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Status unknownNCT03840681Updated Feb 15, 2019

Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla

An interventional study of Augmentation in Guided Bone Regeneration, sponsored by Cairo University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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

Read the detailed 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.
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Conditions studied

  • Guided Bone Regeneration

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03

In context

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's planned enrollment of 20 is below the median of 34 across 603 interventional studies indexed under Atrophy.

Browse Atrophy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Ridge augmentation by collagen membrane

    * 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

  • Active comparator
    augmentation by titanium reinforced PTFE

    * 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

  • OtherAugmentation

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

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What researchers measure

Primary outcomes

  1. Height and width of bone gained

    Height and width of bone gained will be measured from CBCT

    Time frame: After 6 monthes

  2. Bone area percentage

    Bone area percentage will be measured by Histo-morphometric analysis

    Time frame: After 6 monthes

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 26511187 ↗
  • 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. PubMed 17066630 ↗
  • 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. PubMed 15800467 ↗
  • Hoexter DL. Bone regeneration graft materials. J Oral Implantol. 2002;28(6):290-4. doi: 10.1563/1548-1336(2002)0282.3.CO;2. PubMed 12498538 ↗
  • 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. PubMed 16968389 ↗
  • 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.
  • 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. PubMed 9197097 ↗
  • 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. PubMed 8336225 ↗
  • 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. PubMed 10522183 ↗
  • 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. PubMed 8150510 ↗
  • 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. PubMed 7990026 ↗
  • 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. PubMed 28833567 ↗
  • McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048. PubMed 17335361 ↗
  • 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. PubMed 8908867 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03840681
Lead sponsor
Cairo University
Responsible party
Mohab Fathy Metwally (Master student, Cairo University) — Principal investigator
First posted
Feb 15, 2019
Start date
Mar 2019 (estimated)
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Feb 15, 2019

Study contacts

Mohab f Metwally
Contact
hobaz90_2000@hotmail.com
00201115709990
Mohamed m Atef
principal investigator · Cairo U

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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