Amnion Membrane Versus DFGG Using the Tunneling Technique in Management of Gingival Recession Defects.

Amnion Membrane as a Soft Tissue Substitute Versus De- Epithelialized Free Gingival Graft Using the Tunneling Technique in Management of Gingival Recession Defects: A Randomized Controlled Clinical Trial.

Treatment of gingival recession is indicated mainly for esthetic reasons and keratinized tissue augmentation (Zucchelli and Mounssif, 2015). An array of surgical techniques has been proposed by the literature to cover gingival recession defects with well-documented successful outcomes. The selection of one technique over the other depends on many factors. Some of these factors are related to the gingival recession defect itself, others are related to the anatomy of the palatal fibromucosa, or related to the patient variabilities (Zucchelli and De Sanctis, 2000).

Controversy exists in the literature regarding the patient morbidity after connective tissue graft harvesting. Inconclusive postulations have been made about the post-operative patient morbidity outcomes and root coverage outcomes when comparing connective tissue graft harvesting in comparison to allograft membranes used for root coverage.

The use of connective tissue graft in combination with root coverage techniques remain the gold standard for root coverage procedures. The problem with the connective tissue graft is that harvesting a graft from the palate increases morbidity, needs an extra surgical site which is more traumatic for the patient, depends on the donor tissue which could be limited, increases surgical chair-time and needs increased surgical skills (Cortellini & Pini Prato 2012).

The rationale behind the use of amnion membrane is to avoid the morbidity inherent with connective tissue graft harvesting.

Study Overview

• Status: Recruiting
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Tunneling procedure with Amnion Membrane; Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed Mashaly, MSc; Phone Number: 00201226442241; Email: mohamed.mashaly@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12114
    • Recruiting
    • Faculty of Oral and Dental Medicine
    • Contact: Mohamed Mashaly, Bsc; Phone Number: 00201226442241; Email: mohamed.mashaly@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18 and 60 years.
• Periodontally and systemically healthy.
• Presence of RT1 or RT2 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.

Exclusion Criteria:

• RT3 recession defects.
• Smokers as smoking is a contraindication for any plastic periodontal surgery (Khuller, 2009).
• 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.
• Uncooperative patients not willing to complete the follow up period.
• Pregnancy and lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tunneling with amnion membrane	Procedure: Tunneling procedure with Amnion Membrane; Root Coverage by tunneling procedure with the addition of Amnion Membrane as a soft tissue substitute
Active Comparator: Tunneling with De-epithelialized Free Gingival Graft	Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft; Root Coverage by tunneling procedure with the addition of De-epithelialized Free Gingival Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recession depth	Measured from the CEJ to the most apical extension of the gingival margin.	3-6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of root coverage	(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.	6 months
Recession width	Measured horizontally between the borders of the recession.	3-6 month
Root coverage esthetic score	Based on Cairo et al., (2009) the root coverage esthetic score (RES) system evaluated five variables 6 months following surgery: gingival margin (GM), marginal tissue contour (MTC), soft tissue texture (STT), MGJ alignment, and gingival color (GC).	6 months
Gingival Thickness	Determined 2 mm apical to the gingival margin with a short needle for anesthesia and a 3 mm diameter silicon disk stop. The needle is inserted perpendicular to the mucosal surface, through the soft tissues with light pressure until a hard surface is felt. The silicon disk stop is then placed in tight contact with the soft tissue surface with the coronal border overlapping the soft tissue margin. As the needle is located in the center of the silicon disk, measurement of GT is performed 2 mm apical from the gingival margin. After careful removal of the needle, the penetration depth is measured with a caliper accurate to the nearest 0.1 mm (Paolantonio et al., 2002; da Silva et al., 2004; Joly et al., 2007).	3-6 months
Keratinized tissue width	Measured as the distance between the gingival margin and the mucogingival junction (MGJ).	3-6 months
Post-Operative Pain	Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first week postoperatively.	1 week
Post-Surgical Patient Satisfaction	A 3-item questionnaire is asked and the patients shall use a 7- point answer scale. (Kiyak et al., 1984)	1 week
Surgical time	Total time of the surgical procedure measured using a stopwatch.	intraoperative

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Mohamed Mashaly, MSc, Assistant lecturer of Periodontology, Cairo University; Study Chair: Noha Ghallab, Phd, Professor of Oral Medicine and Periodontology, Cairo University; Study Director: Weam El Battawy, Phd, Assistant Professor of Oral Medicine and Periodontology, Cairo University

Publications and helpful links

General Publications

• Bakhishov H, Isler SC, Bozyel B, Yildirim B, Tekindal MA, Ozdemir B. De-epithelialized gingival graft versus subepithelial connective tissue graft in the treatment of multiple adjacent gingival recessions using the tunnel technique: 1-year results of a randomized clinical trial. J Clin Periodontol. 2021 Jul;48(7):970-983. doi: 10.1111/jcpe.13452. Epub 2021 Apr 7.
• Ghahroudi AA, Khorsand A, Rokn AR, Sabounchi SS, Shayesteh YS, Soolari A. Comparison of amnion allograft with connective tissue graft for root coverage procedures: a double-blind, randomized, controlled clinical trial. J Int Acad Periodontol. 2013 Oct;15(4):101-12.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 18, 2023
• First Submitted That Met QC Criteria: November 24, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: AMvsDFGG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No