THE EFFICACY OF RESORBABLE PLATES VERSUS TITANIUM PLATES IN TERMS OF STABILITY IN MANDIBULAR FRACTURES.

Not Applicable

Recruiting

• Conditions: Comparison of Resorbable Plates With Titanium Plates
• Interventions: Procedure: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates

• Registration Number: NCT05547763
• Lead Sponsor: Dow University of Health Sciences

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

Study Timeline

• Study Start: 2019-11-27
• Status Verified: 2022-09
• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2022-09-16
• Last Update Submitted: 2022-09-16
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21
• Primary Completion: 2022-11-09
• Study Completion: 2022-11-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resorbable plates, test group	surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates	after a surgical procedure under general anesthesia , resorbable plates will be placed on the fracture site of the mandibule in 20 patients out of 40 total sample size and will be compared with the titanium plates in the control group
titatnium plates, control group	surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates	after a surgical procedure under general anesthesia , titanium plates will be placed on the fracturte site in the mandible in 20 patients out of 40 total sample size and will be compared to the test group containing resorbable plates

Primary Outcome Measures

Name	Time	Method
bone union	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.

Trial Locations

Locations (1)

Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan