Clinical trial NCT06146855: Amnion Membrane Versus DFGG Using the Tunneling Technique in Management of Gingival Recession Defects.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Recession depth
timeFrame: 3-6 month
Secondary outcomes:
measure: Recession width
timeFrame: 3-6 month
measure: Percentage of root coverage
timeFrame: 6 months
measure: Root coverage esthetic score
timeFrame: 6 months
measure: Gingival Thickness
timeFrame: 3-6 months
measure: Keratinized tissue width
timeFrame: 3-6 months
measure: Post-Operative Pain
timeFrame: 1 week
measure: Post-Surgical Patient Satisfaction
timeFrame: 1 week
measure: Surgical time
timeFrame: intraoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine
Study officials:
affiliation: Assistant lecturer of Periodontology, Cairo University
name: Mohamed Mashaly, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Oral Medicine and Periodontology, Cairo University
name: Noha Ghallab, Phd
role: STUDY_CHAIR
affiliation: Assistant Professor of Oral Medicine and Periodontology, Cairo University
name: Weam El Battawy, Phd
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.