Not provided
Not provided
Not provided
Not provided
Not provided
Business decision
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biomendex Oy | INDUSTRY |
| Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti | UNKNOWN |
| Tampere University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptos-Si [0.5-1 mm] | Experimental | Bone 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] | Experimental | Bone augmentation, after tooth extraction, with Adaptos-Si [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. |
|
| Bio-Oss | Active Comparator | Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft) in combination with a gelatin sponge. |
|
| Empty extraction socket | Placebo Comparator | Post-extraction the socket filled only by clot. |
|
| Adaptos [1-2 mm] | Experimental | Bone augmentation, after tooth extraction, with Adaptos [1-2 mm] (synthetic bone graft material) in combination with a gelatin sponge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptos®-Si [0.5-1 mm] (bone grafting surgery) | Device | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between radiological assessment methods | The ridge width and height are measured from 2D images of CBCT scans (in mm) and change in dimensions in time is determined using these measurements. Reduction is also measured directly on the superimposed baseline and follow-up CBCT scans (in mm).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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antero Salo, MD, DDS, PhD | Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral Hammaslääkärit Oyj, Qmedical Pikku Huopalahti | Helsinki | 00170 | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Adaptos®-Si [1-2 mm] (bone grafting surgery) | Device | 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. |
|
|
| Geistlich Bio-Oss (bone grafting surgery) | Device | 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. |
|
|
| Tooth extraction without bone graft material | Procedure | 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. |
|
| Adaptos® (bone grafting surgery) | Device | 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. |
|
|
| 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. | 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, 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 |
| baseline, 5 months, and 10 months post-extraction |
| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D014180 | Transplantation |
Not provided
Not provided