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.
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.
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%.
Potential participants will be identified among patients treated at the University of Granada's Clinic for Advanced Comprehensive Dentistry and Implantology and Periodontology and Implants, either during routine diagnostic visits or through internal referrals. Patients who have a tooth-preferably an anterior tooth or premolar-for which extraction is clinically indicated and who express their intention to restore the area through the subsequent placement of a dental implant will be considered potential candidates.
Case-control
Prospective
Not listed
Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
Implant stability will be assessed using resonance frequency analysis (RFA) with the Osstell IDx device (Osstell, Gothenburg, Sweden), which provides Implant Stability Quotient (ISQ) values. Two measurements will be obtained for each implant, one in the mesiodistal direction and one in the buccolingual/palatal direction. ISQ values range from 1 to 99, with higher values indicating greater implant stability. The same operator will perform all stability measurements.
CBCT-assessed reduction in alveolar ridge height and width
Each patient will undergo Cone Beam Computed Tomography (CBCT) scans to assess changes in height and width. The cross-sections from T0 and T1 will be superimposed and aligned to determine the following reference lines. The percentage reduction in height and width will be calculated.
Percentage of newly formed bone, residual graft material, and bone marrow/connective tissue
The cylindrical bone sample extracted during implant site preparation will be analyzed. The sample will undergo resin embedding without decalcification and histological preparation for subsequent staining (toluidine blue, Von Kossa, and hematoxylin/eosin). Histomorphometric analysis will be performed using optical microscopy and image analysis software to quantify the percentage of each tissue component within the biopsy specimen.
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Bioteck S.p.A.
Lead sponsor
Universidad de Granada
Collaborator
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