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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04153851
Other study ID # OMFS 6-3-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2019
Est. completion date December 31, 2021

Study information

Verified date November 2019
Source Cairo University
Contact Abdelmoez Elsharkawy, lecturer
Phone 01223194207
Email moezshark@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study the effect of neurectomy of nasopalatine nerve on the sensation of anterior palate in patients undergoing rehabilitation of anterior maxillary ridge with dental implant


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


Recruitment information / eligibility

Status Recruiting
Enrollment 1
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary two point discrimination test 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
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