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Novel Porous Bioceramic Material as a Bone Substitute
1 other identifier
interventional
76
1 country
1
Brief Summary
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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2023
CompletedNovember 2, 2023
October 1, 2023
1.7 years
January 13, 2021
October 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alveolar ridge preservation, comparison between Adaptos-Si filled extraction sockets and empty sockets.
Alveolar ridge horizontal and vertical change assessment by cone-beam computed tomography (CBCT). The vertical reference line is outlined from the apex through the center of the socket and the horizontal reference line through the apex perpendicular to the vertical line. The ridge width (in mm) is measured parallel to the horizontal reference line 1 mm, 3 mm, and 5 mm from the highest buccal ridge point on baseline. Ridge heights (in mm) are measured from the most apical point of the alveolar socket parallel to the vertical reference line. The dimensional changes of the ridge assessed on CBCT images immediately post-extraction, are acquired five months and ten months later. Comparison between Adaptos-Si filled extraction sockets and empty sockets.
baseline, 5 months, and 10 months post-extraction
Secondary Outcomes (3)
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparisons between extraction sockets filled with Adaptos-Si or Bio-Oss bone graft substitutes.
baseline, 5 months, and 10 months post-extraction
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparison between Adaptos filled extraction sockets and empty sockets.
baseline, 5 months, and 10 months post-extraction
Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparison between extraction sockets filled with Adaptos-Si or Adaptos bone graft substitutes.
baseline, 5 months, and 10 months post-extraction
Other Outcomes (1)
Comparison between radiological assessment methods
baseline, 5 months, and 10 months post-extraction
Study Arms (5)
Adaptos-Si [0.5-1 mm]
EXPERIMENTALBone augmentation, after tooth extraction, with Adaptos-Si \[0.5-1 mm\] (synthetic bone graft material) in combination with a gelatin sponge.
Adaptos-Si [1-2 mm]
EXPERIMENTALBone augmentation, after tooth extraction, with Adaptos-Si \[1-2 mm\] (synthetic bone graft material) in combination with a gelatin sponge.
Bio-Oss
ACTIVE COMPARATORBone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft) in combination with a gelatin sponge.
Empty extraction socket
PLACEBO COMPARATORPost-extraction the socket filled only by clot.
Adaptos [1-2 mm]
EXPERIMENTALBone augmentation, after tooth extraction, with Adaptos \[1-2 mm\] (synthetic bone graft material) in combination with a gelatin sponge.
Interventions
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth and the socket is filled only by clot. Subject will be followed at 2 weeks, 5 months, and 10 months for healing.
After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Planned radiation or radiation during previous year in the tooth extraction area.
- Smoking
- Osteoporosis
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Orton Orthopaedic Hospitallead
- Biomendex Oycollaborator
- Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahticollaborator
- Tampere Universitycollaborator
Study Sites (1)
Oral Hammaslääkärit Oyj, Qmedical Pikku Huopalahti
Helsinki, 00170, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antero Salo, MD, DDS, PhD
Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2021
First Posted
January 22, 2021
Study Start
June 1, 2021
Primary Completion
January 27, 2023
Study Completion
January 27, 2023
Last Updated
November 2, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share