Injury of Mental Nerve of One SideNCT04218474
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
A study testing Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury in people with Injury of Mental Nerve of One Side, run by Ahmed Mohamed Basem at 1 site in Egypt.
Trial summary
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin \&Lip Sensation Post Inferior Alveolar Nerve Injury Read more about this study
- Who is it for?
- Ages 5 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury of Mental Nerve of One Side
- What is being tested?
- Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Oct 2020
- 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 5 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with hemimandiblectomy
- Patients with Injured Inferior Alveolar Nerve which not showing any healing after 9 months
- Age group : from 15 to 60 years old
- No sex predilection
- Patients with no contraindications to surgical intervention
Who cannot join
- • Patients with systemic condition counteracting with the surgical procedure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Oral and Dental Medicine Cairo University
Cairo
ahmed basem, 00201159300386 ext. asdsa, ahmed_basem1234@hotmail.com
About this study
Official title: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Lower Chin &Lip Sensation Post Inferior Alveolar Nerve Injury and Ablative Mandibular Resectons
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin \&Lip Sensation Post Inferior Alveolar Nerve Injury
- Conditions
- Injury of Mental Nerve of One Side
- Being tested
- Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve InjuryProcedure or surgery
-sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one
| Study group | Role | What they receive |
|---|---|---|
| patient lost sensation ant half of lower lip | Other | patient with injured inferior alveolar nerve at one side Receives: Procedure: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
The primary outcome is restoration of sensation of lower lip and chin sensation determined by Two discrimination point test at 6 months . Aggregation will be done by percentage/ratio of successful cases number in the study. Calculation of the mean of all cases will be performed for analysis of the results.
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 posted6 Jan 2020
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injury of Mental Nerve of One SideStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Mohamed Basem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Mohamed Basem, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218474
- Sponsor's protocol ID
- 2569369
- Status last verified
- Jan 2020
- First submitted
- 27 Nov 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kaban LB, Upton J. Cross mental nerve graft for restoration of lip sensation after inferior alveolar nerve damage: report of case. J Oral Maxillofac Surg. 1986 Aug;44(8):649-51. doi: 10.1016/s0278-2391(86)80078-7. No abstract available.
PubMed 3461143
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Cross Mental Nerve Transfer In Restoration Of Lower Chin &Lip Sensation Post Inferior Alveolar Nerve Injury and Ablative Mandibular Resectons
- ClinicalTrials.gov ID
- NCT04218474
- Acronym / sponsor ID
- 2569369
- Conditions
- Injury of Mental Nerve of One Side
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ahmed Mohamed BasemUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 6 Jan 2020 (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.
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin \&Lip Sensation Post Inferior Alveolar Nerve Injury
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient lost sensation ant half of lower lip | Other | Procedure: Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injurypatient with injured inferior alveolar nerve at one side |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with hemimandiblectomy
- Patients with Injured Inferior Alveolar Nerve which not showing any healing after 9 months
- Age group : from 15 to 60 years old
- No sex predilection
- Patients with no contraindications to surgical intervention
Key exclusion criteria (1 listed)
- • Patients with systemic condition counteracting with the surgical procedure.
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 |
|---|---|---|
| Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury-sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one | Procedure or surgery | patient lost sensation ant half of lower lip |
Primary outcome
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury
Time frame: 1 year
The primary outcome is restoration of sensation of lower lip and chin sensation determined by Two discrimination point test at 6 months . Aggregation will be done by percentage/ratio of successful cases number in the study. Calculation of the mean of all cases will be performed for analysis of the results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Results publication: PubMed 3461143Kaban LB, Upton J. Cross mental nerve graft for restoration of lip sensation after inferior alveolar nerve damage: report of case. J Oral Maxillofac Surg. 1986 Aug;44(8):649-51. doi: 10.1016/s0278-2391(86)80078-7. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Injury of Mental Nerve of One Side
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Faculty of Oral and Dental Medicine Cairo University
Cairo, 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 Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury in people with Injury of Mental Nerve of One Side, run by Ahmed Mohamed Basem 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 5 inclusion and 1 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 7 Jan 2020. 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?
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?
Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218474, which also lists 1 linked publication.
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 7 Jan 2020.