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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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06146855
Enrollment
22
Registered
2023-11-27
Start date
2024-02-05
Completion date
2024-12-01
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

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.

Interventions

PROCEDURETunneling procedure with Amnion Membrane

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

PROCEDURETunneling procedure with De-epithelialized Free Gingival Graft

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Recession depth3-6 monthMeasured from the CEJ to the most apical extension of the gingival margin.

Secondary

MeasureTime frameDescription
Percentage of root coverage6 months(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Root coverage esthetic score6 monthsBased 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).
Gingival Thickness3-6 monthsDetermined 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).
Recession width3-6 monthMeasured horizontally between the borders of the recession.
Post-Operative Pain1 weekVisual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first week postoperatively.
Post-Surgical Patient Satisfaction1 weekA 3-item questionnaire is asked and the patients shall use a 7- point answer scale. (Kiyak et al., 1984)
Surgical timeintraoperativeTotal time of the surgical procedure measured using a stopwatch.
Keratinized tissue width3-6 monthsMeasured as the distance between the gingival margin and the mucogingival junction (MGJ).

Countries

Egypt

Contacts

Primary ContactMohamed Mashaly, MSc
mohamed.mashaly@dentistry.cu.edu.eg00201226442241

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026