Novel Porous Bioceramic Material as a Bone Substitute

NATerminatedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

January 27, 2023

Study Completion Date

January 27, 2023

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.

Trial Locations (1)

00170

Oral Hammaslääkärit Oyj, Qmedical Pikku Huopalahti, Helsinki

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biomendex Oy

INDUSTRY

collaborator

Oral Hammaslääkärit Oy, Qmedical Pikku Huopalahti

UNKNOWN

collaborator

Tampere University

OTHER

lead

Orton Orthopaedic Hospital

OTHER

NCT04719624 - Novel Porous Bioceramic Material as a Bone Substitute | Biotech Hunter | Biotech Hunter