Maxillofacial TraumaNCT06221527
Assessment of Healing Properties Using Hyaluronic Acid Topical Application in Parasymphyseal Fracture Fixation: A Randomized Clinical Trial
A study testing conventional group in people with Maxillofacial Trauma, run by Cairo University.
Trial summary
HA is favorable for osteogenesis, enhancing bone growth, acting a vector for osteoinductive compounds and promoting even distribution and increased density of newly formed bone, thereby altering the scaffold morphology and improving mineralization. Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Trauma
- What is being tested?
- conventional group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with unilateral Para symphyseal fracture
- Systemically healthy patients (American Society of Anesthesiologists -ASA I and II)
- Age of the patient above 16 years to 60 years old
- Patient of both sexes
- Patients willing for the surgical procedure and follow up with an informed consent.
Who cannot join
- Bad oral hygiene
- smokers (>10cigarettes/day)
- Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
- Radiotherapy or chemotherapy form malignancy
- Patients who refused to sign consent form
About this study
HA is favorable for osteogenesis, enhancing bone growth, acting a vector for osteoinductive compounds and promoting even distribution and increased density of newly formed bone, thereby altering the scaffold morphology and improving mineralization. In this study 22 volunteers will be included in this study, the volunteers will be randomly distributed into two groups each containing 11 volunteers, one group will be treated by hyaluronic acid before fixation and the other group will be treated by fixation only without placement of hyaluronic acid, to compensate for drop out 13 volunteers per group
Read the detailed description
Patients of both groups will be subjected to:
- Clinical assessment including case history including personal data,medical,surgical history and family history
- Radiographic assessment includes preoperative digital panomora to evaluate fracture and to conclude presence or absence of any foreign body or pathological pathosis.
- Signing the informed consent will be done after explaining surgical procedure. All the patients will be nasally intubated, scrubbed and draped in the standard manner, followed by intra-oral and extra-oral povidone-iodine (Betadine)swabbing.
Local anesthesia containing vasoconstrictor will be injected in the vestibule Incision at lower anteriors will be done in the mucosa in a curvilinear fashion 10-15mm away from the attached gingiva, the incision distal to the canine will be 5 mm from the attached gingival to be superior to the mental nerve.
Submucosal dissection will be done to expose the mentalis muscle, followed by mucoperiosteal flap elevation till inferior border exposing the fracture line.
The fracture segments will be reduced after curettage and removal of any debris.
MMF will be done to ensure proper occlusion. Two four-hole titanium miniplates will be placed on inferior border and another one on superior border.
For the intervention group: placement of hyaluronic acid paste will be carried over gel foam and placed between fractured segments before plate fixation.
For the control group: no hyaluronic acid paste will be applied during fixation only gel foam between fractures segments without any additives.
Suturing using 4-0 resorbable sutures will take place after MMF release in layers, anteriorly mentalis muscle will be closed first to prevent chin drooping followed by a continuous running closure of mucosa.
Elastic dressing will be applied over chin region supporting the soft tissues and preventing hematoma formation.
Post-operative care:
Avoid traumatization of the surgical site. All patients will be instructed to apply ice packs over submental area for 15 minutes per hour for 24 hours postoperatively.
All patients will be given postoperative medication as follows:
Anti-inflammatory drug diclofenac potassium (Cataflam50mg)2tabletsevery8hoursforaweek to relieve pain Antibiotic drug Amoxicillin/clavulanic acid tablets (Hibiotic 1gm)1gm every 12 hours for 7 days
-Benzethonium Chloride (Antiseptol mouthwash), starting from the day after the surgery 3 times daily for 10 days.
Instruct the patient not to touch or manipulate the surgical area. No consumption of tobacco for one week postoperatively.
- Conditions
- Maxillofacial Trauma
- Being tested
- conventional group
- Keywords
- parasymphyseal fracture, hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional groupProcedure or surgery
Also called study group,- Placement of hyaluronic acid paste will be carried over gel foam and placed between fractured segments of parasymphysial before plate fixation
fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Active comparator | fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border. Receives: Procedure: conventional group |
| study group | Active comparator | placement of hyaluronic acid will be carried over gel foam and placed between fractured segments before plate fixation.
fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border. Receives: Procedure: conventional group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction(score)
Patient satisfaction survey through score
Measured: at one week and three months intervals
Secondary outcomes (1)
Fracture gap distance(mm)
Radiographically(CBCT) through millimeter
Measured: immediate postoperative and four months intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial TraumaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- comparison between healing properties using hyaluronic acid topical application and not using it in parasymphyseal fracture
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aisha khaled mansour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221527
- Sponsor's protocol ID
- Omfs 3 3 16
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Healing Properties Using Hyaluronic Acid Topical Application in Parasymphyseal Fracture Fixation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06221527
- Acronym / sponsor ID
- Omfs 3 3 16
- Conditions
- Maxillofacial Trauma
- Keywords
- parasymphyseal fracture, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Jan 2024 (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.
HA is favorable for osteogenesis, enhancing bone growth, acting a vector for osteoinductive compounds and promoting even distribution and increased density of newly formed bone, thereby altering the scaffold morphology and improving mineralization. In this study 22 volunteers will be included in this study, the volunteers will be randomly distributed into two groups each containing 11 volunteers, one group will be treated by hyaluronic acid before fixation and the other group will be treated by fixation only without placement of hyaluronic acid, to compensate for drop out 13 volunteers per group
Detailed description
Patients of both groups will be subjected to:
- Clinical assessment including case history including personal data,medical,surgical history and family history
- Radiographic assessment includes preoperative digital panomora to evaluate fracture and to conclude presence or absence of any foreign body or pathological pathosis.
- Signing the informed consent will be done after explaining surgical procedure. All the patients will be nasally intubated, scrubbed and draped in the standard manner, followed by intra-oral and extra-oral povidone-iodine (Betadine)swabbing.
Local anesthesia containing vasoconstrictor will be injected in the vestibule Incision at lower anteriors will be done in the mucosa in a curvilinear fashion 10-15mm away from the attached gingiva, the incision distal to the canine will be 5 mm from the attached gingival to be superior to the mental nerve.
Submucosal dissection will be done to expose the mentalis muscle, followed by mucoperiosteal flap elevation till inferior border exposing the fracture line.
The fracture segments will be reduced after curettage and removal of any debris.
MMF will be done to ensure proper occlusion. Two four-hole titanium miniplates will be placed on inferior border and another one on superior border.
For the intervention group: placement of hyaluronic acid paste will be carried over gel foam and placed between fractured segments before plate fixation.
For the control group: no hyaluronic acid paste will be applied during fixation only gel foam between fractures segments without any additives.
Suturing using 4-0 resorbable sutures will take place after MMF release in layers, anteriorly mentalis muscle will be closed first to prevent chin drooping followed by a continuous running closure of mucosa.
Elastic dressing will be applied over chin region supporting the soft tissues and preventing hematoma formation.
Post-operative care:
Avoid traumatization of the surgical site. All patients will be instructed to apply ice packs over submental area for 15 minutes per hour for 24 hours postoperatively.
All patients will be given postoperative medication as follows:
Anti-inflammatory drug diclofenac potassium (Cataflam50mg)2tabletsevery8hoursforaweek to relieve pain Antibiotic drug Amoxicillin/clavulanic acid tablets (Hibiotic 1gm)1gm every 12 hours for 7 days
-Benzethonium Chloride (Antiseptol mouthwash), starting from the day after the surgery 3 times daily for 10 days.
Instruct the patient not to touch or manipulate the surgical area. No consumption of tobacco for one week postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison between healing properties using hyaluronic acid topical application and not using it in parasymphyseal fracture
| Arm | Type | Receives |
|---|---|---|
| conventional group | Active comparator | Procedure: conventional groupfixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border. |
| study group | Active comparator | Procedure: conventional groupplacement of hyaluronic acid will be carried over gel foam and placed between fractured segments before plate fixation. fixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with unilateral Para symphyseal fracture
- Systemically healthy patients (American Society of Anesthesiologists -ASA I and II)
- Age of the patient above 16 years to 60 years old
- Patient of both sexes
- Patients willing for the surgical procedure and follow up with an informed consent.
Key exclusion criteria (5 listed)
- Bad oral hygiene
- smokers (>10cigarettes/day)
- Existence of a bone metabolic disease; currently taking drugs that might influence bone metabolism
- Radiotherapy or chemotherapy form malignancy
- Patients who refused to sign consent form
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 |
|---|---|---|
| conventional groupAlso: study group,- Placement of hyaluronic acid paste will be carried over gel foam and placed between fractured segments of parasymphysial before plate fixationfixation of parasymphyseal fracture using two four-hole titanium miniplates that will be placed on inferior border and another one on superior border | Procedure or surgery | conventional group, study group |
Primary outcome
Patient satisfaction(score)
Time frame: at one week and three months intervals
Patient satisfaction survey through score
1 secondary outcome
Fracture gap distance(mm)
Time frame: immediate postoperative and four months intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing conventional group in people with Maxillofacial Trauma, run by Cairo University.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Patient satisfaction(score) (time frame: at one week and three months intervals). 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 24 Jan 2024.