3 mm diameter diamond burr (801G/023, EMS, Aldrich Co., USA) with NaCL 0.9% saline irrigation

DGG + TUN

SCTG + TUN PROCEDURE

In SCTG group, graft was harvested through the single-incision approach at palatal mucosa

SCTG + TUN

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 - 60 years,
• Non-smoker and systemically healthy,
• No active periodontal disease,
• Presence of at least two single-rooted teeth with Miller class I and/or II (RT1) (Cairo, Nieri, Cincinelli, Mervelt, \& Pagliaro, 2011; Miller, 1985) buccal gingival recession defects ≥2 mm in depth
• Full mouth plaque and bleeding score of \<15% and no probing depths \>3 mm,
• Absence of non-carious cervical lesions (NCCLs) and non-detectable cemento-enamel junction (CEJ) at the defect sites,
• No history of previous periodontal plastic surgery at the affected sites.

You may not qualify if:

• Presence of caries lesions or restorations in the cervical area,
• Intake of medications which impede periodontal tissue health and healing,
• Medical contraindications for periodontal surgical procedures,
• Pregnancy and lactation.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Sila Isler

Ankara, 06510, Turkey (Türkiye)

Location

Related Publications (23)

• Aroca S, Barbieri A, Clementini M, Renouard F, de Sanctis M. Treatment of class III multiple gingival recessions: Prognostic factors for achieving a complete root coverage. J Clin Periodontol. 2018 Jul;45(7):861-868. doi: 10.1111/jcpe.12923. Epub 2018 Jun 15.

  PMID: 29757468 RESULT

• Sculean A, Cosgarea R, Stahli A, Katsaros C, Arweiler NB, Miron RJ, Deppe H. Treatment of multiple adjacent maxillary Miller Class I, II, and III gingival recessions with the modified coronally advanced tunnel, enamel matrix derivative, and subepithelial connective tissue graft: A report of 12 cases. Quintessence Int. 2016;47(8):653-9. doi: 10.3290/j.qi.a36562.

  PMID: 27446995 RESULT

• Tatakis DN, Chambrone L, Allen EP, Langer B, McGuire MK, Richardson CR, Zabalegui I, Zadeh HH. Periodontal soft tissue root coverage procedures: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S52-5. doi: 10.1902/jop.2015.140376. Epub 2014 Oct 15.

  PMID: 25315018 RESULT

• Tavelli L, Barootchi S, Nguyen TVN, Tattan M, Ravida A, Wang HL. Efficacy of tunnel technique in the treatment of localized and multiple gingival recessions: A systematic review and meta-analysis. J Periodontol. 2018 Sep;89(9):1075-1090. doi: 10.1002/JPER.18-0066. Epub 2018 Aug 13.

  PMID: 29761502 RESULT

• Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.

  PMID: 23627374 RESULT

• 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 RESULT

• Buti J, Baccini M, Nieri M, La Marca M, Pini-Prato GP. Bayesian network meta-analysis of root coverage procedures: ranking efficacy and identification of best treatment. J Clin Periodontol. 2013 Apr;40(4):372-86. doi: 10.1111/jcpe.12028. Epub 2013 Jan 24.

  PMID: 23346965 RESULT

• Zucchelli G, Mele M, Stefanini M, Mazzotti C, Marzadori M, Montebugnoli L, de Sanctis M. Patient morbidity and root coverage outcome after subepithelial connective tissue and de-epithelialized grafts: a comparative randomized-controlled clinical trial. J Clin Periodontol. 2010 Aug 1;37(8):728-38. doi: 10.1111/j.1600-051X.2010.01550.x. Epub 2010 Jun 24.

  PMID: 20590963 RESULT

• Harris RJ. A comparison of two techniques for obtaining a connective tissue graft from the palate. Int J Periodontics Restorative Dent. 1997 Jun;17(3):260-71.

  PMID: 9497718 RESULT

• Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.

  PMID: 7928129 RESULT

• Hurzeler MB, Weng D. A single-incision technique to harvest subepithelial connective tissue grafts from the palate. Int J Periodontics Restorative Dent. 1999 Jun;19(3):279-87.

  PMID: 10635174 RESULT

• Lorenzana ER, Allen EP. The single-incision palatal harvest technique: a strategy for esthetics and patient comfort. Int J Periodontics Restorative Dent. 2000 Jun;20(3):297-305.

  PMID: 11203571 RESULT

• Griffin TJ, Cheung WS, Zavras AI, Damoulis PD. Postoperative complications following gingival augmentation procedures. J Periodontol. 2006 Dec;77(12):2070-9. doi: 10.1902/jop.2006.050296.

  PMID: 17209793 RESULT

• Gobbato L, Nart J, Bressan E, Mazzocco F, Paniz G, Lops D. Patient morbidity and root coverage outcomes after the application of a subepithelial connective tissue graft in combination with a coronally advanced flap or via a tunneling technique: a randomized controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):2191-2202. doi: 10.1007/s00784-016-1721-7. Epub 2016 Jan 27.

  PMID: 26814715 RESULT

• Isler SC, Eraydin N, Akkale H, Ozdemir B. Oral flurbiprofen spray for mucosal graft harvesting at the palatal area: A randomized placebo-controlled study. J Periodontol. 2018 Oct;89(10):1174-1183. doi: 10.1002/JPER.17-0381. Epub 2018 Aug 29.

  PMID: 30007054 RESULT

• Harris RJ. Root coverage in molar recession: report of 50 consecutive cases treated with subepithelial connective tissue grafts. J Periodontol. 2003 May;74(5):703-8. doi: 10.1902/jop.2003.74.5.703.

  PMID: 12816304 RESULT

• Bosco AF, Bosco JM. An alternative technique to the harvesting of a connective tissue graft from a thin palate: enhanced wound healing. Int J Periodontics Restorative Dent. 2007 Apr;27(2):133-9.

  PMID: 17514885 RESULT

• de Sanctis M, Baldini N, Goracci C, Zucchelli G. Coronally advanced flap associated with a connective tissue graft for the treatment of multiple recession defects in mandibular posterior teeth. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):623-30.

  PMID: 22140664 RESULT

• Zuhr O, Baumer D, Hurzeler M. The addition of soft tissue replacement grafts in plastic periodontal and implant surgery: critical elements in design and execution. J Clin Periodontol. 2014 Apr;41 Suppl 15:S123-42. doi: 10.1111/jcpe.12185.

  PMID: 24640997 RESULT

• Azar EL, Rojas MA, Patricia M, Carranza N. Histologic and Histomorphometric Analyses of De-epithelialized Free Gingival Graft in Humans. Int J Periodontics Restorative Dent. 2019 Mar/Apr;39(2):221-226. doi: 10.11607/prd.3544.

  PMID: 30794258 RESULT

• Bertl K, Pifl M, Hirtler L, Rendl B, Nurnberger S, Stavropoulos A, Ulm C. Relative Composition of Fibrous Connective and Fatty/Glandular Tissue in Connective Tissue Grafts Depends on the Harvesting Technique but not the Donor Site of the Hard Palate. J Periodontol. 2015 Dec;86(12):1331-9. doi: 10.1902/jop.2015.150346. Epub 2015 Aug 20.

  PMID: 26291293 RESULT

• Tavelli L, Barootchi S, Namazi SS, Chan HL, Brzezinski D, Danciu T, Wang HL. The influence of palatal harvesting technique on the donor site vascular injury: A split-mouth comparative cadaver study. J Periodontol. 2020 Jan;91(1):83-92. doi: 10.1002/JPER.19-0073. Epub 2019 Aug 18.

  PMID: 31376154 RESULT

• McLeod DE, Reyes E, Branch-Mays G. Treatment of multiple areas of gingival recession using a simple harvesting technique for autogenous connective tissue graft. J Periodontol. 2009 Oct;80(10):1680-7. doi: 10.1902/jop.2009.090187.

  PMID: 19792859 RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Burcu C Ozdemir, Assoc Prof

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 2, 2020
• Study Start: December 9, 2017
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)