Anterior Mandibular FractureNCT06938438
Single Locking Miniplates Versus Double Non-Locking Miniplates in Anterior Mandibular Fracture
A study testing single locking miniplate and double conventional miniplates. in people with Anterior Mandibular Fracture, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare clinically and radiographically the using of single locking miniplate versus double non-locking miniplates in internal fixation of anterior mandibular fracture Read more about this study
- Who is it for?
- Ages 17 to 40 years
- Conditions the study is for
- Anterior Mandibular Fracture
- What is being tested?
- single locking miniplate and double conventional miniplates.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 20 Sep 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with displaced symphyseal/ parasymphyseal mandibular fracture
- age group between 17-40 years old
Who cannot join
- Patients with systemic diseases that may affect bone healing
- Comminuted mandibular fracture.
- Edentulous patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Single Locking Miniplates Versus Double Non-Locking Miniplates in Fixation of Anterior Mandibular Fracture
The aim of this study is to compare clinically and radiographically the using of single locking miniplate versus double non-locking miniplates in internal fixation of anterior mandibular fracture
Read the detailed description
This study will be carried out on twenty adult patients with mandibular symphyeal and parasymphyseal fracture indicated for open reduction and internal fixation. The patients will be recieved, clinically\& radiographically examined and managed at Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Patients will be randomly divided into two equal groups according to the type of plating system used in fracture fixation: • Group I: Comprised of ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate. • Group II: Comprised of ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates.
Preoperative evaluation:
A thorough clinical examination will be performed for all patients.An intraoral clinical examination will be done to evaluate occlusal status, hematoma, soft tissue laceration, infection and neural disorder. Preoperative radiographic evaluation will be performed including standardized orthopantomograms (OPG) and CT radiographs to document the presence of the fracture and to determine the degree of displacement
Surgical Technique:
The patients will be operated under inhalational type of general anaesthesia via nasoendotracheal intubation. Disinfection of the surgical field with Betadine and surgical draping, Erich's arch bars will be applied. Mentalis muscle will be exposed and incised perpendicular and deep to the bone, leaving a flap of muscle attached to bone for closure. The mucoperiosteal flap will be raised.
In group I:
Adequate exposure of the fractured segments and adequate reduction of segments by manual reduction which assured by accurate occlusion and disappearance of step between segments. Once occlusion is achieved through intermaxillary fixation, five hole straight single locking titanium miniplate
In group II:
According to Champy principle two miniplates will be placed on the inferior border of the mandible and subapically will be used to fix fracture respectively.
Postoperative evaluation:
All patients of both groups will be evaluated clinically immediately, one week, two weeks, three weeks, four weeks, six weeks, three months and six months post-operatively regarding soft tissue healing, pain, edema, paraesthesia of lower lip, occlusion, stability of the fractured segments and Incidence of hardware failure.
Radiographic evaluation:
All patients will be evaluated using panoramic x-ray immediately and six months post-operatively. Axial, coronal and 3D CT scan will be done immediately and six months post-operatively. Immediate post-operative panoramic x-ray \& CT scan will be done to display the fracture reduction and and the position of plate at the inferior border. Evaluation of bone healing at the fracture site and hardware failure and intergonial distance
- Conditions
- Anterior Mandibular Fracture
- Being tested
- single locking miniplate, double conventional miniplates.
- Keywords
- anterior mandibular fracture, locking miniplate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single locking miniplateProcedure or surgery
Ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate
double conventional miniplates.Procedure or surgery
Ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates.
| Study group | Role | What they receive |
|---|---|---|
| Group I: single locking miniplate | Active comparator | Comprised of ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate Receives: Procedure: single locking miniplate |
| Group II: double conventional miniplates | Active comparator | Comprised of ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates. Receives: Procedure: double conventional miniplates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue healing
either normal healing or dehiscence.
Measured: 1 month
visual analogue scale
0 representing no pain at all and 10 representing severe pain
Measured: 1 month
Edema
utilizing a horizontal and vertical guide with a tape on four reference points:tragus of the ear, soft tissue pogonion, pupil and the intersection between lines drawn from pupil centre falling vertically to inferior border of mandible and line parallel to inferior border of the mandible respectively then obtain the percentage of facial swelling, the difference between measurements of the postoperative and preoperative periods was divided by the value of the preoperative period.
Measured: 1 month
Paraesthesia of lower lip
Two point discrimination test:
Score 0: patients could not tell which tip was felt, even if these were morethan 20 mm apart.
Score 1: patients could distinguish between tips only when the caliper wascalibrated at between 14 and 20 mm.
Score 2: normal sensitivity, patients could discriminate between the tips at ashorter distance than 14 mm.
Measured: 6 months
Occlusion
Uglesic's questionnaire 1. Evaluation of the occlusion after fracture treatment
- 5 points: occlusion altered bilaterally.
- 3 points: occlusion altered on one side . 1 point: occlusion altered on one side. occlusal adjustment required. 3points: occlusion adequate on both sides but not the same as before injury. 5 points: good occlusion obtained 2. Self-evaluation of chewing after treatment
- 5 points: not able to chew 0 points: on soft diet 3 points: on normal diet, but can chew only on one side 5 points: on normal diet
Measured: 6 months
Stability of the fractured segments
stable/unstable based on clinical evaluation by digital palpation, applying pressure across fractured segments
Measured: 6 months
bone healing at the fracture site
The fracture line could or could not be identified on radiograph
Measured: 6 months
hardware failure
either plate fracture or screw loosening
Measured: 6 months
Intergonial distance
Linear measurement by C.T software
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start15 Mar 2022
- Primary completion1 Dec 2024
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Mandibular 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Nashaat Breshah, Tanta University
- Investigators
- Nesreen M Ramadan, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMohamed M Shoushan, Prof, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMohamed E Kamal, Ass Prof, Principal investigator, Faculty of Dentistry, Tanta University, EgyptMaram N Breshah, Lecturer, Principal investigator, Faculty of Dentistry, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938438
- Sponsor's protocol ID
- #R-OS-2-22-12
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Locking Miniplates Versus Double Non-Locking Miniplates in Fixation of Anterior Mandibular Fracture
- ClinicalTrials.gov ID
- NCT06938438
- Acronym / sponsor ID
- #R-OS-2-22-12
- Conditions
- Anterior Mandibular Fracture
- Keywords
- anterior mandibular fracture, locking miniplate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 22 Apr 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.
The aim of this study is to compare clinically and radiographically the using of single locking miniplate versus double non-locking miniplates in internal fixation of anterior mandibular fracture
Detailed description
This study will be carried out on twenty adult patients with mandibular symphyeal and parasymphyseal fracture indicated for open reduction and internal fixation. The patients will be recieved, clinically\& radiographically examined and managed at Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Tanta University. Patients will be randomly divided into two equal groups according to the type of plating system used in fracture fixation: • Group I: Comprised of ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate. • Group II: Comprised of ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates.
Preoperative evaluation:
A thorough clinical examination will be performed for all patients.An intraoral clinical examination will be done to evaluate occlusal status, hematoma, soft tissue laceration, infection and neural disorder. Preoperative radiographic evaluation will be performed including standardized orthopantomograms (OPG) and CT radiographs to document the presence of the fracture and to determine the degree of displacement
Surgical Technique:
The patients will be operated under inhalational type of general anaesthesia via nasoendotracheal intubation. Disinfection of the surgical field with Betadine and surgical draping, Erich's arch bars will be applied. Mentalis muscle will be exposed and incised perpendicular and deep to the bone, leaving a flap of muscle attached to bone for closure. The mucoperiosteal flap will be raised.
In group I:
Adequate exposure of the fractured segments and adequate reduction of segments by manual reduction which assured by accurate occlusion and disappearance of step between segments. Once occlusion is achieved through intermaxillary fixation, five hole straight single locking titanium miniplate
In group II:
According to Champy principle two miniplates will be placed on the inferior border of the mandible and subapically will be used to fix fracture respectively.
Postoperative evaluation:
All patients of both groups will be evaluated clinically immediately, one week, two weeks, three weeks, four weeks, six weeks, three months and six months post-operatively regarding soft tissue healing, pain, edema, paraesthesia of lower lip, occlusion, stability of the fractured segments and Incidence of hardware failure.
Radiographic evaluation:
All patients will be evaluated using panoramic x-ray immediately and six months post-operatively. Axial, coronal and 3D CT scan will be done immediately and six months post-operatively. Immediate post-operative panoramic x-ray \& CT scan will be done to display the fracture reduction and and the position of plate at the inferior border. Evaluation of bone healing at the fracture site and hardware failure and intergonial distance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: single locking miniplate | Active comparator | Procedure: single locking miniplateComprised of ten patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate |
| Group II: double conventional miniplates | Active comparator | Procedure: double conventional miniplates.Comprised of ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates. |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with displaced symphyseal/ parasymphyseal mandibular fracture
- age group between 17-40 years old
Key exclusion criteria (3 listed)
- Patients with systemic diseases that may affect bone healing
- Comminuted mandibular fracture.
- Edentulous patients
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 |
|---|---|---|
| single locking miniplateTen patients in whom anterior mandibular fractures will be fixed with titanium single locking miniplate | Procedure or surgery | Group I: single locking miniplate |
| double conventional miniplates.Ten patients in whom, anterior mandibular fractures will be fixed with double conventional titanium miniplates. | Procedure or surgery | Group II: double conventional miniplates |
Primary outcome
Soft tissue healing
Time frame: 1 month
either normal healing or dehiscence.
visual analogue scale
Time frame: 1 month
0 representing no pain at all and 10 representing severe pain
Edema
Time frame: 1 month
utilizing a horizontal and vertical guide with a tape on four reference points:tragus of the ear, soft tissue pogonion, pupil and the intersection between lines drawn from pupil centre falling vertically to inferior border of mandible and line parallel to inferior border of the mandible respectively then obtain the percentage of facial swelling, the difference between measurements of the postoperative and preoperative periods was divided by the value of the preoperative period.
Paraesthesia of lower lip
Time frame: 6 months
Two point discrimination test: Score 0: patients could not tell which tip was felt, even if these were morethan 20 mm apart. Score 1: patients could distinguish between tips only when the caliper wascalibrated at between 14 and 20 mm. Score 2: normal sensitivity, patients could discriminate between the tips at ashorter distance than 14 mm.
Occlusion
Time frame: 6 months
Uglesic's questionnaire 1. Evaluation of the occlusion after fracture treatment * 5 points: occlusion altered bilaterally. * 3 points: occlusion altered on one side . 1 point: occlusion altered on one side. occlusal adjustment required. 3points: occlusion adequate on both sides but not the same as before injury. 5 points: good occlusion obtained 2. Self-evaluation of chewing after treatment * 5 points: not able to chew 0 points: on soft diet 3 points: on normal diet, but can chew only on one side 5 points: on normal diet
Stability of the fractured segments
Time frame: 6 months
stable/unstable based on clinical evaluation by digital palpation, applying pressure across fractured segments
bone healing at the fracture site
Time frame: 6 months
The fracture line could or could not be identified on radiograph
hardware failure
Time frame: 6 months
either plate fracture or screw loosening
Intergonial distance
Time frame: 6 months
Linear measurement by C.T software
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 3 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Anterior Mandibular Fracture
Not yet recruiting
Evaluation of Condylar Position After Anterior Mandibular Fracture Fixation Using Plates Versus Headless Compression Screws
Anterior Mandibular Fracture
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Comparing Bone Healing in Jaw Fractures Fixed With Herbert Screws Versus 3D Miniplates
Anterior Mandibular Fracture
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.
Nesreen M Ramadan principal investigator
Faculty of Dentistry, Tanta University, Egypt
Mohamed M Shoushan, Prof principal investigator
Faculty of Dentistry, Tanta University, Egypt
Mohamed E Kamal, Ass Prof principal investigator
Faculty of Dentistry, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single locking miniplate and double conventional miniplates. in people with Anterior Mandibular Fracture, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 3 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 3 Feb 2026. 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 Egypt. 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?
Soft tissue healing (time frame: 1 month). The study lists 9 primary outcomes in all. 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 3 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.