- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03930862
Ball and Socket Versus Locator Attachment Retained Implant Overdentures
April 29, 2019 updated by: Lamees Hosam Ramadan
Comparison of Muscle Activity and Patients Satisfaction on Implants Supported Overdenture Using Ball and Socket Versus Locator Attachment
Will the use of locator attachment influence the muscle efficacy when compared to ball and socket attachment in mandibular implant overdenture?
'
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
In this study we will use a two different types of attachments in implants overdenture in mandibular completely edentulous patients to increase the retention and stability of the denture and this can be recognized by record the masticatory function of the muscles of the mandibular jaw.
Study Type
Interventional
Enrollment (Anticipated)
12
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 Contact
- Name: Lamees Hosame, Master
- Phone Number: 020-1020111367
- Email: Lamees_bota@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
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Upper and lower completely edentulous patients. Acceptance of the existing denture if it is good, or constructing a new one if it is defected.
Patients with adequate bone quality and quantity. Tooth extracted not less than 6 month.
Exclusion Criteria:
- Young patients.
- Diseases affecting neuromuscular coordination.
- TMJ diseases.
- Soft tissue abnormalities.
- Bony exostosis.
- Parathyroid dysfunction
- uncontrolled Diabetes
- Radiotherapy to the neck or head
- Pregnancy.
- Drug and alcohol dependency.
- Smokers.
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: ball and socket
It is an attachment retaining implant overdentures to increase retention and stability of the denture
|
intra oral attachment
|
Experimental: Locator attachment
attachment retaining implant overdentures
|
intra oral attachment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Activity
Time Frame: 6 month
|
Digital Electromyogram
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Satisfaction: questionnaire
Time Frame: 6 month
|
questionnaire from zero to 10 where zero is completely unsatisfied and 10 is highly satisfied
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nada Sherine, PhD, Lecturer of Prosthdontics
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 15, 2019
Primary Completion (Anticipated)
October 1, 2020
Study Completion (Anticipated)
October 1, 2020
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 26, 2019
First Posted (Actual)
April 29, 2019
Study Record Updates
Last Update Posted (Actual)
May 1, 2019
Last Update Submitted That Met QC Criteria
April 29, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- Muscle activity
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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