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Comparison of a polyethylene glycol membrane and a collagen membrane for the treatment of bone dehiscence defects at bone level implants-A prospective, randomized, controlled, multicenter clinical trial


Jung, Ronald Ernst; Mihatovic, Ilja; Cordaro, Luca; Windisch, Péter; Friedmann, Anton; Blanco Carrion, Juan; Sanz Sanchez, Ignacio; Hallman, Mats; Quirynen, Marc; Hammerle, Christoph H F (2020). Comparison of a polyethylene glycol membrane and a collagen membrane for the treatment of bone dehiscence defects at bone level implants-A prospective, randomized, controlled, multicenter clinical trial. Clinical Oral Implants Research, 31(11):1105-1115.

Abstract

OBJECTIVES
The aim of the present randomized, controlled clinical multicenter trial was to compare a polyethylene glycol (PEG) and a native collagen membrane (BG) for simultaneous guided bone regeneration at bony dehiscence-type defects around bone level titanium implants.
MATERIAL AND METHODS
The study enrolled 117 patients requiring implant treatment in the posterior maxilla or mandible with expected buccal bony dehiscence-type defects at the placed titanium implants. According to a parallel groups design, defects were filled with a synthetic bone filler and randomly assigned to either PEG or BG membrane. As primary parameter, the relative vertical bone fill was assessed at baseline and at re-entry after 6 months of healing. As secondary parameters, the marginal bone level (MBL) was assessed radiographically and soft tissue conditions were recorded up to 18 months postloading.
RESULTS
Both groups showed comparable vertical bone fill revealing a relative change in defect height of 59.7% (PEG) and 64.4% (BG). The absolute mean reduction in defect size was 2.5 mm in the PEG group and 3.2 mm in the BG group. Although both groups revealed a statistically significant mean defect reduction (p < .001), a comparison between the two groups did not show statistical significances. The non-inferiority test with inferiority limit of -5% could not be rejected, based on the 90% confidence interval of the differences of the two means with lower limit -15.4%. After 18 months, an MBL increase of 0.45 ± 0.43 mm in the PEG group and 0.41 ± 0.81 mm in the BG group was detected (p < .001). Soft tissue complications were observed in both groups without showing statistical significance.
CONCLUSIONS
Both membranes supported bone regeneration at dehiscence-type defects and obtained vertical bone fill with a relative change in defect height of 59.7% (PEG) and 64.4% (BG); however, the non-inferiority of PEG could not be shown.

Abstract

OBJECTIVES
The aim of the present randomized, controlled clinical multicenter trial was to compare a polyethylene glycol (PEG) and a native collagen membrane (BG) for simultaneous guided bone regeneration at bony dehiscence-type defects around bone level titanium implants.
MATERIAL AND METHODS
The study enrolled 117 patients requiring implant treatment in the posterior maxilla or mandible with expected buccal bony dehiscence-type defects at the placed titanium implants. According to a parallel groups design, defects were filled with a synthetic bone filler and randomly assigned to either PEG or BG membrane. As primary parameter, the relative vertical bone fill was assessed at baseline and at re-entry after 6 months of healing. As secondary parameters, the marginal bone level (MBL) was assessed radiographically and soft tissue conditions were recorded up to 18 months postloading.
RESULTS
Both groups showed comparable vertical bone fill revealing a relative change in defect height of 59.7% (PEG) and 64.4% (BG). The absolute mean reduction in defect size was 2.5 mm in the PEG group and 3.2 mm in the BG group. Although both groups revealed a statistically significant mean defect reduction (p < .001), a comparison between the two groups did not show statistical significances. The non-inferiority test with inferiority limit of -5% could not be rejected, based on the 90% confidence interval of the differences of the two means with lower limit -15.4%. After 18 months, an MBL increase of 0.45 ± 0.43 mm in the PEG group and 0.41 ± 0.81 mm in the BG group was detected (p < .001). Soft tissue complications were observed in both groups without showing statistical significance.
CONCLUSIONS
Both membranes supported bone regeneration at dehiscence-type defects and obtained vertical bone fill with a relative change in defect height of 59.7% (PEG) and 64.4% (BG); however, the non-inferiority of PEG could not be shown.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Center for Dental Medicine > Clinic of Reconstructive Dentistry
Dewey Decimal Classification:610 Medicine & health
Scopus Subject Areas:Health Sciences > Oral Surgery
Language:English
Date:November 2020
Deposited On:05 Jan 2021 14:05
Last Modified:06 Jan 2021 21:00
Publisher:Wiley-Blackwell Publishing, Inc.
ISSN:0905-7161
Additional Information:This is the peer reviewed version of the following article: Jung, Ronald Ernst; Mihatovic, Ilja; Cordaro, Luca; Windisch, Péter; Friedmann, Anton; Blanco Carrion, Juan; Sanz Sanchez, Ignacio; Hallman, Mats; Quirynen, Marc; Hammerle, Christoph H F (2020) Comparison of a polyethylene glycol membrane and a collagen membrane for the treatment of bone dehiscence defects at bone level implants-A prospective, randomized, controlled, multicenter clinical trial. Clinical Oral Implants Research, 31(11):1105-1115, which has been published in final form at https://doi.org/ 10.1111/clr.13657. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. (http://www.wileyauthors.com/self-archiving)
OA Status:Closed
Publisher DOI:https://doi.org/10.1111/clr.13657
PubMed ID:32875638

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