THE EFFICACY OF RESORBABLE PLATES VERSUS TITANIUM PLATES IN TERMS OF STABILITY AMONG PATIENTS WITH MANDIBULAR FRACTURES: A RANDOMIZED CONTROLLED TRIAL.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Comparison of Resorbable Plates With Titanium Plates
- Sponsor
- Dow University of Health Sciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- bone union
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Objective To compare the efficacy of resorbable plates against titanium plates to determine the fixation stability in reducing mandibular fractures
Method:
Subjects will be recruited and divided into two groups by random allocation. Consents will be obtained and fracture sites will be examined clinically and radiographically. Control group will receive titanium plates and test group will receive resorbable plates. The patients will be recalled immediately at first postop day then at the end of the first month , second month and the third month.They will be evaluated for the reduction of the fractures.
Detailed Description
Study design: randomized controlled trial Study Setting: The study will be carried out at the Department Of Oral and maxillofacial Surgery in Dow University of Health Sciences and Civil Hospital Karachi Study Population: Samples will be recruited by setting the following criteria: Inclusion Criteria: * Age group-18 years and above * Symphysis and body fractures. * Non-infected fracture site Exclusion Criteria: * Condylar fracture * Comminuted fractures * Patients with systemic bone diseases * Gunshot wounds * Pan-facial trauma * Infected wounds Sample Size: Total 40 patients will be carried out (20 in treatment \& 20 in control group). Using PASS version 11, two sample proportions with 95% confidence interval, 90% power of the test, 100% proportion of union of the fracture in resorbable fixation (treatment group) and 99% in titanium (control group),calculated sample size is 35 in each group keeping the population at approximately 120 patients in six months, calculated sample size is 70 patients.(18) But due to the budget constraints treatment group (resorbable fixation) will contain 20 patients and control group (titanium) will contain 20 patients Sampling Technique: Consecutive Sampling Data Collection Procedure: Data will be collected from the patients after receiving informed consent. Baseline demographic variable will be recorded using a predesigned questionnaire. Patients will be allocated to either resorbable or titanium plate group through random allocation \[through lottery method\]. Assessment will be done clinically and radiographically on CBCT scan (available at Dow International Dental College) First follow up assessment will be done immediately post op. Further assessments will be done at the completion of 2nd month and and then the 3rd month. Statistical Analyses: Data will be entered and analyzed using SPSS v 22. Mean and standard deviation will be calculated for all continuous variables, whereas frequencies and percentages will be calculated for all categorical variables. Efficacy of the intervention group will be assessed using chi-squared test. Study Variables Independent Variables: Interventions: Titanium or Resorbable plates Dependent Variables Fixation stability Co-variates: Age, Gender, Fracture site
Investigators
Eligibility Criteria
Inclusion Criteria
- •• Age group-18 years and above
- •Symphysis and body fractures.
- •Non-infected fracture site
Exclusion Criteria
- •• Condylar fracture
- •Comminuted fractures
- •Patients with systemic bone diseases
- •Gunshot wounds
- •Pan-facial trauma
- •Infected wounds
Outcomes
Primary Outcomes
bone union
Time Frame: 3 months
union of the fractured bone will be observed radiographically at the end of the first ,second and the third month by a cone beam computed tomography.