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Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03664219
Recruitment Status : Unknown
Verified September 2018 by ibrahim hassan bashier garoushi, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
ibrahim hassan bashier garoushi, Cairo University

Study Description
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Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Implant Site Reaction Other: isolation of IAN from implant with collagen membrane Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Atrophied posterior mandible
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Neurosensory Disturbances After Inferior Alveolar Nerve Lateralization With and Without Isolation of the Simultaneously Placed Implants Using Collagen Membrane
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664219


Contacts
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Contact: ibrahim H garoushi 00201022478985 ext 0020 garoushi.ibrahim@gmail.com

Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: ibrahim hassan bashier garoushi, Director, Cairo University
ClinicalTrials.gov Identifier: NCT03664219    
Other Study ID Numbers: 14422016472019
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No