An interventional study of Tunneling procedure with Amnion Membrane and Tunneling procedure with De-epithelialized Free Gingival Graft in Gingival Recession, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's planned enrollment of 22 is below the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Tunneling procedure with Amnion Membrane
Procedure: Tunneling procedure with De-epithelialized Free Gingival Graft
Root Coverage by tunneling procedure with the addition of Amnion Membrane as a soft tissue substitute
Root Coverage by tunneling procedure with the addition of De-epithelialized Free Gingival Graft
Recession depth
Measured from the CEJ to the most apical extension of the gingival margin.
Time frame: 3-6 month
Recession width
Measured horizontally between the borders of the recession.
Time frame: 3-6 month
Percentage of root coverage
(Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100.
Time frame: 6 months
Root coverage esthetic score
Based 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).
Time frame: 6 months
Gingival Thickness
Determined 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).
Time frame: 3-6 months
Keratinized tissue width
Measured as the distance between the gingival margin and the mucogingival junction (MGJ).
Time frame: 3-6 months
Post-Operative Pain
Visual Analogue Scale (VAS) with numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first week postoperatively.
Time frame: 1 week
Post-Surgical Patient Satisfaction
A 3-item questionnaire is asked and the patients shall use a 7- point answer scale. (Kiyak et al., 1984)
Time frame: 1 week
Surgical time
Total time of the surgical procedure measured using a stopwatch.
Time frame: intraoperative
Plan to share: Yes
Supporting information: Study protocol, Icf, Csr
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Cairo University