Complete EdentulismNCT03930862
Ball and Socket Versus Locator Attachment Retained Implant Overdentures
A study testing Locator Attachment (positioner) in people with Complete Edentulism, run by Lamees Hosam Ramadan.
Trial summary
Will the use of locator attachment influence the muscle efficacy when compared to ball and socket attachment in mandibular implant overdenture? ' Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- Locator Attachment (positioner)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Young patients.
- Diseases affecting neuromuscular coordination.
- TMJ diseases.
- Soft tissue abnormalities.
- Bony exostosis.
- Parathyroid dysfunction
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- uncontrolled Diabetes
- Radiotherapy to the neck or head
- Pregnancy.
- Drug and alcohol dependency.
- Smokers.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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? '
Read the 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.
- Conditions
- Complete Edentulism
- Being tested
- Locator Attachment (positioner)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locator Attachment (positioner)Device
intra oral attachment
| Study group | Role | What they receive |
|---|---|---|
| ball and socket | Active comparator | It is an attachment retaining implant overdentures to increase retention and stability of the denture Receives: Device: Locator Attachment (positioner) |
| Locator attachment | Experimental | attachment retaining implant overdentures Receives: Device: Locator Attachment (positioner) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Activity
Digital Electromyogram
Measured: 6 month
Secondary outcomes (1)
Patient Satisfaction: questionnaire
questionnaire from zero to 10 where zero is completely unsatisfied and 10 is highly satisfied
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start15 Sep 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lamees Hosam Ramadan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lamees Hosam Ramadan, Cairo University
- Investigators
- Nada Sherine, PhD, Study director, Lecturer of Prosthdontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930862
- Sponsor's protocol ID
- Muscle activity
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Muscle Activity and Patients Satisfaction on Implants Supported Overdenture Using Ball and Socket Versus Locator Attachment
- ClinicalTrials.gov ID
- NCT03930862
- Acronym / sponsor ID
- Muscle activity
- Conditions
- Complete Edentulism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Lamees Hosam RamadanUniversity, hospital or other
- Study start
- 15 Sep 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Will the use of locator attachment influence the muscle efficacy when compared to ball and socket attachment in mandibular implant overdenture? '
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ball and socket | Active comparator | Device: Locator Attachment (positioner)It is an attachment retaining implant overdentures to increase retention and stability of the denture |
| Locator attachment | Experimental | Device: Locator Attachment (positioner)attachment retaining implant overdentures |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- Young patients.
- Diseases affecting neuromuscular coordination.
- TMJ diseases.
- Soft tissue abnormalities.
- Bony exostosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locator Attachment (positioner)intra oral attachment | Device | Locator attachment, ball and socket |
Primary outcome
Muscle Activity
Time frame: 6 month
Digital Electromyogram
1 secondary outcome
Patient Satisfaction: questionnaire
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nada Sherine, PhD study director
Lecturer of Prosthdontics
Questions about this trial
What is this clinical trial studying?
A study testing Locator Attachment (positioner) in people with Complete Edentulism, run by Lamees Hosam Ramadan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lamees Hosame, Master (020-1020111367, Lamees_bota@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Activity (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.