Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System

Официальное название

Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study

Обзор

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.

Первичные конечные точки

• Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA) [Срок оценки: At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.]
• CBCT-assessed reduction in alveolar ridge height and width [Срок оценки: One scan immediately after regenerative surgery (T0) and a second scan after a healing period of 6 or 4 months, prior to implant placement (T1).]
• Percentage of newly formed bone, residual graft material, and bone marrow/connective tissue [Срок оценки: Prior to implant placement]

Критерии участия

Критерии включения

• 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.
• Sufficient available bone, as assessed by CBCT, for the placement of implants 3.6 mm in diameter and 10 mm in length.
• Periodontal health with intact or reduced periodontium. Full-mouth plaque and bleeding scores < 20%.
• Ability and willingness to follow the study procedures and instructions.

Критерии исключения

• 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%.
• Allergy or hypersensitivity to medications or any product used during the study.
• Regular use of tobacco (defined as >1 cigarette per day) or chewing tobacco, even within the 3 months prior to enrollment.
• Untreated periodontitis.
• Acute periapical or periodontal infection.
• Oral plaque and/or bleeding > 20%.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Испания · 1 центр

• Unidad Clínica del Máster de Odontología Integral Avanzada e Implantología. Departamento d — Granada

Публикации

• Urban IA, Monje A. Guided Bone Regeneration in Alveolar Bone Reconstruction. Oral Maxillofac Surg Clin North Am. 2019 May;31(2):331-338. doi: 10.1016/j.coms.2019.01.003. PMID 30947850
• Toledano M, Vallecillo C, Gutierrez-Corrales A, Torres-Lagares D, Toledano-Osorio M, Serrera-Figallo MA. Histomorphometric Analysis of Differential Regional Bone Regeneration Induced by Distinct Doped Membranes. Polymers (Basel). 2022 May 19;14(10):2078. doi: 10.3390/polym14102078. PMID 35631960
• Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x. PMID 22211303
• Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23. PMID 12956475
• Sanz M, Cecchinato D, Ferrus J, Pjetursson EB, Lang NP, Lindhe J. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla. Clin Oral Implants Res. 2010 Jan;21(1):13-21. doi: 10.1111/j.1600-0501.2009.01824.x. Epub 2009 Nov 18. PMID 19922492
• Monje A, Ravida A, Wang HL, Helms JA, Brunski JB. Relationship Between Primary/Mechanical and Secondary/Biological Implant Stability. Int J Oral Maxillofac Implants. 2019 Suppl;34:s7-s23. doi: 10.11607/jomi.19suppl.g1. PMID 31116830
• Mardas N, Trullenque-Eriksson A, MacBeth N, Petrie A, Donos N. Does ridge preservation following tooth extraction improve implant treatment outcomes: a systematic review: Group 4: Therapeutic concepts & methods. Clin Oral Implants Res. 2015 Sep;26 Suppl 11:180-201. doi: 10.1111/clr.12639. Epub 2015 Jun 16. PMID 26078004
• Lages FS, Douglas-de Oliveira DW, Costa FO. Relationship between implant stability measurements obtained by insertion torque and resonance frequency analysis: A systematic review. Clin Implant Dent Relat Res. 2018 Feb;20(1):26-33. doi: 10.1111/cid.12565. Epub 2017 Dec 1. PMID 29194944

Идентификаторы

NCT: NCT07746869 · 2025_TIEMPOS_IMP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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