- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03661658
Inferior Alveolar Nerve Lateralization With Simultaneous Implant Placement Versus the Use of Short Dental Implants
September 5, 2018 updated by: Ehab Ahmed Shams, Cairo University
Assess the long term stability of short dental implants in comparison to standard implants inserted simultaneously with inferior alveolar nerve lateralization.
Study Overview
Status
Unknown
Study Type
Interventional
Enrollment (Anticipated)
8
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
-
-
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Cairo, Egypt
- Recruiting
- Ehab Ahmed Shams
-
Contact:
- Ehab Ahmed Shams, PDS
- Phone Number: 00201005233925
- Email: ehab_ahmed_206@hotmail.com
-
-
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
20 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients with edentulous posterior mandible.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
- Residual alveolar bone width longer than 6 mm height (7-9 mm).
Exclusion Criteria:
- Presence of fenestrations or dehiscence of the residual ridge.
- 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: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Inferior alveolar nerve lateralization with implant placement
|
Inferior alveolar nerve lateralization with simultaneous implant placement in atrophic posterior mandible.
|
|
Experimental: Using short dental implant with atrophic mandible
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Using short dental implant for patients with atrophic posterior mandible.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary stability
Time Frame: 3 months
|
measuring the primary stability using the osstel
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal bone loss
Time Frame: 3 months
|
measuring the marginal bone loss by using CBCT
|
3 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 (Anticipated)
September 1, 2018
Primary Completion (Anticipated)
February 1, 2019
Study Completion (Anticipated)
June 1, 2019
Study Registration Dates
First Submitted
September 2, 2018
First Submitted That Met QC Criteria
September 5, 2018
First Posted (Actual)
September 7, 2018
Study Record Updates
Last Update Posted (Actual)
September 7, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- cairo university 8
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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