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

NCT ID: NCT06146855

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2024-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tunneling with amnion membrane

Group Type: EXPERIMENTAL

Tunneling procedure with Amnion Membrane

Intervention Type: PROCEDURE

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

Tunneling with De-epithelialized Free Gingival Graft

Group Type: ACTIVE_COMPARATOR

Tunneling procedure with De-epithelialized Free Gingival Graft

Intervention Type: PROCEDURE

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

Interventions

Tunneling procedure with Amnion Membrane

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

Intervention Type: PROCEDURE

Tunneling procedure with De-epithelialized Free Gingival Graft

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Mashaly

Assistant lecturer of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Mashaly, MSc

Role: PRINCIPAL_INVESTIGATOR

Assistant lecturer of Periodontology, Cairo University

Noha Ghallab, Phd

Role: STUDY_CHAIR

Professor of Oral Medicine and Periodontology, Cairo University

Weam El Battawy, Phd

Role: STUDY_DIRECTOR

Assistant Professor of Oral Medicine and Periodontology, Cairo University

Locations

Faculty of Oral and Dental Medicine

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Mashaly, MSc

Role: CONTACT

mohamed.mashaly@dentistry.cu.edu.eg

00201226442241

Facility Contacts

Mohamed Mashaly, Bsc

Role: primary

mohamed.mashaly@dentistry.cu.edu.eg

00201226442241

References

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.

Reference Type: BACKGROUND

PMID: 33751615 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24364174 (View on PubMed)

Other Identifiers

AMvsDFGG

Identifier Type: -

Identifier Source: org_study_id