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

THE EFFICACY OF RESORBABLE PLATES VERSUS TITANIUM PLATES IN TERMS OF STABILITY AMONG PATIENTS WITH MANDIBULAR FRACTURES: A RANDOMIZED CONTROLLED TRIAL.

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Recruiting
      • Dow University of Health Sciences
      • Contact: Dr.Shaheen Ahmed, FCPS; Phone Number: +923212275892; Email: drshaheenahm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: resorbable plates, test group; 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	Procedure: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates; under general anesthesia , fracture site of the mandible will be exposed and fracture will be reduced anatomically and held together by either resorbable or titanium plates and then the incsion site will be closed with vicryl sutures and patient will be observed on the follow ups clinically and radiographically for the fracture reduction and stability of the fractures with resorbable plates as compared to the titanium plates.
Experimental: titatnium plates, control group; 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	Procedure: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates; under general anesthesia , fracture site of the mandible will be exposed and fracture will be reduced anatomically and held together by either resorbable or titanium plates and then the incsion site will be closed with vicryl sutures and patient will be observed on the follow ups clinically and radiographically for the fracture reduction and stability of the fractures with resorbable plates as compared to the titanium plates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone union	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.	3 months

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Anticipated): November 9, 2022
• Study Completion (Anticipated): November 9, 2022

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Resorbable plates,titanium plates,stability
• Additional Relevant MeSH Terms: Nervous System Diseases; Fractures, Bone; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Jaw Fractures; Maxillofacial Injuries; Facial Injuries; Skull Fractures; Mandibular Fractures
• Other Study ID Numbers: DUHS/BASR/2019/-515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No