At a glance
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Connective Tissue Graft Versus Collagen Matrix. A 3D Digital Soft Tissue Thickening Analysis in Mucogingival Surgery: a 6 Months Follow-up Pilot Study
In Brief
A Phase 4 clinical trial evaluating Mucogingival surgery for single recession coverage for Gingival Diseases. Completed, enrolled 13 participants across 1 site.
Detailed Summary
Despite the potential role of soft tissue thickness in maintaining gingival margin stability, the existing literature has mainly focused on investigating the effect of different surgical techniques on recession coverage percentage, without taking into account the changes in tissue thickness and biotype in the surgical area. Hence, this study aims to compare threedimensional scans of gingival recessions treated either with CAF+CTG or with CAF+PDCM by the use of a dedicated superimposition software at different healing timepoints. The primary outcome is to assess the change in mm3 and the distribution pattern of soft tissue thickening in the surgical area between autologous and heterologous grafts at 1, 3, and 6 months post-surgery. The secondary outcomes are: the complete root coverage at 6 months post surgery and Patients' Reported Outcomes (PROMS) measured with oral impact on daily performances (OIDP questionnaire) and on the evaluation of patients' perception about therapy.
Study Details
Timeline
Interventions
The control group will be treated with a coronally advanced flap with vertical incisions (CAF) associated to an autologous connective tissue graft. The graft will be harvested from the palate in the area apical to the gingival margin of the second molar with an epithelial-connective harvesting technique to obtain a connective graft of 1 mm in thickness. Subsequently, the graft will be shaped in order to match height and width of the recipient site on the recession according to the technique proposed by Zucchelli in 2003. The test group will receive the same flap design with the same technique, then the porcine derived xenogeneic graft will be shaped in order to match height and width of the recipient site on the recession. In particular, the matrix will be reduced in thickness as suggested by the manufacturer to obtain a standardized thickness of 3 mm.