A Multicenter Randomized Controlled Study Comparing Connective Tissue Graft with Collagen Matrix to Re-establish Convexity At the Buccal Aspect of Single Dental Implants

Detailed Summary

Patients in need of a single implant in the premaxilla and presenting with a horizontal buccal soft tissue defect at the single tooth gap will be invited to participate in a multicenter RCT. Prior to surgery, a small-field low-dose CBCT is taken since a buccopalatal bone dimension of at least 6 mm at the central and crestal aspect of the single tooth gap is required to ensure complete embedding of an implant by bone. Sixty patients will be randomly allocated to the test group or control group in 6 centers. Each center receives 10 sealed envelopes (5 are internally labelled with 'test group' and 5 with 'control group'). For each patient a digital planning is performed in implant planning software and a tooth-supported surgical guide is fabricated. In the control group, a single implant is placed following flap elevation and surgical guide installation. Then, a CTG from the palate is positioned under the buccal mucosa to thicken the tissues. A provisional restoration is placed at the day of surgery, which is replaced by a permanent one 3m later. Patients in the test group are treated in the same way, yet a CM (Fibro-Gide®) is used instead of a CTG. Changes in the buccal soft tissue profile are registered over time by superimposing intra-oral scans in SMOP® software. Secondary outcomes included clinical, aesthetic and patient-reported outcomes.

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Interventions