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A multicenter randomized controlled clinical trial using a new resorbable non‐cross‐linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure

Identifieur interne : 000B11 ( Main/Exploration ); précédent : 000B10; suivant : 000B12

A multicenter randomized controlled clinical trial using a new resorbable non‐cross‐linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure

Auteurs : Bastian Wessing ; Istvan Urban ; Eduardo Montero ; Werner Zechner ; Markus Hof ; Javier Alández Chamorro ; Nuria Alández Martin ; Giovanni Polizzi ; Silvio Meloni ; Mariano Sanz

Source :

Clinical Oral Implants Research [ 0905-7161 ] ; 2016.

RBID : PMC:5697637

Abstract

AbstractObjective

To compare clinical performance of a new resorbable non‐cross‐linked collagen membrane, creos xenoprotect (CXP), with a reference membrane (BG) for guided bone regeneration at dehisced implant sites.

Materials and methods

This randomized controlled clinical trial enrolled patients with expected dehiscence defects following implant placement to restore single teeth in the maxillary and mandibular esthetic zone and premolar area. Implants were placed using a two‐stage surgical protocol with delayed loading. Bone augmentation material placed at the implant surface was immobilized with CXP or BG membrane. Soft tissue health was followed during the healing period, and the defect size was measured at reentry and 6 months after implant placement.

Results

Of the 49 included patients, 24 were treated with CXP and 25 with BG. Patient characteristics did not differ between the two arms. In the CXP arm, the defect height at implant insertion was (mean ± SD) 5.1 ± 2.1 mm (n = 24) and reduced at reentry by 81% to 1.0 ± 1.3 mm (n = 23). In the BG arm, the defect height at implant insertion was 4.9 ± 1.9 mm (n = 25) and reduced at reentry by 62% to 1.7 ± 2.1 mm (n = 24). Assuming a margin of non‐inferiority of 1 mm, CXP was non‐inferior to BG. Membrane exposure rate was highest at week 3 in both arms, reaching 16.7% for BG and 8.7% for CXP.

Conclusions

The new resorbable non‐cross‐linked collagen membrane facilitates bone gain to support implant placement in expected dehiscence defects. The observed trend toward higher mean bone gain and lower exposure rate with CXP compared to BG should be further investigated.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5697637

DOI: 10.1111/clr.12995
PubMed: 27990692
PubMed Central: 5697637

Affiliations:

Le document en format XML

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<front><div type="abstract" xml:lang="en"><title>Abstract</title>
<sec id="clr12995-sec-0001"><title>Objective</title>
<p>To compare clinical performance of a new resorbable non‐cross‐linked collagen membrane, creos xenoprotect (<styled-content style="fixed-case">CXP</styled-content>
), with a reference membrane (<styled-content style="fixed-case">BG</styled-content>
) for guided bone regeneration at dehisced implant sites.</p>
</sec>
<sec id="clr12995-sec-0002"><title>Materials and methods</title>
<p>This randomized controlled clinical trial enrolled patients with expected dehiscence defects following implant placement to restore single teeth in the maxillary and mandibular esthetic zone and premolar area. Implants were placed using a two‐stage surgical protocol with delayed loading. Bone augmentation material placed at the implant surface was immobilized with <styled-content style="fixed-case">CXP</styled-content>
 or <styled-content style="fixed-case">BG</styled-content>
 membrane. Soft tissue health was followed during the healing period, and the defect size was measured at reentry and 6 months after implant placement.</p>
</sec>
<sec id="clr12995-sec-0003"><title>Results</title>
<p>Of the 49 included patients, 24 were treated with <styled-content style="fixed-case">CXP</styled-content>
 and 25 with <styled-content style="fixed-case">BG</styled-content>
. Patient characteristics did not differ between the two arms. In the <styled-content style="fixed-case">CXP</styled-content>
 arm, the defect height at implant insertion was (mean ± <styled-content style="fixed-case">SD</styled-content>
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 = 23). In the <styled-content style="fixed-case">BG</styled-content>
 arm, the defect height at implant insertion was 4.9 ± 1.9 mm (<italic>n</italic>
 = 25) and reduced at reentry by 62% to 1.7 ± 2.1 mm (<italic>n</italic>
 = 24). Assuming a margin of non‐inferiority of 1 mm, <styled-content style="fixed-case">CXP</styled-content>
 was non‐inferior to <styled-content style="fixed-case">BG</styled-content>
. Membrane exposure rate was highest at week 3 in both arms, reaching 16.7% for <styled-content style="fixed-case">BG</styled-content>
 and 8.7% for <styled-content style="fixed-case">CXP</styled-content>
.</p>
</sec>
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<p>The new resorbable non‐cross‐linked collagen membrane facilitates bone gain to support implant placement in expected dehiscence defects. The observed trend toward higher mean bone gain and lower exposure rate with <styled-content style="fixed-case">CXP</styled-content>
 compared to <styled-content style="fixed-case">BG</styled-content>
 should be further investigated.</p>
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A multicenter randomized controlled clinical trial using a new resorbable non‐cross‐linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure

A multicenter randomized controlled clinical trial using a new resorbable non‐cross‐linked collagen membrane for guided bone regeneration at dehisced single implant sites: interim results of a bone augmentation procedure

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