About this trial
This randomized controlled clinical study aims to compare two healing periods (4 vs 6 months) after extraction socket preservation using equine-derived enzymatically treated biomaterials (BIOTECK® system), prior to implant placement with the OITECH implant system. The study evaluates whether early implant placement at 4 months provides comparable or non-inferior outcomes to the conventional 6-month protocol in terms of primary implant stability, bone quality, and histological bone regeneration. Secondary outcomes include marginal bone level maintenance, peri-implant tissue health, implant survival, and the incidence of complications during follow-up. The goal is to generate clinical evidence to optimize the timing of implant placement without altering established treatment protocols.
Eligibility criteria
Qualifiers
Age: ≥ 18 years.
Good general health. Need for extraction of incisors, canines, or premolars due to caries, endodontic complications, root fracture, or prosthetic reasons.
Presence of three intact alveolar walls following tooth extraction, with a defect in the vestibular wall (<50%).
Need for treatment with single-tooth implants, with adjacent teeth and occlusal antagonists present.
Disqualifiers
Compromised health status. Presence of any systemic condition, such as uncontrolled diabetes mellitus, cancer, HIV, disorders that impair wound healing, chronic high-dose steroid therapy, intravenous and oral bisphosphonate therapy, metabolic bone diseases, a history of head and neck radiation, or any other immunosuppressive therapy that contraindicates oral surgical treatment.
Absence of adjacent teeth or opposing occlusal teeth.
The missing tooth is a molar.
More than one defect in the bone wall or a buccal defect >50%.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Bioteck S.p.A.
Lead sponsor
Universidad de Granada
Collaborator