ClinicalTrials.Veeva

Menu

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

Cairo University (CU) logo

Cairo University (CU)

Status

Enrolling

Conditions

Gingival Recession

Treatments

Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft
Procedure: Tunneling procedure with Amnion Membrane

Study type

Interventional

Funder types

Other

Identifiers

NCT06146855
AMvsDFGG

Details and patient eligibility

About

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.

Enrollment

22 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

Tunneling with amnion membrane
Experimental group
Treatment:
Procedure: Tunneling procedure with Amnion Membrane
Tunneling with De-epithelialized Free Gingival Graft
Active Comparator group
Treatment:
Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft

Trial contacts and locations

1

Loading...

Central trial contact

Mohamed Mashaly, MSc

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems