Novel Porous Bioceramic Material as a Bone Substitute

  • End date
    Mar 14, 2025
  • participants needed
  • sponsor
    Orton Orthopaedic Hospital
Updated on 14 August 2021


The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos-Si and Adaptos, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. New bone graft substitutes are compared with already existing treatment principles used following dental extraction.

The primary hypothesis of the study is that Adaptos-Si granules can reach a clinical outcome superior to that of dental socket left empty after extraction. Secondary aim is that new bioceramic composites can reach a clinical outcome non inferior to the active comparator of this study (Geistlisch Bio-Oss).


The purpose of this study is to evaluate new synthetic Adaptos-Si and Adaptos in ridge preservation bone grafting after dental extraction. This is partly randomized, subject and outcome assessor-blinded, controlled, single center study. The total study duration for each patient is planned to be 10 months. In total 4 visits per patient are scheduled in this study.

Subjects will undergo a single tooth extraction and then will be randomized to receive one of the four bone graft substitutes, which are Adaptos-Si (one of the the two granula sizes), Adaptos, or Geistlich Bio-Oss. Gelatin sponge is applied on the bone graft filled extraction socket. Non-randomized part of the study includes the patients that have chosen the conservative treatment option with dental socket left empty and no intention for dental implant placement. Following a healing period of 5 months, a dental implant will be placed, unless the patient has chosen the empty socket. The subject will be followed for ten months following tooth extraction. Bone ridge horizontal and vertical change assessment will be done by CBCT (primary and secondary outcome) at the time of tooth extraction, and 5 months and 10 months post-extraction.

The study device Bio-Oss (Geistlich Pharma) and Spongostan Absorbable Haemostatic Gelatin Sponge (Ferrosan Medical Devices) are CE-marked. The products are used within the indication.

Condition Alveolar Ridge Preservation
Treatment Adaptos®-Si [0.5-1 mm] (bone grafting surgery), Adaptos®-Si [1-2 mm] (bone grafting surgery), Geistlich Bio-Oss (bone grafting surgery), Tooth extraction without bone graft material, Adaptos® (bone grafting surgery)
Clinical Study IdentifierNCT04719624
SponsorOrton Orthopaedic Hospital
Last Modified on14 August 2021


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Inclusion Criteria

Patient must have voluntarily signed the informed consent
Females and males, 18 years to 80 years of age
Patient needs single tooth extraction of 1st or 2nd premolar or molar tooth
At least one adjacent teeth present
At least 3 intact walls
Subjects must be committed to the study and the required follow-up visits

Exclusion Criteria

Planned radiation or radiation during previous year in the tooth extraction area
Uncontrolled periodontitis
Alcohol or drug abuse
Pregnant or breastfeeding women
Uncontrolled diabetes
Local acute or chronic infection or presence of oral lesions or trauma
Immunosuppressive disease, treatment, or medication
Subject is part of the investigator team of this study or investigator's family member
Subject is employee of one of the organizations involve in this study
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