Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla

Guided Bone Regeneration Clinical Trial

Official title:

Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla Using Native Collagen vs Titanium Reinforced Polytetraflouroethelene Membranes Using an Organic Bovine Bone Mineral

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03840681
• Other study ID #: MMetwally
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2019
• Est. completion date: September 2019

Study information

• Verified date: February 2019
• Source: Cairo University
• Contact: Mohab f Metwally
• Phone: 00201115709990
• Email: hobaz90_2000[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Guided bone regeneration (GBR) is a surgical technique that uses barrier membranes to promote osteoblast cells proliferation and exclude other cells such as epithelium and connective tissue cells. GBR is often combined with bone grafting procedures.

Using Absorbable membranes like collagen membrane will reduce treatment time by decreasing need for second surgery

Description:

Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla using native Collagen vs Titanium Reinforced Polytetraflouroethelene Membranes using an organic bovine Bone mineral.Reconstructive surgery is necessary before implant placement to regenerate bone defects caused by atrophy, dental trauma, extractions or periodontal disease . Success rate of implants is related to the correct position and angulation of implants in residual crest, so that height and thickness of bone augmentation can allow predictable results ,With this in mind, it is important to establish sound clinical concepts with clearly defined parameters that lead to successful esthetics in the anterior maxilla, with long-term stability of the peri-implant tissues.

The most popular surgical procedures to obtain bone augmentation are: bone grafts, guided bone regeneration, maxillary sinus floor elevation, and bone osteogenesis distraction.

Guided bone regeneration (GBR) is a surgical technique that uses barrier membranes to promote osteoblast cells proliferation and exclude other cells such as epithelium and connective tissue cells. GBR is often combined with bone grafting procedures.

Bone grafts are integrated into native bone with three different processes: osteogenesis, osteoinduction and osteoconduction; Osteogenesis is the formation of new bone from osteocompetent cells and is the only process where the graft itself can induce Bone augmentation, Osteoinduction induces Bone Augmentation from the differentiation and stimulation of mesenchymal cells by the bone-inductive proteins, Osteoconduction is the formation of Bone Augmentation along a scaffold from osteocompetent cells of the recipient site .

There are 2 Types of membranes:

III. Non Resorbable membrane IV. Resorbable membrane

Non-resorbable membranes:

With the presentation of the first successful GBR procedures and the subsequent wide and successful application of ePTFE membranes, this material became a standard for bone regeneration. Expanded PTFE is characterized as a polymer with high stability in biological systems. It resists breakdown by host tissues and by microbes and does not elicit immunologic reactions. A frequent complication with membrane application in conjunction with implants is membrane exposure and infection Wound dehiscence and membrane exposure have been reported to impair the amount of bone regenerated in a number of experimental animal and clinical investigations

Bioresorbable membranes:

The requirement of second surgical procedure for the removal of Non Resorbable barrier membrane(NRBM) led to the introduction of bioresorbable barrier membranes (RBM). The advantages of RBM compared to NRBM were as follows:

1. Improved soft tissue healing,

2. Incorporation of the membranes by the host tissues (depending on material properties),

3. Quick resorption in case of exposure, eliminating bacterial contamination. Today, a lot of RBM are commercially available including collagen, freeze-dried fascia lata, freeze-dried dura mater allografts, polyglactin-acid, polylactic acid, polyglycolic acid, polyorthoester, polyurethane, polyhydroxybutyrate, etc.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Patients with atrophied anterior maxillary ridge area.

• Age: 18 years and older.

• No intraoral soft and hard tissue pathology.

• No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

• Heavy smokers more than 20 cigarettes per day.(32)

• Patients with systemic disease that may affect normal healing.

• Psychiatric problems.

• Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.

• Pregnant or nursing women.

• Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.

• Patient with previous history of radiotherapy.

Related Conditions & MeSH terms

• Guided Bone Regeneration

Intervention

Other:
• Augmentation
non invasive technique to increase bone width and eliminate need for second surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (14)

Becker W, Dahlin C, Becker BE, Lekholm U, van Steenberghe D, Higuchi K, Kultje C. The use of e-PTFE barrier membranes for bone promotion around titanium implants placed into extraction sockets: a prospective multicenter study. Int J Oral Maxillofac Implants. 1994 Jan-Feb;9(1):31-40. — View Citation

Chiapasco M, Zaniboni M, Boisco M. Augmentation procedures for the rehabilitation of deficient edentulous ridges with oral implants. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:136-59. Review. — View Citation

Elgali I, Omar O, Dahlin C, Thomsen P. Guided bone regeneration: materials and biological mechanisms revisited. Eur J Oral Sci. 2017 Oct;125(5):315-337. doi: 10.1111/eos.12364. Epub 2017 Aug 19. Review. — View Citation

Esposito M, Grusovin MG, Coulthard P, Worthington HV. The efficacy of various bone augmentation procedures for dental implants: a Cochrane systematic review of randomized controlled clinical trials. Int J Oral Maxillofac Implants. 2006 Sep-Oct;21(5):696-710. Review. — View Citation

Gher ME, Quintero G, Assad D, Monaco E, Richardson AC. Bone grafting and guided bone regeneration for immediate dental implants in humans. J Periodontol. 1994 Sep;65(9):881-91. — View Citation

Gotfredsen K, Nimb L, Buser D, Hjørting-Hansen E. Evaluation of guided bone generation around implants placed into fresh extraction sockets: an experimental study in dogs. J Oral Maxillofac Surg. 1993 Aug;51(8):879-84; discussion 885-6. — View Citation

Hoexter DL. Bone regeneration graft materials. J Oral Implantol. 2002;28(6):290-4. Review. — View Citation

Hutmacher D, Hürzeler MB, Schliephake H. A review of material properties of biodegradable and bioresorbable polymers and devices for GTR and GBR applications. Int J Oral Maxillofac Implants. 1996 Sep-Oct;11(5):667-78. Review. — View Citation

Karring T, Cortellini P, Lindhe J. Regenerative periodontal therapy. In: Lindhe J, Karring T, Lang NP, editors. Clinical periodontology and implant dentistry. Copenhagen: Munksgaard, 1997: 597-646.

Kohal RJ, Trejo PM, Wirsching C, Hürzeler MB, Caffesse RG. Comparison of bioabsorbable and bioinert membranes for guided bone regeneration around non-submerged implants. An experimental study in the mongrel dog. Clin Oral Implants Res. 1999 Jun;10(3):226-37. — View Citation

Lopez MA, Andreasi Bassi M, Confalone L, Carinci F. REGENERATION OF ATROPHIC CRESTAL RIDGES WITH RESORBABLE LAMINA: TECHNICAL NOTE. J Biol Regul Homeost Agents. 2015 Jul-Sep;29(3 Suppl 1):97-100. — View Citation

McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. Review. — View Citation

Schliephake H, Kracht D. Vertical ridge augmentation using polylactic membranes in conjunction with immediate implants in periodontally compromised extraction sites: an experimental study in dogs. Int J Oral Maxillofac Implants. 1997 May-Jun;12(3):325-34. — View Citation

Sorní M, Guarinós J, García O, Peñarrocha M. Implant rehabilitation of the atrophic upper jaw: a review of the literature since 1999. Med Oral Patol Oral Cir Bucal. 2005 Apr 1;10 Suppl 1:E45-56. Review. English, Spanish. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height and width of bone gained	Height and width of bone gained will be measured from CBCT	After 6 monthes
Primary	Bone area percentage	Bone area percentage will be measured by Histo-morphometric analysis	After 6 monthes