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

NCT06334159 | Recruiting

• 1 other identifier: PER-ECL-2019-08
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Resorption

Outcome Measures

Primary Outcomes (2)

• Horizontal Bone Gain

  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 GBR to facilitate implant placement at 6 months. Along the 6 months, 3 Cone Beam Computed Tomography scans (CBCT) will be needed. At baseline (T1), the first CBCT will be taken before performing any surgical procedure to measure the initial width of the ridge. Immediately after the GBR (T2), a second CBCT scan will be taken, which will be useful to measure new ridge width in each group. Finally, at 6 month follow-up a third CBCT scan will be taken (T3) in order to assess the difference with T1 regarding amount of bone gain horizontally, and with T2 regarding horizontal dimensional stability of the grafted bone in each of the 2 groups.

  T3: 6 months after the Horizontal GBR

• Bone Width Gain

  To compare the bone width gain between the test group and control group, 6 months after the horizontal GBR. A caliper will be used in order to evaluate and compare the bone width gain at T1, T2, and T3 between the Test and Control Groups. These measurements are performed intra-operatively before the Horizontal GBR (T1), immediately after (T2), and at 6 months (T3) at the time of implant placement. Measurements will be performed at 1cm, 3cm, and 5cm apical from the bone crest at the regenerated area.

  T3: 6 months after the Horizontal GBR

Secondary Outcomes (4)

• Horizontal Dimensional Stability

  T3: 6 months after the Horizontal GBR

• Post-surgical complications

  T2-T3: From the surgery to 6 months

• Patient's satisfaction

  At 2-weeks follow up after the surgical procedure

• Histologic examination of the augmented bone at 6 months

  At time of implant placement

Study Arms (2)

Control Group

EXPERIMENTAL

Horizontal Guided Bone Regeneration with a mixture of xenograft (Cerabone 0.5-1mm particles) and allograft (Maxgarft \<2mm particles) bone substitute (50/50) with non-fixed resorbable collagen membranes (Jason Membrane 20x30mm)

Procedure: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane

Test Group

EXPERIMENTAL

Horizontal Guided Bone Regeneration with a mixture of xenograft (Cerabone 0.5-1mm particles) and allograft (Maxgarft \<2mm particles) bone substitute (50/50) with fixed resorbable collagen membranes(Jason Membrane 20x30mm) with the use of pins (Titan Pins)

Procedure: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane

Interventions

Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane PROCEDURE

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).

Test Group

Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane PROCEDURE

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).

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Georgios Markantonatos

Barcelona, Sant Cugat Del Vallès, 08195, Spain

RECRUITING

Related Publications (12)

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  PMID: 22737169 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Francis J. Hughes. Stem Cell Biology and Tissue Engineering in Dental Sciences, Academic Press,2015, ISBN 9780123971579: 434-444

  BACKGROUND

• Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

  PMID: 5237684 RESULT

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 RESULT

• Cucchi A, Vignudelli E, Napolitano A, Marchetti C, Corinaldesi G. Evaluation of complication rates and vertical bone gain after guided bone regeneration with non-resorbable membranes versus titanium meshes and resorbable membranes. A randomized clinical trial. Clin Implant Dent Relat Res. 2017 Oct;19(5):821-832. doi: 10.1111/cid.12520. Epub 2017 Jul 26.

  PMID: 28745035 RESULT

• Sisti A, Canullo L, Mottola MP, Covani U, Barone A, Botticelli D. Clinical evaluation of a ridge augmentation procedure for the severely resorbed alveolar socket: multicenter randomized controlled trial, preliminary results. Clin Oral Implants Res. 2012 May;23(5):526-35. doi: 10.1111/j.1600-0501.2011.02386.x. Epub 2011 Dec 8.

  PMID: 22150876 RESULT

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Cristina Vallés, DDS, MS, PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Markantonatos, DDS

CONTACT

+34666022568; giorgosmark@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group)

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 27, 2024
• Study Start: November 5, 2020
• Primary Completion: July 20, 2025
• Study Completion (Estimated): July 20, 2027
• Last Updated: March 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)