Novel Porous Bioceramic Material as a Bone Substitute

Study Overview
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Brief Summary
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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®).

Detailed Description
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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.

Official Title
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Novel Porous Bioceramic Material as a Bone Substitute. Clinical Trial.

Conditions
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Alveolar Ridge Preservation

Intervention / Treatment
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* Device: Adaptos®-Si [0.5-1 mm] (bone grafting surgery)
* Device: Adaptos®-Si [1-2 mm] (bone grafting surgery)
* Device: Geistlich Bio-Oss (bone grafting surgery)
* Procedure: Tooth extraction without bone graft material
* Device: Adaptos® (bone grafting surgery)


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adaptos-Si [0.5-1 mm]<br>Bone augmentation, after tooth extraction, with Adaptos-Si [0.5-1 mm] (synthetic bone graft material) in combination with a gelatin sponge. | Device: Adaptos®-Si [0.5-1 mm] (bone grafting surgery)<br>* 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.<br>* Other names: Ridge preservation bone grafting after tooth extraction.;|
| Experimental: Adaptos-Si [1-2 mm]<br>Bone augmentation, after tooth extraction, with Adaptos-Si [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. | Device: Adaptos®-Si [1-2 mm] (bone grafting surgery)<br>* 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.<br>* Other names: Ridge preservation bone grafting after tooth extraction.;|
| Active Comparator: Bio-Oss<br>Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft) in combination with a gelatin sponge. | Device: Geistlich Bio-Oss (bone grafting surgery)<br>* 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.<br>* Other names: Ridge preservation bone grafting after tooth extraction.;|
| Placebo Comparator: Empty extraction socket<br>Post-extraction the socket filled only by clot. | Procedure: Tooth extraction without bone graft material<br>* 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.<br>|
| Experimental: Adaptos [1-2 mm]<br>Bone augmentation, after tooth extraction, with Adaptos [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. | Device: Adaptos® (bone grafting surgery)<br>* 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.<br>* Other names: Ridge preservation bone grafting after tooth extraction.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alveolar ridge horizontal and vertical change (in mm) assessment by CBCT, comparison between Adaptos 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 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, comparisons between extraction sockets filled with Adaptos-Si or Bio-Oss bone graft substitutes. | 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 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 extraction sockets filled with Adaptos-Si or Adaptos bone graft substitutes. | 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 extraction sockets filled with Adaptos-Si or Adaptos bone graft substitutes. | baseline, 5 months, and 10 months post-extraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synthetic bone graft, Adaptos, extraction socket, dental