Clinical Trial to Comparison of Fracture Healing between Closed Reduction Surgery Alone and in Combination with Pulsed Magnetic Filed in Patients with Mandibular Fracture

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016022526769N1

Enrollment

Registered

2016-12-17

Start date

2012-03-20

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandible fx. Lower jaw (bone)

Interventions

Intervention 1: Intervention group: In this group, fracture sites expose to pulsed electromagnetic fields (PEMF) for 6 hours immediately after surgery. Then, this procedure will repeat on the 7th day

Treatment - Surgery

Intervention group: In this group, fracture sites expose to pulsed electromagnetic fields (PEMF) for 6 hours immediately after surgery. Then, this procedure will repeat on the 7th day for 3 hours and

Control group: Only treatment of Mandibular fracture with closed reduction method. The MMF will be removed at sixth weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria included the consent of participating in study, mandible fracture in dental region, existence of enough dental contacts in both sides of fracture line that possibility of application of arch bar and maxillary mandibular fixation (MMF) establishment exists, absence of signs of infection in fracture region, lack of systemic diseases affecting favorable stages of bone regeneration, treatment indications of closed reduction. Exclusion criteria included lack of consent of participating in study and contraindications of closed reduction treatment

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Changes in bone mineral density. Timepoint: Befor Operation, 2 weeks & 4 weeks later. Method of measurement: Radio densitometry.;The post-operative pain. Timepoint: Operation Day, One day later & one week & two weeks later. Method of measurement: Visual Analog Scale (VAS).;The maximum amount of open mouth. Timepoint: End of treatment. Method of measurement: Caliper Vrnyr.;Sensory changes. Timepoint: Prior to operation, a month later, two months later. Method of measurement: Patient verbal affirmation of abnormal lip sensation.	—

Measure

Time frame

Changes in bone mineral density. Timepoint: Befor Operation, 2 weeks & 4 weeks later. Method of measurement: Radio densitometry.;The post-operative pain. Timepoint: Operation Day, One day later & one week & two weeks later. Method of measurement: Visual Analog Scale (VAS).;The maximum amount of open mouth. Timepoint: End of treatment. Method of measurement: Caliper Vrnyr.;Sensory changes. Timepoint: Prior to operation, a month later, two months later. Method of measurement: Patient verbal affirmation of abnormal lip sensation.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hassan Mohajerani

Dental School, Shahid Beheshti University of Medical Sciences.

Mohajeranih@gmail.com+98 21 2222 8511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026