Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization

September 7, 2018 updated by: ibrahim hassan bashier garoushi, Cairo University

Evaluation of the Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization With and Without Isolation of the Simultaneously Placed Implants Using Collagen Membrane

Evaluation of the neurosensory disturbances after inferior alveolar nerve lateralization with and without isolation of the simultaneously placed implants using collagen membrane And measuring the stability of implants after placement .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients with with atrophied posterior mandibular ridge
  • Both sexes.
  • No intraoral soft and hard tissue pathology.
  • No systemic condition that contraindicate implant placement.

Exclusion Criteria:

  • Presence pathological lesions
  • Heavy smokers more than 20 cigarettes per day .(24)
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems
  • Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: isolation of IAN nerve with collagen membrane
Other: isolation of IAN from implant with collagen membrane
comparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant
EXPERIMENTAL: without isolation of the IAN with collagen
Other: isolation of IAN from implant with collagen membrane
comparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurosensory disturbances - sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area
Time Frame: Year
Assessing the sensation regaining over time subjective ( a scale 1-10 ) and objective checking the area of sensation regaining
Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability - Osstell device to assess the primary stability of placed dental implant
Time Frame: Year
Osstell device to assess the primary stability of placed dental implant after nerve lateraliztion
Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (ACTUAL)

September 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 14422016472019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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