- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07746869
Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System (BIO-OI-TECHEIP)
Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System: A Randomized Controlled Clinical Study
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Marco Morroni
- Telefonnummer: +39 0444 289366
- E-post: m.morroni@bioteck.com
Studer Kontakt Backup
- Navn: Anna Di Bona
- E-post: a.dibona@bioteck.com
Studiesteder
-
-
Granada
-
Granada, Granada, Spania, 18071
- Unidad Clínica del Máster de Odontología Integral Avanzada e Implantología. Departamento de Estomatología. Universidad de Granada
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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%.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Implant Stability Quotient (ISQ) by Resonance Frequecy Analysis (RFA)
Tidsramme: At implant placement, at the second surgical phase (three months after implantation), and before prosthetic loading.
|
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.
|
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
Tidsramme: 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).
|
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.
|
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
Tidsramme: Prior to implant placement
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Manuel Toledano, DDS, PhD, Universidad de Granada, Granada, Spain
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2025_TIEMPOS_IMP
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .