NCT04719624

Novel Porous Bioceramic Material as a Bone Substitute

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Orton Orthopaedic Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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®).

Detailed description

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.

Conditions

• Alveolar Ridge Preservation

Interventions

Type	Name	Description
DEVICE	Adaptos®-Si [0.5-1 mm] (bone grafting surgery)	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.
DEVICE	Adaptos®-Si [1-2 mm] (bone grafting surgery)	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.
DEVICE	Geistlich Bio-Oss (bone grafting surgery)	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.
PROCEDURE	Tooth extraction without bone graft material	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.
DEVICE	Adaptos® (bone grafting surgery)	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2021-01-22
• Last updated: 2023-11-02

Locations

1 site across 1 country: Finland