Assessment of Guided Bone Regeneration in Atrophic Anterior Maxilla Using Native Collagen vs Titanium Reinforced Polytetraflouroethelene Membranes Using an Organic Bovine Bone Mineral
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 20
- Primary Endpoint
- Height and width of bone gained
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
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.
Intervention: Augmentation (Other)
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.
Intervention: Augmentation (Other)
Outcomes
Primary Outcomes
Height and width of bone gained
Time Frame: After 6 monthes
Height and width of bone gained will be measured from CBCT
Bone area percentage
Time Frame: After 6 monthes
Bone area percentage will be measured by Histo-morphometric analysis
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohab Fathy Metwally
Master student
Cairo University