- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04153851
Study the Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate
Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate in Patient Undergoing Rehabilitation of Atrophic Anterior Maxillary Ridge With Dental Implant
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Replacement of missing teeth in the anterior maxilla could be challenging if enlargement of the nasopalatine canal which is located in the midline of the palate posterior to the maxillary central incisors or ridge atrophy occur after tooth extraction. This could place the neurovascular content of the nasopaltine canal in the path of the dental implant which may lead to complications such as nasopalatine canal cyst, sensory dysfunction or implant failure. Technique to overcome this problem have evolved including neurectomy of the nasopalatine canal content and obliteration of canal with bone graft.
Loss of sensation in anterior palate following this procedure could be an annoying complication for patients. In recent studies regaining of sensation following such procedure have been reported, Confirmation of such results is essential to rule out the side effect of loss of sensation in the anterior palatal region
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdelmoez Elsharkawy, lecturer
- Phone Number: 01223194207
- Email: moezshark@gmail.com
Study Contact Backup
- Name: Hassan Abd El-Gany, professor
- Phone Number: 01001545449
- Email: hassan_ao@yahoo.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Cairo University
-
Contact:
- Abdelmoez Elsharkawy, lecturer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Adult patients requiring dental implants placement in the anterior region of maxilla and has insufficient horizontal bone .
- Patients should be free from any systemic conditions that may affect soft tissue healing.
Exclusion Criteria:
• Patients with systematic disease that may complicate healing.
- Uncontrolled diabetic patient.
- Patients with advanced osteoporosis.
- Patients under bisphosphonates treatment.
- Patients with neurological disorders (neuralgias, Parkinson's disease).
- Patients with horizontal ridge atrophy (if the horizontal dimension of the residual ridge <3mm as determined with ridge callipers).
- Heavy smoker patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: neurectomy of nasopalatine nerve
|
Severing of nerurovascular bundle and pushing the nasopalatine canal content nasally and insertion of bone graft in the canal.
Dental implant will be inserted in the central incisor location
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
two point discrimination test
Time Frame: six months
|
This test will be performed using a calliper, the two points of the calliper are opened progressively in 1mm increments and care should be taken that the two points are touching the mucosa in the same time until the patient can discriminate two points of contact at which the distance between the two points is recorded
|
six months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMFS 6-3-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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