Dental implants
Ridge Preservation Using Demineralized Bone Matrix Gel With Recombinant Human Bone Morphogenetic Protein-2 After Tooth Extraction: A Randomized Controlled Clinical Trial

https://doi.org/10.1016/j.joms.2014.01.022Get rights and content

Purpose

The aim of the present randomized controlled trial was to determine the safety and efficacy of injectable demineralized bone matrix (DBM) gel combined with recombinant human bone morphogenetic protein-2 (rhBMP-2) on alveolar ridge preservation after tooth extraction.

Materials and Methods

A total of 69 patients were randomly assigned to either a test group (n = 35) or a control group (n = 34). In the test group, DBM, together with rhBMP-2 (0.05 mg/mL; rhBMP-2/DBM) was transplanted into the extraction sockets. The control group received DBM alone. The safety of rhBMP-2/DBM was evaluated by oral examination, serum chemistry, and hematologic examination. The radiographic changes in alveolar bone height and width were measured using computed tomography scans performed immediately after transplant and again 3 months thereafter.

Results

Healing was uneventful in all subjects, with no anticipated adverse events and no clinically significant changes in the serum chemistry and hematologic findings. No meaningful immune response was found among the study groups. No significant difference was found in the radiographic changes of alveolar bone height and width (P > .05).

Conclusions

This new injectable biomaterial can be used easily and safely in clinical applications.

Section snippets

Study Population and Design

The present single-blind, prospective, and parallel-arm RCT was conducted at 2 centers in the Republic of Korea from April 2011 to March 2013, and the study protocol was approved by the institutional review board at each of the 2 study centers (approval nos. 2-2010-0004, MD09019). The present study was conducted with the approval of the Korean Food and Drug Association. This clinical trial was registered at http://cris.nih.go.kr/cris/index.jsp.

All patients aged 20 to 70 years, who required

Results

Patient flow through the study is shown in Figure 4. A total of 78 patients were initially screened, and 69 eligible patients were randomly allocated at surgery (visit 2) into the test group (n = 35) or control group (n = 34). Six subjects were withdrawn or lost during the follow-up period (Table 1). Although the radiologic data of another 6 patients were not of diagnostic quality, their clinical parameters were included in the safety assessment.

Discussion

In the present study, the application of rhBMP-2 using injectable DBM gel into the extraction socket successfully preserved the volume of the alveolar ridge, and its clinical safety was well demonstrated. In addition, no adverse reactions to the graft material, including rhBMP-2, were observed.

The experimental model in the ridge preservation procedure after extraction is a well-established study design and has been used in a number of studies.22 In the present study, the extraction sockets with

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    The present study was supported by a faculty research grant from Yonsei University College of Dentistry for 2011 (grant 6-2011-0051).

    Drs Kim, Shin, and Cho contributed equally to this work and they are co-corresponding authors.

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    Copyright © 2014 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.