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

NCT06146855 | Recruiting DMC

• 1 other identifier: AMvsDFGG
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Recession depth

  Measured from the CEJ to the most apical extension of the gingival margin.

  3-6 month

Secondary Outcomes (8)

• Recession width

  3-6 month

• Percentage of root coverage

  6 months

• Root coverage esthetic score

  6 months

• Gingival Thickness

  3-6 months

• Keratinized tissue width

  3-6 months

Study Arms (2)

Tunneling with amnion membrane

EXPERIMENTAL

Procedure: Tunneling procedure with Amnion Membrane

Tunneling with De-epithelialized Free Gingival Graft

ACTIVE COMPARATOR

Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft

Interventions

Tunneling procedure with Amnion Membrane PROCEDURE

Root Coverage by tunneling procedure with the addition of Amnion Membrane as a soft tissue substitute

Tunneling with amnion membrane

Tunneling procedure with De-epithelialized Free Gingival Graft PROCEDURE

Root Coverage by tunneling procedure with the addition of De-epithelialized Free Gingival Graft

Tunneling with De-epithelialized Free Gingival Graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, 12114, Egypt

RECRUITING

Related Publications (2)

• 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.

  PMID: 33751615 BACKGROUND

• 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.

  PMID: 24364174 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed Mashaly, MSc

  Assistant lecturer of Periodontology, Cairo University

  PRINCIPAL INVESTIGATOR

• Noha Ghallab, Phd

  Professor of Oral Medicine and Periodontology, Cairo University

  STUDY CHAIR

• Weam El Battawy, Phd

  Assistant Professor of Oral Medicine and Periodontology, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed Mashaly, MSc

CONTACT

00201226442241; mohamed.mashaly@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Periodontology

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: November 27, 2023
• Study Start: February 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

EG (1)