to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSONCT04824456
Neurosensory Assesment After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT
A study testing bilateral sagittal split osteotomy using separators. in people with to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO, run by Cairo University at 1 site in Egypt.
Trial summary
The bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO
- What is being tested?
- bilateral sagittal split osteotomy using separators.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 1 Aug 2021
- 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
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients not indicated for orthognathic surgery.
- Severe systemic disease.
- Have a medical condition associated with systemic neuropathy (e.g. diabetes)
- Patients whom cannot tolerate follow up intervals. (affect accuracy of study results)
- Are unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Neurosensory Disturbance After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT
The bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. persistent post-operative neurosensory disturbances of the inferior alveolar nerve are still one of the major complications of this operation. The incidence has decreased over the years due to improved techniques and the use of different instruments. However, most recent series still report postoperative persistent hypesthesia of the inferior alveolar nerve in more than 10% of the patients up to 48%.
There are no reports on the influence of other surgical variables on the persisting post-operative hypesthesia. Several methods have been reported for evaluating neurosensory disturbances of the inferior alveolar nerve. One of the simplest methods reported is tactile evaluation based on subjective sensation reported by the patients. Many authors have used this method in their evaluation of post-operative hypesthesia.
- Being tested
- bilateral sagittal split osteotomy using separators.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral sagittal split osteotomy using separators.Procedure or surgery
The final split is completed with a thin osteotomes, splitting the entire ascending ramus from the anterior to the posterior border of the ramus.
| Study group | Role | What they receive |
|---|---|---|
| bilateral sagittal split osteotomy using chisels. | Experimental | The final split is completed with Smith forceps and flag separators Receives: Procedure: bilateral sagittal split osteotomy using separators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurosensory disturbance of the inferior alveolar nerve.
use Von Frey filaments to test sensory function of the lower lip and two point discrimination test (blunt and sharp ) also to assess the sensory function
Measured: 1 year
Secondary outcomes (3)
Incidence of bad split
if bad split in the mandible occur during the operation it will be reported
Measured: 1 year
post operative edema ,
preoperative measure from the tragus to mid of the chin by cm then the measure is repeated to count the amount of edema
Measured: 1 year
post operative pain
by visual analogue scale from 0 to 10 and the patient choose the number
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start1 Dec 2019
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSOStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hisham Mohammed Abdllfattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824456
- Sponsor's protocol ID
- 15460
- Status last verified
- Mar 2021
- First submitted
- 23 Nov 2020
- Last updated
- 1 Apr 2021
- 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Neurosensory Disturbance After Using Separators Vs Chisels in Bilateral Sagittal Split Mandibular Osteotomy. RCT
- ClinicalTrials.gov ID
- NCT04824456
- Acronym / sponsor ID
- 15460
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 1 Apr 2021 (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 bilateral sagittal split Ramus osteotomy (BSSRO) was introduced by Trauner and Obwegeser. Since then, many modifications of this procedure have been reported, leading to a less difficult and more predictable procedure for correcting mandibular anomalies. persistent post-operative neurosensory disturbances of the inferior alveolar nerve are still one of the major complications of this operation. The incidence has decreased over the years due to improved techniques and the use of different instruments. However, most recent series still report postoperative persistent hypesthesia of the inferior alveolar nerve in more than 10% of the patients up to 48%.
There are no reports on the influence of other surgical variables on the persisting post-operative hypesthesia. Several methods have been reported for evaluating neurosensory disturbances of the inferior alveolar nerve. One of the simplest methods reported is tactile evaluation based on subjective sensation reported by the patients. Many authors have used this method in their evaluation of post-operative hypesthesia.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient with skeletal malocclusion, class II or class III that is indicated for bilateral sagittal split osteotomy.
| Arm | Type | Receives |
|---|---|---|
| bilateral sagittal split osteotomy using chisels. | Experimental | Procedure: bilateral sagittal split osteotomy using separators.The final split is completed with Smith forceps and flag separators |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Patients not indicated for orthognathic surgery.
- Severe systemic disease.
- Have a medical condition associated with systemic neuropathy (e.g. diabetes)
- Patients whom cannot tolerate follow up intervals. (affect accuracy of study results)
- Are unwilling to sign informed consent.
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 |
|---|---|---|
| bilateral sagittal split osteotomy using separators.The final split is completed with a thin osteotomes, splitting the entire ascending ramus from the anterior to the posterior border of the ramus. | Procedure or surgery | bilateral sagittal split osteotomy using chisels. |
Primary outcome
neurosensory disturbance of the inferior alveolar nerve.
Time frame: 1 year
use Von Frey filaments to test sensory function of the lower lip and two point discrimination test (blunt and sharp ) also to assess the sensory function
3 secondary outcomes
Incidence of bad split
Time frame: 1 year
post operative edema ,
Time frame: 1 year
post operative pain
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- 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.
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 bilateral sagittal split osteotomy using separators. in people with to Assess Neurosensory Function of Inferior Alveolar Nerve After BSSO, run by Cairo 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 0 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 1 Apr 2021. 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?
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?
neurosensory disturbance of the inferior alveolar nerve. (time frame: 1 year). 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 1 Apr 2021.