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Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using BIOTECK Materials and OITECH Implant System (BIO-OI-TECHEIP)

30. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Studietype

Observasjonsmessig

Registrering (Antatt)

40

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Granada
      • Granada, Granada, Spania, 18071
        • Unidad Clínica del Máster de Odontología Integral Avanzada e Implantología. Departamento de Estomatología. Universidad de Granada

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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%.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Manuel Toledano, DDS, PhD, Universidad de Granada, Granada, Spain

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

22. juli 2026

Først innsendt som oppfylte QC-kriteriene

30. juli 2026

Først lagt ut (Faktiske)

5. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2025_TIEMPOS_IMP

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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