search
Back to results

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

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
DGG + TUN
SCTG + TUN
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring gingival recessions, connective tissue graft, de-epithelialized gingival graft, tunnel technique

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • 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.

Exclusion Criteria:

  • • 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.

Sites / Locations

  • Sila Isler

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

DGG + TUN

SCTG + TUN

Arm Description

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

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

Outcomes

Primary Outcome Measures

Root coverage outcomes
Mean root coverage of DGG versus SCTG with TUN

Secondary Outcome Measures

Root coverage outcomes
Complete root coverage of DGG versus SCTG with TUN
Root coverage outcomes
Recession depth
patient morbidity
postoperative pain
patient morbidity
patients' discomfort
histopathological features of the graft
graft cellularity
histopathological features of the graft
vascularization

Full Information

First Posted
February 24, 2020
Last Updated
February 27, 2020
Sponsor
Gazi University
search

1. Study Identification

Unique Protocol Identification Number
NCT04291963
Brief Title
The Efficacy of De-epithelialized Free Gingival Graft on Treatment of Multiple Gingival Recessions With Tunnel Technique
Official Title
De-epithelialized Gingival Graft Versus Subepithelial Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions Using the Tunnel Technique
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 9, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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, variations in the depth and width of the adjacent recession defects, shallow vestibules and high frenum attachments. Furthermore, in these cases, wound healing is often more difficult due to factors such as larger avascular surface and poor blood supply. The coronally advanced flap (CAF) or the tunnel technique (TUN) with graft-based subepithelial connective tissue procedures have been reported to be the most predictable methods for the treatment of MAGRs. On account of the advantages of TUN, including superior blood supply and advanced wound healing owing to its conservative characteristics associated with the flap elevation without papillae dissection or vertical releasing incisions, this approach has recently achieved popularity compared to other methods. Although the use of connective tissue grafts (CTGs), together with various surgical techniques, has been accepted as "the gold standart" for the treatment of GRs, some disadvantages of CTG are underlined. Limited donor tissue in the cases where inadequate amount of palatal tissue thickness and/or a bigger dimension of CTG is needed, as in the treatment of MAGRs are claimed to be among those disadvantages (Zucchelli et al., 2010). Moreover, subepitelial CTG (SCTG), either harvested by 'trap-door' (TD) or 'single-incision' (SI) approaches, have been frequently associated with post-operative pain and discomfort, as well as palatal flap necrosis/dehiscence at the donor site. To overcome these limitations, and obtain a firmer and uniform CTG, de-epithelializing of the free gingival grafts (FGG) have been proposed, especially when palatal fibromucosal tissue thickness is inadequate (≤2.5 mm) and a large graft dimension in apico-coronal or mesio-distal directions is required. De-epithelialized gingival graft (DGG) have also been suggested to have less prone to post-operative shrinkage, because of obtaining larger amount of collagen-rich connective tissue from lamina propria, minimal amount of fatty/glandular tissue and less number of medium to large vessels. Previously it was reported that DGG applied with the TUN presented better manuplation in recipent area and reduced postoperative morbidity compared to a conventional CTG, and resulted in a successful root coverage outcome with increased both width and thickness of the keratinized tissue in the treatment of MAGRs. In a randomized clinical trial (RCT), Zuchelli et al. found no significant differences regarding post-operative pain and root coverage outcomes when compared SCTG and DGG in combination with CAF in the treatment of single or multiple GRs. However, a significant difference was observed in terms of keratinized tissue thickness (KTT) in favor of DGG, and this finding was attributed to the its characteristics of better stability, low shrinkage rates and to allow the incorporation of the portion of connective tissue closest to the epithelium. Despite all biologically advantages of DGG, there is scarce information in the literature on its clinical significance in combination with TUN compared to conventional CTG procedures in the treatment of MAGRs. Therefore, the present study aimed to investigate the clinical efficacy and postoperative morbidity of DGG compared to SCTG on treatment of MAGRs with TUN. The primary objective was to assess the root coverage outcomes of DGG versus SCTG with TUN at 1-year postoperatively. The secondary objectives were to evaluate postoperative patient morbidity of these procedures and the characteristics of the grafts harvested by these two different techniques histopathologically and histomorphometrically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
gingival recessions, connective tissue graft, de-epithelialized gingival graft, tunnel technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DGG + TUN
Arm Type
Active Comparator
Arm Description
The multiple adjacent gingival recession sites were treated with DGG in conjunction with TUN technique.
Arm Title
SCTG + TUN
Arm Type
Active Comparator
Arm Description
The multiple adjacent gingival recession sites were treated with SCTG in conjunction with TUN technique.
Intervention Type
Procedure
Intervention Name(s)
DGG + TUN
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
SCTG + TUN
Intervention Description
In SCTG group, graft was harvested through the single-incision approach at palatal mucosa
Primary Outcome Measure Information:
Title
Root coverage outcomes
Description
Mean root coverage of DGG versus SCTG with TUN
Time Frame
1-year postoperatively
Secondary Outcome Measure Information:
Title
Root coverage outcomes
Description
Complete root coverage of DGG versus SCTG with TUN
Time Frame
1-year postoperatively
Title
Root coverage outcomes
Description
Recession depth
Time Frame
1-year postoperatively
Title
patient morbidity
Description
postoperative pain
Time Frame
up to 28 days postoperatively
Title
patient morbidity
Description
patients' discomfort
Time Frame
up to 28 days postoperatively
Title
histopathological features of the graft
Description
graft cellularity
Time Frame
through study completion, an average of 1 year
Title
histopathological features of the graft
Description
vascularization
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • 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. Exclusion Criteria: • 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu C Ozdemir, Assoc Prof
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Sila Isler
City
Ankara
ZIP/Postal Code
06510
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29757468
Citation
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.
Results Reference
result
PubMed Identifier
27446995
Citation
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.
Results Reference
result
PubMed Identifier
25315018
Citation
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.
Results Reference
result
PubMed Identifier
29761502
Citation
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.
Results Reference
result
PubMed Identifier
23627374
Citation
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.
Results Reference
result
PubMed Identifier
25644302
Citation
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.
Results Reference
result
PubMed Identifier
23346965
Citation
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.
Results Reference
result
PubMed Identifier
20590963
Citation
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.
Results Reference
result
PubMed Identifier
9497718
Citation
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.
Results Reference
result
PubMed Identifier
7928129
Citation
Bruno JF. Connective tissue graft technique assuring wide root coverage. Int J Periodontics Restorative Dent. 1994 Apr;14(2):126-37.
Results Reference
result
PubMed Identifier
10635174
Citation
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.
Results Reference
result
PubMed Identifier
11203571
Citation
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.
Results Reference
result
PubMed Identifier
17209793
Citation
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.
Results Reference
result
PubMed Identifier
26814715
Citation
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.
Results Reference
result
PubMed Identifier
30007054
Citation
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.
Results Reference
result
PubMed Identifier
12816304
Citation
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.
Results Reference
result
PubMed Identifier
17514885
Citation
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.
Results Reference
result
PubMed Identifier
22140664
Citation
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.
Results Reference
result
PubMed Identifier
24640997
Citation
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.
Results Reference
result
PubMed Identifier
30794258
Citation
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.
Results Reference
result
PubMed Identifier
26291293
Citation
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.
Results Reference
result
PubMed Identifier
31376154
Citation
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.
Results Reference
result
PubMed Identifier
19792859
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs