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Assessment of the Effect of Oral Vitamin C Supplementation on Early Phase Healing of Mandibular Fractures with Ultrasonography

Assessment of the Effect of Oral Vitamin C Supplementation on Early Phase Healing of Mandibular Fractures with Ultrasonography

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202501506241008
Enrollment
50
Registered
2025-01-29
Start date
2024-06-23
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Injury, Occupational Diseases, Poisoning

Interventions

Sponsors

Dr. Amina Mohammed Jaji
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All consenting patients aged 14-60 with clinical and radiological evidence of mandibular fracture who meet the criteria for closed reduction and immobilisation during the study period will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Pregnant or nursing mothers; because of the stress of pregnancy and breastfeeding may not be a good candidate for the study even though they met the inclusion criteria. 2. Edentulous patients 3. A known history of renal insufficiency because of vitamin C metabolism. 4. Comminuted fractures 5. Condylar fractures 6. Subjects with diabetes mellitus because they are on controlled diet which may impact their nutrition and inadvertently their rate of healing, the condition may also affect their healing ability based on whether the condition is controlled, which is beyond the control of the researcher. 7. Subjects with coexisting jaw lesions either benign or malignant lesions 8. Patients with pathologic mandibular fracture 9. History of allergy to Vitamin C

Design outcomes

Primary

MeasureTime frame
Fracture healing will be evaluated using an ultrasound scanner; CS-50 Ultrasound Scanner: Nortek Healthcare City (Shenzhen China 2015) with 3.5MHz curvilinear transducer. The scan will be performed at the following periods: immediately following MMF, 21 days (3 weeks), and 42 days (6 weeks). During the scan, the Ultrasonic probe will be placed at the inferior border of the mandible extra orally, perpendicular to the long axis of the teeth in the fracture site, fractured bone surfaces and the contiguous healthy bone will be imaged. All sonographic examinations and interpretations will be performed by a consultant radiologist experienced in musculoskeletal ultrasound. The researcher will bear the cost of all the ultrasound scans. Qualitative and quantitative assessment of callous formed will be done. Qualitative assessment is based on the echogenicity of the callous formed and it is classified as isoechoic, hypoechoic and hyperechoic which represents complete, partial or absence of a hyperechoic bridge respectively. Quantitative assessment will be done by measuring the fracture gap from edge to edge of the adjacent healthy bones in millimetres using an ultrasonographic calliper. The ratio of the hyperechoic bridge formed to the fractured gap represents the thickness of the callus formed, while the ratio of the hyperechoic bridge to the time in days is the rate of formation of the callus.

Secondary

MeasureTime frame
Rate of healing of mandibular body fractures with Vitamin C supplementation in the test and control group, using ultrasonography.

Countries

Nigeria

Contacts

Public ContactAmina Mohammed Jaji

Senior Resident Doctor Department of Oral and Maxillofacial Surgery

aminamohammedjaji@gmail.com+2348100300107

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026