Evidence map›Paper›PMID 36387954›Full record

ArticleBMJ open science2022

Preclinical safety study of nacre powder in an intraosseous sheep model.

Donata Iandolo, Norbert Laroche, Dung Kim Nguyen, Miriam Normand, Christophe Met, Ganggang Zhang, Laurence Vico, Didier Mainard, Marthe Rousseau

Erratum issuedAbstract read
In one paragraph

Article in BMJ open science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Bioengineering (Basel, Switzerland) · 2024
    Article
  4. Article
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Donata IandoloU1059 SAINBIOSE, INSERM, Jean Monnet University, University of Lyon, Mines Saint-Etienne, Saint-Priest-en-Jarez, France.ORCID 0000-0002-8090-8427
Norbert LarocheU1059 SAINBIOSE, INSERM, Jean Monnet University, University of Lyon, Mines Saint-Etienne, Saint-Priest-en-Jarez, France.
Dung Kim NguyenU1059 SAINBIOSE, INSERM, Jean Monnet University, University of Lyon, Mines Saint-Etienne, Saint-Priest-en-Jarez, France.ORCID 0000-0002-5160-3114
Miriam NormandU1059 SAINBIOSE, INSERM, Jean Monnet University, University of Lyon, Mines Saint-Etienne, Saint-Priest-en-Jarez, France.
Christophe Met88, allée de Signes résidence, Sainte-Baume, Plan-d'Aups-Sainte-Baume, France.
Ganggang ZhangDepartment of Orthopedics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Laurence VicoU1059 SAINBIOSE, INSERM, Jean Monnet University, University of Lyon, Mines Saint-Etienne, Saint-Priest-en-Jarez, France.
Didier MainardUMR7365 IMoPA, CNRS/Lorraine University, Nancy, France.
Marthe RousseauU1059 SAINBIOSE, INSERM, Jean Monnet University, University of Lyon, Mines Saint-Etienne, Saint-Priest-en-Jarez, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: The purpose of this preclinical study was to evaluate the safety, the local tissue effects and bone healing performance (osteoconduction, osseointegration) of nacre powder in a sheep intraosseous implantation model. This represents the first preclinical study to assess nacre safety and efficacy in supporting new bone formation in accordance with the ISO 10993 standard for biomedical devices. Methods: The local tissue effects and the material performance were evaluated 8 weeks after implantation by qualitative macroscopic observation and qualitative as well as semiquantitative microscopic analyses of the bone sites. Histopathological characterisations were run to assess local tissue effects. In addition, microarchitectural, histomorphometric and histological characterisations were used to evaluate the effects of the implanted material. Results: Nacre powder was shown to cause a moderate inflammatory response in the site where it was implanted compared with the sites left empty. The biomaterial implanted within the generated defects was almost entirely degraded over the investigated time span and resulted in the formation of new bone with a seamless connection with the surrounding tissue. On the contrary, in the empty defects, the formation of a thick compact band of sclerotic bone was observed by both microarchitectural and histological characterisation. Conclusions: Nacre powder was confirmed to be a safe biomaterial for bone regeneration applications in vivo, while supporting bone formation.

Indexed as

Biomedical ResearchModels, AnimalSheep

Identifiers

PMID36387954
PMCPMC9644736

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.