Mandible FractureNCT06895174
Comparison of the Post-operative Efficacy of Arch Bar With Single Plate and Two Plate Fixation in Mandibular Parasymphsis Fracture.
A study testing Titanium miniplates and Arch Bar in people with Mandible Fracture, run by HITEC-Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
This clinical trial is designed to compare post-operative infection, symptoms of paresthesia, inferior border misalignment and operating time of one plate with arch bar against standard two miniplates in mandibular parasymphysis fracture in order to achieve the treatment which is beneficial for the patients. Read more about this study
- Who is it for?
- Ages 17 to 50 years
- Conditions the study is for
- Mandible Fracture
- What is being tested?
- Titanium miniplates and Arch Bar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2024to 30 Jun 2025
- 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 17 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All patients with mandibular unilateral parasymphysis fracture
Who cannot join
- Mandibular defect fractures.
- Grossly comminuted fractures.
- Medically compromised patient.(e.g uncontrolled metabolic disease
- immunocompromised patient, patient receiving radiation and chemotherapy).
- Multiple fracture of Mandible.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dental College Hitec Institute Of Medical Sciences Taxila Cantt
Taxila, Punjab Province, 47070
About this study
Official title: Efficacy Of Mandibular Parasymphysis Fracture Treatment With Two Miniplates Versus One Miniplate With Arch Bar
This clinical trial is designed to compare post-operative infection, symptoms of paresthesia, inferior border misalignment and operating time of one plate with arch bar against standard two miniplates in mandibular parasymphysis fracture in order to achieve the treatment which is beneficial for the patients. This study will contribute to literature for the betterment of patient.
The objective of this study is to compare the post-operative efficacy of arch bar with single plate and two plate fixation in mandibular parasymphsis fracture.
- Conditions
- Mandible Fracture
- Being tested
- Titanium miniplates, Arch Bar
- Medical subject headings
- Mandibular Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium miniplatesDevice
Titanium miniplates are used for open reduction and internal fixation in mandible fractures according to Champy's principle of osteosynthesis
Arch BarOther
Arch bars are used for intermaxillary fixation in facial fractures as a mean of closed reduction.In this study arch bars placed in tension zone will be combined with single miniplate placed at inferior border of mandible and this modality efficacy will be compared with two miniplate group.
| Study group | Role | What they receive |
|---|---|---|
| Titanium miniplates | Active comparator | Titanium miniplates are used in open reduction and internal fixation for facial fractures including mandible fractures.One miniplate is placed on superior border and other is placed at inferior border for mandible parasymphysis fracture. Receives: Device: Titanium miniplates |
| Arch bars | Other | One Arch bar placed in tension zone for closed reduction technique in mandible fractures is combined with single miniplate placed at the lower border and its efficacy will be compared with two miniplates group Receives: Other: Arch Bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osseous alignment
It is checked after the surgical procedure by evaluating the continuity of lower border of mandible on orthopentomogram on first post-operative day, after 15 days and after 1 month
Measured: Final Alignment will be checked after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Jul 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible FractureStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- HITEC-Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Khattak, HITEC-Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895174
- Sponsor's protocol ID
- fatimakhattak12@gmail.com
- Status last verified
- Jul 2024
- First submitted
- 24 Mar 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: it is not required for this study
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Mandibular Parasymphysis Fracture Treatment With Two Miniplates Versus One Miniplate With Arch Bar
- ClinicalTrials.gov ID
- NCT06895174
- Acronym / sponsor ID
- fatimakhattak12@gmail.com
- Conditions
- Mandible Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- HITEC-Institute of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 26 Mar 2025 (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.
This clinical trial is designed to compare post-operative infection, symptoms of paresthesia, inferior border misalignment and operating time of one plate with arch bar against standard two miniplates in mandibular parasymphysis fracture in order to achieve the treatment which is beneficial for the patients. This study will contribute to literature for the betterment of patient.
The objective of this study is to compare the post-operative efficacy of arch bar with single plate and two plate fixation in mandibular parasymphsis fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium miniplates | Active comparator | Device: Titanium miniplatesTitanium miniplates are used in open reduction and internal fixation for facial fractures including mandible fractures.One miniplate is placed on superior border and other is placed at inferior border for mandible parasymphysis fracture. |
| Arch bars | Other | Other: Arch BarOne Arch bar placed in tension zone for closed reduction technique in mandible fractures is combined with single miniplate placed at the lower border and its efficacy will be compared with two miniplates group |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients with mandibular unilateral parasymphysis fracture
Key exclusion criteria (5 listed)
- Mandibular defect fractures.
- Grossly comminuted fractures.
- Medically compromised patient.(e.g uncontrolled metabolic disease
- Multiple fracture of Mandible.
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 |
|---|---|---|
| Titanium miniplatesTitanium miniplates are used for open reduction and internal fixation in mandible fractures according to Champy's principle of osteosynthesis | Device | Titanium miniplates |
| Arch BarArch bars are used for intermaxillary fixation in facial fractures as a mean of closed reduction.In this study arch bars placed in tension zone will be combined with single miniplate placed at inferior border of mandible and this modality efficacy will be compared with two miniplate group. | Other | Arch bars |
Primary outcome
Osseous alignment
Time frame: Final Alignment will be checked after one month
It is checked after the surgical procedure by evaluating the continuity of lower border of mandible on orthopentomogram on first post-operative day, after 15 days and after 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Undecided. it is not required for this study
Related trials for Mandible Fracture
Recruiting
Optimized Osteosynthesis: Bone Mineral Density Recovery in Mandibular Body Fractures Using Patient-Specific Versus Conventional Plates
Mandibular Fractures
Not yet recruiting
Clinical And Radiographic Assessment of H-shaped Bone Plates in Management of Body and Angle Mandibular Fractures
Mandibular Angle Fractures, Mandibular Body Fractures
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Recruiting
Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series
Pediatric Mandibular Fracture
Recruiting
Custom-Made Titanium Plates Versus Custom-Made Polyether Ether Ketone (PEEK) Plates
Mandibular Fractures
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titanium miniplates and Arch Bar in people with Mandible Fracture, run by HITEC-Institute of Medical 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 8 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osseous alignment (time frame: Final Alignment will be checked after one month). 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 8 Oct 2025.