Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla

Not Applicable

• Conditions: Guided Bone Regeneration
• Interventions: Other: Augmentation

• Registration Number: NCT03840681
• Lead Sponsor: Cairo University

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

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15
• Study Start: 2019-03
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridge augmentation by collagen membrane	Augmentation	* 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.
augmentation by titanium reinforced PTFE	Augmentation	* 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.

Primary Outcome Measures

Name	Time	Method
Height and width of bone gained	After 6 monthes	Height and width of bone gained will be measured from CBCT
Bone area percentage	After 6 monthes	Bone area percentage will be measured by Histo-morphometric analysis