Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study
| Registry | NCT07746869, acronym BIO-OI-TECHEIP |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 40 (Estimated) |
| Sponsor | Bioteck S.p.A. (Industry); collaborators: Universidad de Granada |
| Conditions | Alveolar Bone Resorption |
| Dates | start 2026-09-01 (estimated), primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2026-08-05, last updated 2026-08-05 |
| Locations | 1 site in Spain |
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All trials for Alveolar Bone Resorption
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test group | Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 4 months after GBR procedure. | ||
| Control group | Guided bone regeneration procedure with Activabone® Mouldable Paste, as bone graft, the pericardium collagen membrane (Heart®) and stabilized with the collagen matrix Xenomatrix® (Bioteck S.p.A., Italy). Implant OITECH will be inserted 6 months after GBR procedure. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Age: ≥ 18 years. 2. Good general health. Need for extraction of incisors, canines, or premolars due to caries, endodontic complications, root fracture, or prosthetic reasons. 3. Presence of three intact alveolar walls following tooth extraction, with a defect in the vestibular wall (<50%). 4. Need for treatment with single-tooth implants, with adjacent teeth and occlusal antagonists present. 5. Sufficient available bone, as assessed by CBCT, for the placement of implants 3.6 mm in diameter and 10 mm in length. 6. Periodontal health with intact or reduced periodontium. Full-mouth plaque and bleeding scores < 20%. 7. Ability and willingness to follow the study procedures and instructions. Exclusion Criteria: 1. 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. 2. Absence of adjacent teeth or opposing occlusal teeth. 3. The missing tooth is a molar. 4. More than one defect in the bone wall or a buccal defect >50%. 5. Allergy or hypersensitivity to medications or any product used during the study. 6. Regular use of tobacco (defined as >1 cigarette per day) or chewing tobacco, even within the 3 months prior to enrollment. 7. Untreated periodontitis. 8. Acute periapical or periodontal infection. 9. Oral plaque and/or bleeding > 20%.
| Facility | City | Country | Status |
|---|---|---|---|
| Unidad Clínica del Máster de Odontología Integral Avanzada e Implantología. Departamento de Estomatología. Universidad de Granada | Granada, Granada | Spain |