Assessment of Healing Properties Using Hyaluronic Acid Topical Application in Parasymphyseal Fracture Fixation: A Randomized Clinical Trial

NCT06221527 | Unknown

• 1 other identifier: Omfs 3 3 16
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

HA is favorable for osteogenesis, enhancing bone growth, acting a vector for osteoinductive compounds and promoting even distribution and increased density of newly formed bone, thereby altering the scaffold morphology and improving mineralization. In this study 22 volunteers will be included in this study, the volunteers will be randomly distributed into two groups each containing 11 volunteers, one group will be treated by hyaluronic acid before fixation and the other group will be treated by fixation only without placement of hyaluronic acid, to compensate for drop out 13 volunteers per group

Conditions

Maxillofacial Trauma

Keywords

parasymphyseal fracture; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction(score)

  Patient satisfaction survey through score

  at one week and three months intervals

Secondary Outcomes (1)

• Fracture gap distance(mm)

  immediate postoperative and four months intervals

Other Outcomes (3)

• BV\TV (Bone Volume Fraction ) (%)

  immediate postoperative and four months intervals

• Pain(VAS)

  at one week and three months intervals

• Wound dehiscence(Binary)

  at one week and three months intervals

Study Arms (2)

conventional group

ACTIVE COMPARATOR

fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border.

Procedure: conventional group

study group

ACTIVE COMPARATOR

placement of hyaluronic acid will be carried over gel foam and placed between fractured segments before plate fixation. fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border.

Procedure: conventional group

Interventions

conventional group PROCEDURE

fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border

Also known as: study group,- Placement of hyaluronic acid paste will be carried over gel foam and placed between fractured segments of parasymphysial before plate fixation

conventional group; study group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with unilateral Para symphyseal fracture
• Systemically healthy patients (American Society of Anesthesiologists -ASA I and II)
• Age of the patient above 16 years to 60 years old
• Patient of both sexes
• Patients willing for the surgical procedure and follow up with an informed consent.

You may not qualify if:

• Bad oral hygiene
• smokers (\>10cigarettes/day)
• Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
• Radiotherapy or chemotherapy form malignancy
• Patients who refused to sign consent form

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double(Participant, Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: comparison between healing properties using hyaluronic acid topical application and not using it in parasymphyseal fracture

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: January 24, 2024

Record last verified: 2024-01