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

Bone Resorption Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334159
• Other study ID #: PER-ECL-2019-08
• Status: Recruiting
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: July 20, 2027

Study information

• Verified date: February 2024
• Source: Universitat Internacional de Catalunya
• Contact: Georgios Markantonatos, DDS
• Phone: +34666022568
• Email: giorgosmark[@]uic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 months.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: July 20, 2027
• Est. primary completion date: July 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women over 18 years old or older

2. 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)

3. One or more teeth missing in posterior zone (Premolars, and Molars)

4. Absence of active Periodontal disease

5. Good level of oral hygiene (Plaque index <25%)

6. Absence of systemic diseases that could influence the outcome of the therapy (Uncontrolled diabetes, osteoporosis, bisphosphonate medications)

7. Non smokers or light smokers (<10 cigarettes per day)

8. Informed consent signed

Exclusion Criteria:

1. Patients with sufficient ridge width (>5 mm) and height (=9mm) from vital anatomical structure) requiring no GBR to place dental implants

2. Patients with severe horizontal and vertical defects requiring other surgical techniques.

3. Long-term non-steroidal anti-inflammatory drug therapy (3months).

4. Lactating females or currently pregnant women.

5. Severe cognitive or psychiatric disorders.

6. Unwillingness to return for follow-up examination.

Related Conditions & MeSH terms

• Bone Resorption

Intervention

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).
• 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).

Locations

Country	Name	City	State
Spain	Georgios Markantonatos	Barcelona	Sant Cugat Del Vallès

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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

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. — View Citation

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 t — View Citation

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. — View Citation

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

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 ?, 2 ?, p. 255-260, ??? 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, ??

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 M — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	T3: 6 months after the Horizontal GBR
Secondary	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	T2-T3: From the surgery to 6 months
Secondary	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).	At 2-weeks follow up after the surgical procedure
Secondary	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	At time of implant placement