- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07746869
Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System (BIO-OI-TECHEIP)
2026년 7월 30일 업데이트: Bioteck S.p.A.
Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study
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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
관찰
등록 (추정된)
40
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Marco Morroni
- 전화번호: +39 0444 289366
- 이메일: m.morroni@bioteck.com
연구 연락처 백업
- 이름: Anna Di Bona
- 이메일: a.dibona@bioteck.com
연구 장소
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Granada
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Granada, Granada, 스페인, 18071
- Unidad Clínica del Máster de Odontología Integral Avanzada e Implantología. Departamento de Estomatología. Universidad de Granada
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
기간: At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.
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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.
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At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.
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CBCT-assessed reduction in alveolar ridge height and width
기간: 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).
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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.
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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).
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Percentage of newly formed bone, residual graft material, and bone marrow/connective tissue
기간: Prior to implant placement
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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. |
Prior to implant placement
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Manuel Toledano, DDS, PhD, Universidad de Granada, Granada, Spain
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
- 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.
- Heberer S, Al-Chawaf B, Hildebrand D, Nelson JJ, Nelson K. Histomorphometric analysis of extraction sockets augmented with Bio-Oss Collagen after a 6-week healing period: a prospective study. Clin Oral Implants Res. 2008 Dec;19(12):1219-25. doi: 10.1111/j.1600-0501.2008.01617.x. No abstract available.
- Buser D, Chappuis V, Belser UC, Chen S. Implant placement post extraction in esthetic single tooth sites: when immediate, when early, when late? Periodontol 2000. 2017 Feb;73(1):84-102. doi: 10.1111/prd.12170.
- 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.
- Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057.
- 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.
- 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.
- 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.
- Gallucci GO, Benic GI, Eckert SE, Papaspyridakos P, Schimmel M, Schrott A, Weber HP. Consensus statements and clinical recommendations for implant loading protocols. Int J Oral Maxillofac Implants. 2014;29 Suppl:287-90. doi: 10.11607/jomi.2013.g4. No abstract available.
- Di Stefano DA, Artese L, Iezzi G, Piattelli A, Pagnutti S, Piccirilli M, Perrotti V. Alveolar ridge regeneration with equine spongy bone: a clinical, histological, and immunohistochemical case series. Clin Implant Dent Relat Res. 2009 Jun;11(2):90-100. doi: 10.1111/j.1708-8208.2008.00104.x. Epub 2008 Sep 9.
- Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. Post-extraction dimensional changes: A systematic review and meta-analysis. J Clin Periodontol. 2021 Jan;48(1):126-144. doi: 10.1111/jcpe.13390. Epub 2020 Nov 4.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 6월 30일
연구 완료 (추정된)
2027년 6월 30일
연구 등록 날짜
최초 제출
2026년 7월 22일
QC 기준을 충족하는 최초 제출
2026년 7월 30일
처음 게시됨 (실제)
2026년 8월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 30일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025_TIEMPOS_IMP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .