Novel Porous Bioceramic Material as a Bone Substitute

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®).

Conditions

• Alveolar Ridge Preservation

Interventions

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.

Sponsors & Collaborators

• Biomendex Oy

  collaborator INDUSTRY

• Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti

  collaborator UNKNOWN

• Tampere University

  collaborator OTHER

• Orton Orthopaedic Hospital

  lead OTHER

Principal Investigators

• Antero Salo, MD, DDS, PhD · Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2023-01-27

Completion

2023-01-27

Countries

• Finland

Study Locations