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Bone ResorptionNCT06334159

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

A study testing Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane and Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane in people with Bone Resorption, run by Universitat Internacional de Catalunya at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bone Resorption
What is being tested?
Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane and Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSpain
Study dates
5 Nov 2020to 20 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Georgios Markantonatos, DDS contact

+34666022568

giorgosmark@uic.es

Spain1 site, 1 recruiting

  • Georgios Markantonatos

    Barcelona, Sant Cugat Del Vallès, 08195

    Georgios Markantonatos, DDS, +34666022568, giorgosmark@uic.es

    Cristina Vallès, DDS, MS, PhD

    Recruiting

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions
Bone Resorption
Being tested
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
Medical subject headings
Bone Resorption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membraneProcedure or surgery

    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).

  • Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membraneProcedure or surgery

    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).

Study groups in NCT06334159
Study groupRoleWhat they receive
Control GroupExperimentalHorizontal 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)
Receives: Procedure: Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane
Test GroupExperimentalHorizontal 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)
Receives: Procedure: Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: T3: 6 months after the Horizontal GBR

  2. 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.

    Measured: T3: 6 months after the Horizontal GBR

Secondary outcomes (4)

  1. Horizontal Dimensional Stability

    To compare the horizontal dimensional stability of the augmented ridges between the test group and control group after 6 months.

    After the surgical procedure, a CBCT scan (T2) will be completed and the bone width will be assessed and compared with the bone width at 6 months postoperatively when a new CBCT scan (T3) will be completed before implant placement.

    Measured: T3: 6 months after the Horizontal GBR

  2. Post-surgical complications

    To compare the post-surgical complications that may occur between the test group and control group throughout the period of healing and during the following 6 months. The complications will be evaluated using the Healing Complications Classification, as suggested by Fontana et al. 2011. The healing post-surgical complications are divided into four classes, according to the presence and extent of exposure, as well as the presence of a purulent exudate:

    • Class I: membrane exposure <3mm, no purulent exudate
    • Class II: membrane exposure ≥3mm, no purulent exudate
    • Class III: membrane exposure with purulent exudate
    • Class IV: abscess, without membrane exposure

    Measured: T2-T3: From the surgery to 6 months

  3. Patient's satisfaction

    To compare patient's satisfaction regarding the post-operative pain and compare it between the test group and control group throughout the period of healing and during the following 6 months, through the use of a Visual Analogue Scale (VAS). It is a 10cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients will be asked to mark their average experience of discomfort and pain. The scores of the VAS will be obtained by measuring the distance in centimeters (0 to 10).

    Measured: At 2-weeks follow up after the surgical procedure

  4. Histologic examination of the augmented bone at 6 months

    To examine type of cells present after 6 months of procedure by performing histological examination to the sample harvested from the site with the use of an implant trephine drill. The histologic evaluation will be performed in order to evaluate the type of cells present at the site of augmentation

    Measured: At time of implant placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start5 Nov 2020
  3. Primary completion20 Jul 2025 (estimated)
  4. Study completion20 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
non fixed resorbable collagen membranes (control group), versus fixed resorbable collagen membranes (test group)
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06334159
Sponsor's protocol ID
PER-ECL-2019-08
Status last verified
Feb 2024
First submitted
19 Feb 2024
Last updated
27 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 14970774

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

  • 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.

    PubMed 5237684

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

    PubMed 1058834

  • 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.

    PubMed 28745035

  • 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.

    PubMed 22150876

Questions about this trial

What is this clinical trial studying?

A study testing Horizontal GBR with the use of non-resorbable pins for the stabilization of the collagen membrane and Horizontal GBR without the use of non-resorbable pins for the stabilization of the collagen membrane in people with Bone Resorption, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Georgios Markantonatos, DDS (+34666022568, giorgosmark@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Horizontal Bone Gain (time frame: T3: 6 months after the Horizontal GBR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06334159, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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