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Study the Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate

Primary Purpose

Missing Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
neurectomy of nasopalatine nerve
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Missing Teeth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cairo universityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

neurectomy of nasopalatine nerve

Arm Description

Prophylactic preoperative antibiotic will be administered prior to surgery. Oral disinfection will be performed before surgery. Labial infiltration anesthesia and nasopalatine nerve block anasthesia. The nasopalatine foramen will be exposed after reflection of a palatal and buccal flap. 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 2, 2019
Last Updated
November 6, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04153851
Brief Title
Study the Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate
Official Title
Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate in Patient Undergoing Rehabilitation of Atrophic Anterior Maxillary Ridge With Dental Implant
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
neurectomy of nasopalatine nerve
Arm Type
Other
Arm Description
Prophylactic preoperative antibiotic will be administered prior to surgery. Oral disinfection will be performed before surgery. Labial infiltration anesthesia and nasopalatine nerve block anasthesia. The nasopalatine foramen will be exposed after reflection of a palatal and buccal flap. 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.
Intervention Type
Procedure
Intervention Name(s)
neurectomy of nasopalatine nerve
Intervention Description
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
Primary Outcome Measure Information:
Title
two point discrimination test
Description
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
Time Frame
six months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelmoez Elsharkawy, lecturer
Phone
01223194207
Email
moezshark@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan Abd El-Gany, professor
Phone
01001545449
Email
hassan_ao@yahoo.com
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdelmoez Elsharkawy, lecturer

12. IPD Sharing Statement

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Study the Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate

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