| NCT ID | NCT05663385 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Dental Implant |
| Study Type | OBSERVATIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-04-16 |
| Primary Completion | 2025-08-14 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Rationale: Early implant placement with alveolar ridge preservation (ARP) using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP, up to 1 year after functional loading. Objective: The aim of this study is to evaluate esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing 5 years after loading Study design: prospective observational study with 5-year follow-up Intervention (if applicable): not applicable Main study parameters/endpoints: Comparison of the level of the buccal marginal gingiva (midfacial mucosa level) between ARP versus spontaneous healing Secondary parameters/endpoint: Peri-implant esthetic score (PES) and white esthetic score (WES), complications, implant survival; and success, Plaque Index, Modified bleeding index, Gingival Index, Probing Depth, PROMs, bone and soft tissue volumetric dimensional changes.
Eligibility Criteria
Inclusion Criteria: * All patients previously included in the above mentioned RCT. Exclusion Criteria: * Patients treated with radiotherapy during follow-up in the head-and-neck region or current chemotherapy; disability (mental and/or physical) to maintain basic oral hygiene procedures.