Laterally Closed Tunnel VS Tunneling Technique in Recession Type 2

Gingival Recession Clinical Trial

Official title:

Clinical Efficacy of Laterally Closed Tunnel With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Subepithelial Connective Tissue Graft in Isolated Recession Type 2; Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791554
• Other study ID #: Perio2414
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Tunneling with subepithelial connective tissue graft:

At the recipient site (recession defect):

After scaling and root planning. A sulcular incision is made through the gingival margin and extends post the mucogingival line leaving the interdental papilla intact.

At donor site (palate):

A connective tissue graft is harvested from the palate after administration of local anesthesia using a partial thickness flap which will be raised with single incision.

Then the graft is placed and secured in the recipient site using suture. The flap is displaced to be in a coronal position using a suture.

Tunneling technique with the laterally closed tunnel):

After local anesthesia, root planing of the exposed root surface will be performed. An intrasulcular incisions will be made creating a tunnel extending to the mucogingival line and mesial and distal recession defects while keeping the interdental papilla intact as well as not perforating the flap.

• Donor SCTG Subsequently, a palatal SCTG will be harvested by means of the single incision technique with immediate closure of the donor site.

• Recipient site; Using either single or mattress sutures, the SCTG 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. Finally, the 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 1, 2021
• Est. primary completion date: March 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Group A (Lateral closed tunnel subepithelial CT graft)
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 B (Tunnel procedure with subepithelial CT graft)
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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Almanyal , Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & 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. Erratum In: J Periodontol. 2008 Jul;79(7): 1312. J Periodontol. 2008 Jul;79(7):1312. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction Recession Depth	recession depth measured from CEJ to the gingival margin in a cross-section at the central buccal site.	6 month
Secondary	Gingival recession depth.	Measured as the distance between the gingival margin and the mucogingival junction	6 month
Secondary	Gingival recession width	Measured as the distance between the gingival margin adjacent to the defect	6 month
Secondary	Root coverage esthetic score (RES)	system used to evaluated five variables 6 months gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).	6 month
Secondary	Probing depth	Measured from the gingival margin to the bottom of the gingival sulcus	6 month
Secondary	Clinical attachment level	Measured from the CEJ to the bottom of the gingival sulcus.	6 month
Secondary	Width of keratinized tissue	Measured as the distance between the gingival margin and the mucogingival junction	6 month
Secondary	Gingival thickness	The measurement of Gingival tissue thickness is performed 2 mm apical from the gingival margin.	6 month
Secondary	Post-operative pain	Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst' pain imaginable)	2 weeks
Secondary	Post-Surgical Patient Satisfaction Questionnaire	A 3-item questionnaire is asked and the patients shall use a 7-point answer scale. The answers were given on a 7-point scale ranging from 1 ''not at all'' to 7 ''very likely''	6 month
Secondary	Percentage complete root coverage	(Preoperative vertical recession -- Postoperative vertical recession/preoperative vertical recession) x 100	6 month