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

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).

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Key information

Conditions

Alveolar Bone Preservation Bone Graft

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Persons without periodontal disease

Exclusion criteria

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

Treatment and study plan

Inject BMP

Device

Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.

ExcelOS-inject

Device

Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.

Primary outcomes

compared the changed height and standard height by computed tomography.

Time frame: at 12 weeks after surgery

Sponsors and collaborators

Lead sponsor

BioAlpha Inc.

Industry

Registry information

Official study title

Clinical Study to Evaluate Efficacy and Safety of "Inject BMP(Beta-TCP Containing rhBMP-2)" for Socket Preservation After Extraction of a Single-rooted Tooth: A Randomized, Outcomes Assessor-Blinded, Multi-center, Prospective Trial.

Acronym: rhBMP-2

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Mar 22, 2016
Registry last updated: Apr 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting