COMPARATIVE ANALYSIS OF INNOVATIVE BONE HEALING TECHNIQUES

NCT05480631 | Unknown Phase 2 DMC

• 1 other identifier: IRB-1835/DUHS/approval/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

To Assess the Bone Healing in Fracture Mandible Defects

Keywords

Concentrated growth factor, bone density, mandible fracture

Outcome Measures

Primary Outcomes (1)

• bone density

  acquired bone density in region of interest via cone beam computed tomography expressed in Hounsfield units

  6 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

group A- autograft

Procedure: autograft

group B

EXPERIMENTAL

group B- concentrated growth factor with autograft

Procedure: autograft with addition of concenterated growth factor

Group C

EXPERIMENTAL

group C- concentrated growth factor with xenograft

Procedure: xenograft with concentrated growth factor

Interventions

autograft PROCEDURE

autologous bone placed in the defect and then be secured with mini-screws to fill the fracture defect gap

Group A

autograft with addition of concenterated growth factor PROCEDURE

the bone particulate harvested from the donor site will then be mixed with concentrated growth factor to bridge the fracture defect.

group B

xenograft with concentrated growth factor PROCEDURE

xenogenic bovine bone particulate mixed with platelet-derived concentrated growth factor to be held in place of fracture defect site.

Group C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of health sciences

Karachi, Sindh, 74200, Pakistan

RECRUITING

MeSH Terms

Conditions

Mandibular Fractures

Interventions

Transplantation, Autologous; Transplantation, Heterologous

Condition Hierarchy (Ancestors)

Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Skull Fractures; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor (MDS trainee)

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: December 17, 2020
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)