Comparison of Resorbable Plates With Titanium PlatesNCT05547763
THE EFFICACY OF RESORBABLE PLATES VERSUS TITANIUM PLATES IN TERMS OF STABILITY IN MANDIBULAR FRACTURES.
A study testing surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates in people with Comparison of Resorbable Plates With Titanium Plates, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparison of Resorbable Plates With Titanium Plates
- What is being tested?
- surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Nov 2019to 9 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Age group-18 years and above
- Symphysis and body fractures.
- Non-infected fracture site
Who cannot join
- • Condylar fracture
- Comminuted fractures
- Patients with systemic bone diseases
- Gunshot wounds
- Pan-facial trauma
- Infected wounds
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dow University of Health Sciences
Karachi, Sindh, 74200
Dr.Shaheen Ahmed, FCPS, +923212275892, drshaheenahm@gmail.com
Dr.Abdul Hafeez Shaikh, FCPS, +923332247325, drabdulhafeezshaikh@hotmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates
- Keywords
- Resorbable plates,titanium plates,stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium platesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| resorbable plates, test group | Experimental | 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 Receives: Procedure: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates |
| titatnium plates, control group | Experimental | 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 Receives: Procedure: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start27 Nov 2019
- Primary completion9 Nov 2022 (estimated)
- Study completion9 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparison of Resorbable Plates With Titanium PlatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547763
- Sponsor's protocol ID
- DUHS/BASR/2019/-515
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFICACY OF RESORBABLE PLATES VERSUS TITANIUM PLATES IN TERMS OF STABILITY AMONG PATIENTS WITH MANDIBULAR FRACTURES: A RANDOMIZED CONTROLLED TRIAL.
- ClinicalTrials.gov ID
- NCT05547763
- Acronym / sponsor ID
- DUHS/BASR/2019/-515
- Keywords
- Resorbable plates,titanium plates,stability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 9 Nov 2022 (estimated)
- Study completion
- 9 Nov 2022 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resorbable plates, test group | Experimental | Procedure: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium platesafter 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 | Experimental | Procedure: surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium platesafter 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Age group-18 years and above
Key exclusion criteria (6 listed)
- • Condylar fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium platesunder 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. | Procedure or surgery | resorbable plates, test group, titatnium plates, control group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgically mandible will be exposed to reduced the fracture anatomically and then fixated with either resorbable or the titanium plates in people with Comparison of Resorbable Plates With Titanium Plates, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone union (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.