Evidence map›Paper›PMID 36707442›Full record

Trial reportClinical oral investigations2023

Randomized clinical study of injectable dextrin-based hydrogel as a carrier of a synthetic bone substitute.

Alexandra Machado, Isabel Pereira, Filomena Costa, Ana Brandão, José Eduardo Pereira, Ana Colette Maurício, José Domingos Santos, Inês Amaro, Rui Falacho, Rui Coelho and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical oral investigations, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Hydrogels in Oral Disease Management: A Review of Innovations in Drug Delivery and Tissue Regeneration.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Alexandra MachadoCEB, Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.
Isabel PereiraCEB, Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.
Filomena CostaCEB, Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal.
Ana BrandãoBiosckin, Molecular and Cell Therapies S.A., TecMaia, Rua Engenheiro Frederico Ulrich 2650, 4470-605, Maia, Portugal.
José Eduardo PereiraCECAV, Animal and Veterinary Research Centre, University of Trás-os-Montes and Alto Douro, 5001-801, Vila Real, Portugal.
Ana Colette MaurícioDepartamento de Clínicas Veterinárias, Instituto de Ciências Biomédicas de Abel Salazar (ICBAS), Universidade do Porto (UP), Rua de Jorge Viterbo Ferreira, N° 228, 4050-313, Porto, Portugal.
José Domingos SantosREQUIMTE/LAQV, Departamento de Engenharia Metalúrgica e Materiais, Faculdade de Engenharia, Universidade do Porto, Rua Dr. Roberto Frias, 4200-495, Porto, Portugal.
Inês AmaroInstitute of Integrated Clinical Practice, Faculty of Medicine, University of Coimbra, 3004-504, Coimbra, Portugal.
Rui FalachoInstitute of Oral Implantology and Prosthodontics, Faculty of Medicine, University of Coimbra, 3004-504, Coimbra, Portugal.
Rui CoelhoRESDEVMED, Unipessoal Lda., Travessa do Navega, 436 C, 3885-183, Ovar, Portugal.
Nuno CruzFaculty of Dentistry, Universitat Internacional de Catalunya, 08017, Barcelona, Spain.
Miguel GamaCEB, Centre of Biological Engineering, University of Minho, Campus de Gualtar, 4710-057, Braga, Portugal. fmgama@deb.uminho.pt.ORCID http://orcid.org/0000-0002-5655-0015

Funding

Fundação para a Ciência e a Tecnologia SFRH/BD/132000/2017
6 · The paper itself

Abstract

objectivesThis study aimed to improve the performance and mode of administration of a glass-reinforced hydroxyapatite synthetic bone substitute, Bonelike by Biosckin® (BL®), by association with a dextrin-based hydrogel, DEXGEL, to achieve an injectable and moldable device named DEXGEL Bone.

methodsTwelve participants requiring pre-molar tooth extraction and implant placement were enrolled in this study. BL® granules (250-500 µm) were administered to 6 randomized participants whereas the other 6 received DEXGEL Bone. After 6 months, a bone biopsy of the grafted area was collected for histological and histomorphometric evaluation, prior to implant placement. The performance of DEXGEL Bone and BL® treatments on alveolar preservation were further analyzed by computed tomography and Hounsfield density analysis. Primary implant stability was analyzed by implant stability coefficient technique.

resultsThe healing of defects was free of any local or systemic complications. Both treatments showed good osseointegration with no signs of adverse reaction. DEXGEL Bone exhibited increased granule resorption (p = 0.029) accompanied by a tendency for more new bone ingrowth (although not statistically significant) compared to the BL® group. The addition of DEXGEL to BL® granules did not compromise bone volume or density, being even beneficial for implant primary stability (p = 0.017).

conclusionsThe hydrogel-reinforced biomaterial exhibited an easier handling, a better defect filling, and benefits in implant stability. CLINICAL RELEVANCE: This study validates DEXGEL Bone safety and performance as an injectable carrier of granular bone substitutes for alveolar ridge preservation.

trial registrationEuropean Databank on Medical Devices (EUDAMED) No. CIV-PT-18-01-02,705; Registo Nacional de Estudos Clínicos, RNEC, No. 30122.

Indexed as

Alveolar Bone LossAlveolar Ridge AugmentationBone SubstitutesDextrinsHumansHydrogelsOsseointegrationTooth ExtractionTooth SocketBone SubstitutesDextrinsHydrogelsAlveolar preservationDextrinInjectable hydrogelSynthetic bone

Identifiers

PMID36707442
PMCPMC9985577

What OpenQuestion holds

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Registered trials

None linked

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.