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Comparing Deepithelialized Free Gingival Graft Versus Subpithelial Connective Tissue Graft With Tunneling Technique in Treating RT2 Gingival Recession

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ClinicalTrials.gov Identifier: NCT04104087
Recruitment Status : Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Elshourbagy, Cairo University

Brief Summary:

Complete coverage of the recession complemented with pleasing esthetics and minimal probing measures are the main goals of root coverage procedures.

According to a consensus report from the AAP regeneration workshop on the periodontal soft tissue root coverage procedures; most studies have been directed on RT-1 (Miller Class I and II) defects and that further research on results in RT-2, RT-3 ( Miller Class III and IV) defects is needed. Consequently, it was planned to conduct this research on RT-2 (Miller Class III) recessions to overcome this gap of knowledge, de-epithelialized free gingival graft is proposed aiming to enhance the papillary height, esthetic, with less pain and postoperative trauma. Equally, it is considered a more conservative approach with fewer complications.


Condition or disease Intervention/treatment Phase
RT2 Gingival Recession Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft. Phase 4

Detailed Description:

Gingival recession has high prevalence among both individuals with periodontal disease and those with high standers of oral hygiene. The management of RT-2 ( Miller Class III) gingival recessions is very challenging and there is controversy in the literature concerning the most predictable approach to treat these defects.

Treatment of gingival recession is performed to enhance esthetics, reduce dentinal hypersensitivity, eliminate caries risk, stop the progression of gingival recession and periodontal attachment loss and keratinized tissue augmentation to enable the patient to maintain adequate plaque control.Gingival recession or "Marginal tissue recession" is recognized as the apical migration of the marginal gingiva to its normal position on the root surface. Connective tissue graft (CTG) is considered to be the best root coverage techniques for the treatment of gingival recession defects.

However, it is challenging sometimes to harvest the largest volume of tissue especially in thin palatal tissue as recently it was recommended to keep 2mm of soft tissue thickness covering the palate to minimize the postoperative pain. Otherwise, necrosis/dehiscence of the flap may happen which was reported to occur frequently for the trap-door approach. Moreover, it is necessary to extend the dissection deeper into the palatal tissues to leave adequate thickness of connective tissue to maintain the vitality of the primary flap which may cause more painful post-operative course.

To overcome these limitations, CTG harvesting with de-epithelialized gingival grafts (DGG) can be executed even in the presence of thin palatal tissues. CTG preparation can be performed more superficially by this approach to obtain collagen-rich connective tissue from Lamina pro- pria of the palatal mucosa. The findings of Zucchelli et al. study support the observation that CTGs which are presumed to have denser connective tissue are comparatively less prone to post-operative shrinkage . According to this assumption, DGG technique may enable to harvest an adequate amount of dense and stable tissue

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: it is randomized control trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: double
Primary Purpose: Treatment
Official Title: The Effect of the Tunneling Technique With Subepithelial Connective Tissue Graft Versus Tunneling Technique With Deepithelialized Free Gingival Graft on the Papillary Height in the Treatment of RT2 Recession Defect: a Randomized Clinical Trial.
Estimated Study Start Date : October 10, 2019
Estimated Primary Completion Date : July 10, 2020
Estimated Study Completion Date : April 10, 2021

Arm Intervention/treatment
Experimental: deepithelializ free gingival graft
performing tunneling technique with deepithelialized free gingival graft in treating RT2 gingival recession
Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
enhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
Other Name: root coverage

Active Comparator: subepithelial connective tissue graft
performing tunneling technique with sub epithelial connective tissue graft in treating RT2 gingival recession
Procedure: tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
enhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
Other Name: root coverage




Primary Outcome Measures :
  1. the distance between the contact point and the top of the papilla [ Time Frame: 9 months ]
    measuring the distance between the contact point and the top of the papilla by graduated William's periodontal probe



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   the minimum age should be 18 years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients 18 years or older. Patients with healthy systemic condition. Buccal recession defects classified as RT-2 recession defects. Clinical indication and/or patient request for recession coverage. O'Leary index less than 20% . No cervical caries or non-carious lesion. No history of periodontal plastic surgery in the affected site

Exclusion Criteria:

Pregnant females. Smokers as smoking 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.

Overlapping teeth or teeth with abnormal alignment in the dental arch.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104087


Contacts
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Contact: sarah Elshourbagy, MSC 01288624000 sara_elshourbagy@hotmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Manal Hosny, phd Cairo University
Study Chair: Hani ElNahass, PHD Cairo University
Publications of Results:
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Responsible Party: Sarah Elshourbagy, teaching assistant, Cairo University
ClinicalTrials.gov Identifier: NCT04104087    
Other Study ID Numbers: perio 331
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: I will check with my study chair

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sarah Elshourbagy, Cairo University:
tunneling technique, gingival recession, deepithelialized free gingival graft, sub epithelial connective tissue graft,
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy