Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2

BioAlpha

Status: Completed

Conditions: Alveolar Bone Preservation; Bone Graft

Treatments: Device: Inject BMP; Device: ExcelOS-inject

Study type: Interventional

Funder types: Industry

Identifiers

NCT02714829

ExcelOS 14-01

Details and patient eligibility

About

This is a prospective, outcomes assessor-blinded, randomized study to evaluate the efficacy and safety of "Inject BMP(Injectable Ceramics Bone Graft Substitute Containing rhBMP-2)" for socket preservation after extraction of a single-rooted tooth, compared to ExcelOS-inject(Injectable Ceramics Bone Graft Substitute).

Full description

Inject BMP is Injectable Ceramics Bone Graft Substitute(ExcelOS-inject) containing rhBMP-2. Recombinant human Bone morphogenetic protein 2 (rhBMP-2) stimulates the production of bone.

Enrollment: 88 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persons without periodontal disease

Exclusion criteria

• Women who are pregnant or plan to be pregnant within study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

Inject BMP

Experimental group

Description:

ExcelOS-inject containing rhBMP-2

Treatment:

Device: Inject BMP

ExcelOS-inject

Active Comparator group

Description:

ExcelOS-inject without rhBMP-2

Treatment:

Device: ExcelOS-inject