NCT04153851

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

1.1 years

First QC Date

November 2, 2019

Last Update Submit

November 6, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

neurectomy of nasopalatine nerve

OTHER

1. Prophylactic preoperative antibiotic will be administered prior to surgery. 2. Oral disinfection will be performed before surgery. 3. Labial infiltration anesthesia and nasopalatine nerve block anasthesia. 4. The nasopalatine foramen will be exposed after reflection of a palatal and buccal flap. 5. Severing of nerurovascular bundle and pushing the nasopalatine canal content nasally and insertion of bone graft in the canal. 6. Dental implant will be inserted in the central incisor location.

Procedure: neurectomy of nasopalatine nerve

Interventions

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

neurectomy of nasopalatine nerve

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Abdelmoez Elsharkawy, lecturer

CONTACT

Hassan Abd El-Gany, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 2, 2019

First Posted

November 6, 2019

Study Start

December 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations