Clinician- and patient-reported outcome measures (ClinROs/PROMs) fol-lowing implant placement with open vs submerged healing of native collagen membranes (BioGide® Compressed)

Authors
Category Primary study
Registry of TrialsGerman Clinical Trials Register
Year 2026
INTERVENTION: Group 1: Test group: The implant and the bone graft material heal by open healing (no closure after fixation of the membrane) Group 2: Control group: The implant and the bone graft material heal by submerged healing. A second surgical procedure is required three months after the initial surgery in order to establish the connection between the implant and the crown. CONDITION: This pilot study aims to investigate the ease of performing open healing (exposed implant abutment) after implant placement compared to the standard procedure where the implant is submerged. PRIMARY OUTCOME: Primary endpoint:; Ease of treatment by NRS based questionnaire directly after implant placement SECONDARY OUTCOME: Secondary endpoints: ; • Duration of surgery ; • Wound healing inde X(wound closure) at suture removal ; • Swelling at suture removal ; • PROMs: pain during the first 24h after surgery, patient’s satisfaction, OHIP‐14 ; • Clinical measurements (BOP, PI, PD, width of keratinised tissue) at Baseline, 6 months, 1‐ and 3‐years ; • Implant survival at Baseline, 6 months, 1‐ and 3‐years ; • Marginal bone level changes between Baseline and the 1y and 3y follow‐ups INCLUSION CRITERIA: • Informed Consent signed by the subject • Need for a 1‐piece implant in the posterior region (premolar or molar) in the mandible/maxilla • At least 1 neighbouring tooth or implant • Presence of at least 2mm width of keratinised mucosa pre‐implantation • Periodontally healthy patients (periodontal probing depths ? 4mm) (full mouth) • Good oral hygiene (Plaque Control Record <25%; (O'Leary et al., 1972)) • Adequate control of inflammation (full mouth bleeding on probing <25%; (Ainamo & Bay, 1975)) • Capability to comply with the study procedures
Epistemonikos ID: 77cc5dfebaeada161ba40cdda92810588c1d4053
First added on: Aug 08, 2026