- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03669510
Assessment of the Neurosensory Alteration After Inferior Alveolar Nerve Lateralization
April 17, 2024 updated by: Mohamed Reda Mohamed Abdelhady
Assessment of the Neurosensory Alteration With Computer Guided Inferior Alveolar Nerve Lateralization Versus Non Guided Classic Technique
: Assessment of the neurosensory alteration with computer guided inferior alveolar nerve lateralization versus non guided classic technique and measuring stability of implant after placement
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
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.
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Dentistry, Cairo University
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adult patients with with atrophied posterior mandibular ridge
- both sexes
- NO intra oral soft and hard tissue pathology
- NO systematic that contraindicate implant placement
Exclusion Criteria:
- Presence pathological lesion
- Heavy smokers more than 20 cigarettes per day.
- patients with systemic disease that may affect normal healing
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: computer gaiuded IAN
Computer guided surgical technique
|
Tthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique
|
Experimental: Classical technique
Non computer guided surgical technique
|
Tthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the neurosensory alteration- sensation over time subjective(a scale 1-10)
Time Frame: 1 year
|
assessing the sensation regaining over time subjective (a scale 1-10 )
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant stability
Time Frame: At the placement and after exposure ( up to 6 months )
|
Measurements of the implant stability immediately after placement by osstell
|
At the placement and after exposure ( up to 6 months )
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
January 1, 2019
Primary Completion (Actual)
March 20, 2020
Study Completion (Actual)
March 20, 2020
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
September 12, 2018
First Posted (Actual)
September 13, 2018
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 17, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 14422016552019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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