Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla

NCT03840681 | Unknown DMC

• 1 other identifier: MMetwally
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Guided Bone Regeneration

Outcome Measures

Primary Outcomes (2)

• Height and width of bone gained

  Height and width of bone gained will be measured from CBCT

  After 6 monthes

• Bone area percentage

  Bone area percentage will be measured by Histo-morphometric analysis

  After 6 monthes

Study Arms (2)

Ridge augmentation by collagen membrane

EXPERIMENTAL

* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * Flap will be done. * bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed at defected area then covered at the defected area by a collagen membrane which will be stabilized by tacks. * The site will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures.

Other: Augmentation

augmentation by titanium reinforced PTFE

ACTIVE COMPARATOR

* Intra operative procedures (for both groups) followed by CBCT will be taken for every patient. * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * Flap will be done. * bone decortication will be done using surgical round bur, anorganic bovine bone derived mineral will be packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks. * The site will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures.

Other: Augmentation

Interventions

Augmentation OTHER

non invasive technique to increase bone width and eliminate need for second surgery

Ridge augmentation by collagen membrane; augmentation by titanium reinforced PTFE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (14)

• 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.

  PMID: 26511187 BACKGROUND

• 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.

  PMID: 17066630 BACKGROUND

• Sorni M, Guarinos J, Garcia O, Penarrocha 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. English, Spanish.

  PMID: 15800467 BACKGROUND

• Hoexter DL. Bone regeneration graft materials. J Oral Implantol. 2002;28(6):290-4. doi: 10.1563/1548-1336(2002)0282.3.CO;2.

  PMID: 12498538 BACKGROUND

• 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. doi: 10.1111/j.1600-0501.2006.01357.x.

  PMID: 16968389 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 9197097 BACKGROUND

• Gotfredsen K, Nimb L, Buser D, Hjorting-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. doi: 10.1016/s0278-2391(10)80108-9.

  PMID: 8336225 BACKGROUND

• Kohal RJ, Trejo PM, Wirsching C, Hurzeler 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. doi: 10.1034/j.1600-0501.1999.100306.x.

  PMID: 10522183 BACKGROUND

• 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.

  PMID: 8150510 BACKGROUND

• 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. doi: 10.1902/jop.1994.65.9.881.

  PMID: 7990026 BACKGROUND

• 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.

  PMID: 28833567 BACKGROUND

• McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.

  PMID: 17335361 BACKGROUND

• Hutmacher D, Hurzeler 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.

  PMID: 8908867 BACKGROUND

Study Officials

• Mohamed m Atef

  Cairo U

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohab f Metwally

CONTACT

00201115709990; hobaz90_2000@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Each patient will be given a code by the researcher ( T.A ) and the observer will be blind to which group this case belongs Patients,evaluators and statistican will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: March 1, 2019
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02