COMPARATIVE ANALYSIS OF INNOVATIVE BONE HEALING TECHNIQUES IN MANDIBLE BONE DEFECTS
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- bone density
Study Overview
Brief Summary
the study intends to observe the outcome of interventions (concentrated growth factor with autograft and xenograft) used to expedite bone healing and adaptation with minimal side effects. Three different modalities are being used to bridge the mandibular fracture defects (>5mm-<5cm). Those modalities include group A- autograft, group B-autograft with concentrated growth factor, and group C- xenograft with concentrated growth factor. the outcomes are measured in terms of acquired bone density (Hounsfield unit) that is obtained at the 4th and 6th month post-operatively via cone-beam computed tomography.
Detailed Description
Study Design:
Randomized clinical trial
Study Population:
The study will be conducted on patients with mandible fracture defects, exclusively of defect sizes ranging from 5mm to 5cm.
Study Settings:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male/female
- •Mandible fracture (symphysis, parasymphysis, and body)
- •Defect gap of bone >5mm and <5cm.
- •Non-union fracture. (Fracture that does not heal after 8 weeks of treatment is known as a non-union)
- •Mal-union (when the fracture segments are not in anatomical alignment and heals in that way forming a bone between displaced segments)
- •Delayed union (Fracture which takes greater than 5 weeks to repair is a delayed union)
Exclusion Criteria
- •Systemic disease involvement such as diabetes mellitus.
- •Bone-related disorders such as osteoarthritis,
- •Undergoing Chemo and or radiotherapy
- •Gunshot trauma with more than 5cm bone defect
- •Fracture with open wounds
Arms & Interventions
Group A
group A- autograft
Intervention: autograft (Procedure)
group B
group B- concentrated growth factor with autograft
Intervention: autograft with addition of concenterated growth factor (Procedure)
Group C
group C- concentrated growth factor with xenograft
Intervention: xenograft with concentrated growth factor (Procedure)
Outcomes
Primary Outcomes
bone density
Time Frame: 6 months
acquired bone density in region of interest via cone beam computed tomography expressed in Hounsfield units
Secondary Outcomes
No secondary outcomes reported
Investigators
Samreen Malik
Doctor (MDS trainee)
Dow University of Health Sciences