Health Condition 1: M264- Malocclusion, unspecified
Conditions
Interventions
Intervention1: Miniplates: 2.0 mm sub-apical miniplate with 4 holes
2.0mm lower border miniplate with 6 holes
Duration: 6 months
Control Intervention1: HBS 2 midi long thread osteosynthesis: 2 screws will be used: Screws used will be of defined dimension: 30mm overal
with proximal thread length of 5mm and diameter of 3.9mm
and distal thread length of 11 mm and diameter of 3.0 mm
Duration: 6 months
Control Intervention2: HBS 2 mini long thread osteosynthesis: 2 screws will be used: Screws used will be of defined dimensi
with proximal thread length of 5mm and diameter of 3.2 mm
and distal thread length of 11 mm and diameter of 2.5 mm
Duration: 6 months
Sponsors
Dr Adity Bansal
Dr Ashi Chug
Eligibility
Inclusion criteria
Inclusion criteria: Patients presenting with anterior mandibular fractures (symphysis or parasymphysis fracture mandible) Patients with anterior mandibular fractures (symphysis or parasymphysis fracture mandible), associated with additional maxillary or other associated facial fractures will also be included, unless anterior mandible requires reconstruction plate fixation Age >18 and less than 50 years Patients presenting within one week of fracture incident
Exclusion criteria
Exclusion criteria: Patients with age of 18 years or less; or more than 50 years Communited anterior mandibular fractures requiring obvious management with reconstruction plating Patients with active infection (pus) at the site of fracture Patients with bone loss at the site of fracture Mal-united fractures or fractures presenting more than 1 week late Edentulous patients requiring reconstruction plate Patient with medical co-morbidities like neurological disorders or low GCS (Glasgow Coma Scale); spine/cervical injuries; uncontrolled diabetes; uncontrolled hypertension, cardio-vascular disorders, bleeding disorders: which contra-indicate surgical management. Patient with known cancer or undergoing/having history of radio-therapy/chemo-therapy. Patient who are active smokers/alcoholic Pregnant patient Patients lost to follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to compare stability of the osteosynthesis by evaluating inter-fragmentary mobility, which will be done by bimanual palpationTimepoint: 3 weeks, 6 weeks, 3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Hardware fractureTimepoint: 3 weeks, 6 weeks, 3 months, 6 months;Hardware looseningTimepoint: 3 weeks, 6 weeks, 3 months, 6 months;Pain score (Visual analogue scale: VAS score)Timepoint: 3 weeks, 6 weeks, 3 months, 6 months;Post-operative infection (edema or pus at the post-operative site)Timepoint: 3 weeks, 6 weeks, 3 months, 6 months;Post-operative nerve paraesthesia (using two-point discrimination)Timepoint: 3 weeks, 6 weeks, 3 months, 6 months;Post-operative occlusionTimepoint: 3 weeks, 6 weeks, 3 months, 6 months;Time taken for the procedureTimepoint: after exposure of fracture site till completion of osteosynthesis i.e intra-operatively | — |
Countries
India
Contacts
Public ContactAdity Bansal
All India Institute of Medical Sciences (AIIMS), Rishikesh
Outcome results
None listed