GBR With Ptfe With Bovine Bone With and Without Autogenous

Cairo University (CU)

Status and phase: Unknown; Phase 2

Conditions: Atrophied Anterior Maxillary Ridges

Treatments: Other: Geistlich Bio-Oss® bovine bone alone

Study type: Interventional

Funder types: Other

Identifiers

NCT03628157

Bone augmentation

Details and patient eligibility

About

Ridge Augmentation in Atrophic Anterior Maxillary Ridges with a Titanium Reinforced Polytetraflouroethelene Membrane and Anorganic Bovine Bone-Derived Mineral in intervention group and Anorganic Bovine Bone-Derived Mineralwith Particulated Autogenous Bone Chips in control group.

CBCT will be done before surgery, immediate after surgery and 6 month to compare the bone gain in mm.

Bone sample will be collected during exposure after 6 month of surgery by trephine bur to assess the bone quality through histo-morphometric analysis in order to determine the size, shape and orientation of the bony trabeculae, the size and porosity of the bony cortex in addition to the new bone/ bone substitute ratio

• 1ry outcome: Amount of bone gain will be measured using linear measurements from CBCT immediate after surgery and after 6 month.
• 2ry outcome: a bone sample will be collected and analyzed under histo-morphometric analysis.

Enrollment: 10 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• • Patients with atrophied anterior maxillary ridge area.

  • Age: 18 years and older.
  • Both sexes.
  • 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

intervention

Experimental group

Description:

using a bio-oss bovine bone alone

Treatment:

Other: Geistlich Bio-Oss® bovine bone alone

control

Active Comparator group

Description:

using a bio-oss bovine bone with autogenous bone ratio 1:1

Treatment:

Other: Geistlich Bio-Oss® bovine bone alone