Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2

NCT03791554 | Completed DMC

• 1 other identifier: Perio2414
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect of tunneling technique with subepithelial connective tissue graft versus tunneling technique with laterally closed tunnel in treatment of recession type 2 defect.Few randomized clinical trial has been involved with recession type 2 defects treated with tunneling technique and coronal advanced flap.

Conditions

Gingival Recession

Keywords

tunneling; laterally closed tunnel; gingival recession; recession type 2

Outcome Measures

Primary Outcomes (1)

• Reduction Recession Depth

  recession depth measured from CEJ to the gingival margin in a cross-section at the central buccal site.

  6 month

Secondary Outcomes (10)

• Gingival recession depth.

  6 month

• Gingival recession width

  6 month

• Root coverage esthetic score (RES)

  6 month

• Probing depth

  6 month

• Clinical attachment level

  6 month

Study Arms (2)

Group A : Lateral closed Tunnel

ACTIVE COMPARATOR

Laterally closed tunnel procedure with subepithelial connective tissue graft (sCTG) After local anesthesia, root planing will be performed. Recession defect - a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. • Recipient site; Using either single or mattress sutures, the graft will be pulled and fixed mesially and distally at the inner aspect of the pouch. The graft will be adapted to the CEJ by means of a sling suture. Margins of the pouch will be pulled together over the graft and sutured with interrupted sutures to accomplish tension-free complete or partial coverage of the graft as well as the denuded root surface.

Procedure: Group A (Lateral closed tunnel subepithelial CT graft)

Group B : Tunneling

ACTIVE COMPARATOR

Tunnel procedure with subepithelial connective tissue graft (sCTG) - Control: At the recipient site (recession defect): a tunneling technique will be prepared using sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact. Then the graft is placed and secured in the recipient site. The flap is displaced to be in a coronal position using a sling suture with no suturing to approximate the margins together.

Procedure: Group B (Tunnel procedure with subepithelial CT graft)

Interventions

Group A (Lateral closed tunnel subepithelial CT graft) PROCEDURE

Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the adjacent teeth to treating gingival recession with edges of the recession sutured together after placing connective tissue graft

Group A : Lateral closed Tunnel

Group B (Tunnel procedure with subepithelial CT graft) PROCEDURE

Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession

Also known as: Autogenous sCTG will be used with tunnel procedure

Group B : Tunneling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older.
• Patients with healthy systemic condition
• Buccal recession defects with recession type 2 defects.
• Clinical indication and/or patient request for recession coverage.
• O'Leary index less than 20%

You may not qualify if:

• Pregnant females.
• Smokers as it is a contraindication for any plastic periodontal surgery
• Unmotivated, uncooperative patients with poor oral hygiene
• Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or para-functional habits.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Almanyal , Cairo, 12613, Egypt

Location

Related Publications (21)

• Agudio G, Nieri M, Rotundo R, Cortellini P, Pini Prato G. Free gingival grafts to increase keratinized tissue: a retrospective long-term evaluation (10 to 25 years) of outcomes. J Periodontol. 2008 Apr;79(4):587-94. doi: 10.1902/jop.2008.070414.

  PMID: 18380550 BACKGROUND

• Aroca S, Keglevich T, Nikolidakis D, Gera I, Nagy K, Azzi R, Etienne D. Treatment of class III multiple gingival recessions: a randomized-clinical trial. J Clin Periodontol. 2010 Jan;37(1):88-97. doi: 10.1111/j.1600-051X.2009.01492.x. Epub 2009 Nov 30.

  PMID: 19968743 BACKGROUND

• Baldi C, Pini-Prato G, Pagliaro U, Nieri M, Saletta D, Muzzi L, Cortellini P. Coronally advanced flap procedure for root coverage. Is flap thickness a relevant predictor to achieve root coverage? A 19-case series. J Periodontol. 1999 Sep;70(9):1077-84. doi: 10.1902/jop.1999.70.9.1077.

  PMID: 10505811 BACKGROUND

• Cairo F, Nieri M, Cincinelli S, Mervelt J, Pagliaro U. The interproximal clinical attachment level to classify gingival recessions and predict root coverage outcomes: an explorative and reliability study. J Clin Periodontol. 2011 Jul;38(7):661-6. doi: 10.1111/j.1600-051X.2011.01732.x. Epub 2011 Apr 20.

  PMID: 21507033 BACKGROUND

• Cairo F, Rotundo R, Miller PD, Pini Prato GP. Root coverage esthetic score: a system to evaluate the esthetic outcome of the treatment of gingival recession through evaluation of clinical cases. J Periodontol. 2009 Apr;80(4):705-10. doi: 10.1902/jop.2009.080565.

  PMID: 19335093 BACKGROUND

• Cortellini P, Tonetti M, Baldi C, Francetti L, Rasperini G, Rotundo R, Nieri M, Franceschi D, Labriola A, Prato GP. Does placement of a connective tissue graft improve the outcomes of coronally advanced flap for coverage of single gingival recessions in upper anterior teeth? A multi-centre, randomized, double-blind, clinical trial. J Clin Periodontol. 2009 Jan;36(1):68-79. doi: 10.1111/j.1600-051X.2008.01346.x. Epub 2008 Nov 20.

  PMID: 19046326 BACKGROUND

• Dominiak M, Gedrange T. New perspectives in the diagnostic of gingival recession. Adv Clin Exp Med. 2014 Nov-Dec;23(6):857-63. doi: 10.17219/acem/27907.

  PMID: 25618109 BACKGROUND

• Edel A. Clinical evaluation of free connective tissue grafts used to increase the width of keratinised gingiva. 1974. Periodontal Clin Investig. 1998 Spring;20(1):12-20. No abstract available.

  PMID: 9663118 BACKGROUND

• Esteibar JR, Zorzano LA, Cundin EE, Blanco JD, Medina JR. Complete root coverage of Miller Class III recessions. Int J Periodontics Restorative Dent. 2011 Jul-Aug;31(4):e1-7.

  PMID: 21837295 BACKGROUND

• Kassab MM, Cohen RE. The etiology and prevalence of gingival recession. J Am Dent Assoc. 2003 Feb;134(2):220-5. doi: 10.14219/jada.archive.2003.0137.

  PMID: 12636127 BACKGROUND

• Khuller N. Coverage of gingival recession using tunnel connective tissue graft technique. J Indian Soc Periodontol. 2009 May;13(2):101-5. doi: 10.4103/0972-124X.55838.

  PMID: 20407659 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. A classification of marginal tissue recession. Int J Periodontics Restorative Dent. 1985;5(2):8-13. No abstract available.

  PMID: 3858267 BACKGROUND

• Nordland WP, Tarnow DP. A classification system for loss of papillary height. J Periodontol. 1998 Oct;69(10):1124-6. doi: 10.1902/jop.1998.69.10.1124.

  PMID: 9802711 BACKGROUND

• Raetzke PB. Covering localized areas of root exposure employing the "envelope" technique. J Periodontol. 1985 Jul;56(7):397-402. doi: 10.1902/jop.1985.56.7.397.

  PMID: 3894614 BACKGROUND

• Sculean A, Allen EP. The Laterally Closed Tunnel for the Treatment of Deep Isolated Mandibular Recessions: Surgical Technique and a Report of 24 Cases. Int J Periodontics Restorative Dent. 2018 Jul/Aug;38(4):479-487. doi: 10.11607/prd.3680.

  PMID: 29889911 BACKGROUND

• Shah R, Thomas R, Mehta DS. Recent modifications of free gingival graft: A case series. Contemp Clin Dent. 2015 Jul-Sep;6(3):425-7. doi: 10.4103/0976-237X.161910.

  PMID: 26321849 BACKGROUND

• Smith RG. Gingival recession. Reappraisal of an enigmatic condition and a new index for monitoring. J Clin Periodontol. 1997 Mar;24(3):201-5. doi: 10.1111/j.1600-051x.1997.tb00492.x.

  PMID: 9083906 BACKGROUND

• Sullivan HC, Atkins JH. Free autogenous gingival grafts. I. Principles of successful grafting. Periodontics. 1968 Jun;6(3):121-9. No abstract available.

  PMID: 5240496 BACKGROUND

• Zabalegui I, Sicilia A, Cambra J, Gil J, Sanz M. Treatment of multiple adjacent gingival recessions with the tunnel subepithelial connective tissue graft: a clinical report. Int J Periodontics Restorative Dent. 1999 Apr;19(2):199-206.

  PMID: 10635186 BACKGROUND

• Zucchelli G, Mounssif I. Periodontal plastic surgery. Periodontol 2000. 2015 Jun;68(1):333-68. doi: 10.1111/prd.12059.

  PMID: 25867992 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Manal Hosny, PhD

  Cairo University

  STUDY CHAIR

• Hani El-Nahass, PhD

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Its a randomised clinical trial

Study Record Dates

• First Submitted: December 15, 2018
• First Posted: January 2, 2019
• Study Start: August 1, 2020
• Primary Completion: March 16, 2021
• Study Completion: September 1, 2021
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

EG (1)