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Recruiting NCT06334159

Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes

No phase Interventional Bone Resorption

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane, Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane.
Who it may be relevant to
Registry conditions: Bone Resorption. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Guided Bone Regeneration Using Fixed vs Non-Fixed Resorbable Collagen Membranes: A Randomized Controlled Clinical Trial

Overview

The aim of this clinical trial is to compare the horizontal bone gain when grafting a bone substitute with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Detailed description

The aim of this clinical trial is to compare the horizontal bone gain when grafting a mixture of xenograft and allograft (50/50) with non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group) in resorbed ridges requiring Guided Bone Regeneration (GBR) to facilitate implant placement at 6 months.

Interventions

  • Procedure Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane
    Horizontal Guided Bone Regeneration, with a mixture of xenograft (Cerabone®) and allograft (Maxgraft®), on a 50-50 mixture ratio, grafted in the area required to be augmented, and then covered by a collagen membrane (Jason® membrane), being fixed with non-resorbable pins (Test Group).
  • Procedure Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane
    Horizontal Guided Bone Regeneration, with a mixture of xenograft (Cerabone®) and allograft (Maxgraft®), on a 50-50 mixture ratio, grafted in the area required to be augmented, and then covered by a collagen membrane (Jason® membrane), being left unfixed (Control Group).

Primary outcome measures

  • Horizontal Bone Gain [Time frame: T3: 6 months after the Horizontal GBR]
  • Bone Width Gain [Time frame: T3: 6 months after the Horizontal GBR]
Secondary outcome measures (4)
  • Horizontal Dimensional Stability [Time frame: T3: 6 months after the Horizontal GBR]
  • Post-surgical complications [Time frame: T2-T3: From the surgery to 6 months]
  • Patient's satisfaction [Time frame: At 2-weeks follow up after the surgical procedure]
  • Histologic examination of the augmented bone at 6 months [Time frame: At time of implant placement]

Eligibility criteria

Inclusion criteria

  • Men and women over 18 years old or older
  • Patients requiring Guided Bone Regeneration due to insufficient ridge width(≤5mm) to place dental implants, with sufficient vertical ridge height (≥9mm) from vital anatomical structures (the inferior alveolar nerve in the Mandible, or the sinus in the Maxilla)
  • One or more teeth missing in posterior zone (Premolars, and Molars)
  • Absence of active Periodontal disease
  • Good level of oral hygiene (Plaque index <25%)
  • Absence of systemic diseases that could influence the outcome of the therapy (Uncontrolled diabetes, osteoporosis, bisphosphonate medications)
  • Non smokers or light smokers (<10 cigarettes per day)
  • Informed consent signed

Exclusion criteria

  • Patients with sufficient ridge width (>5 mm) and height (≥9mm) from vital anatomical structure) requiring no GBR to place dental implants
  • Patients with severe horizontal and vertical defects requiring other surgical techniques.
  • Long-term non-steroidal anti-inflammatory drug therapy (3months).
  • Lactating females or currently pregnant women.
  • Severe cognitive or psychiatric disorders.
  • Unwillingness to return for follow-up examination.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Georgios Markantonatos — Barcelona

Publications

  • Pagni G, Pellegrini G, Giannobile WV, Rasperini G. Postextraction alveolar ridge preservation: biological basis and treatments. Int J Dent. 2012;2012:151030. doi: 10.1155/2012/151030. Epub 2012 Jun 12. PMID 22737169
  • Paolantonio M, Dolci M, Scarano A, d'Archivio D, di Placido G, Tumini V, Piattelli A. Immediate implantation in fresh extraction sockets. A controlled clinical and histological study in man. J Periodontol. 2001 Nov;72(11):1560-71. doi: 10.1902/jop.2001.72.11.1560. PMID 11759868
  • Hua Wang, Chunfu Deng, Baohong Zhao, Dehao Shang, Chong Zhang, The Effect of Bone Formation with Bio-Oss Guided by Collagen Membrane, Journal of Hard Tissue Biology, 2013, 22 巻, 2 号, p. 255-260, 公開日 2013/04/26, Online ISSN 1880-828X, Print ISSN 1341-7649, https://doi.org/10.2485/jhtb.22.255, https://www.jstage.jst.go.jp/article/jhtb/22/2/22_255/_article/-char/ja, 抄録
  • Lee SW, Kim SG. Membranes for the Guided Bone Regeneration. Maxillofac Plast Reconstr Surg. 2014 Nov;36(6):239-46. doi: 10.14402/jkamprs.2014.36.6.239. Epub 2014 Nov 12. PMID 27489841
  • Dimitriou R, Mataliotakis GI, Calori GM, Giannoudis PV. The role of barrier membranes for guided bone regeneration and restoration of large bone defects: current experimental and clinical evidence. BMC Med. 2012 Jul 26;10:81. doi: 10.1186/1741-7015-10-81. PMID 22834465
  • Urban IA, Lozada JL, Wessing B, Suarez-Lopez del Amo F, Wang HL. Vertical Bone Grafting and Periosteal Vertical Mattress Suture for the Fixation of Resorbable Membranes and Stabilization of Particulate Grafts in Horizontal Guided Bone Regeneration to Achieve More Predictable Results: A Technical Report. Int J Periodontics Restorative Dent. 2016 Mar-Apr;36(2):153-9. doi: 10.11607/prd.2627. PMID 26901293
  • Amano Y, Ota M, Sekiguchi K, Shibukawa Y, Yamada S. Evaluation of a poly-l-lactic acid membrane and membrane fixing pin for guided tissue regeneration on bone defects in dogs. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Feb;97(2):155-63. doi: 10.1016/j.tripleo.2003.09.009. PMID 14970774
  • Francis J. Hughes. Stem Cell Biology and Tissue Engineering in Dental Sciences, Academic Press,2015, ISBN 9780123971579: 434-444

Identifiers

NCT: NCT06334159 · PER-ECL-2019-08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗