Completely EdentulousMCRBNCT02907515
Maintenance and Cost Effectiveness of Cendres Metaux Locator (CM-LOC) Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures
A study testing cm-loc attachment and ball attachment in people with Completely Edentulous, run by Cairo University at 1 site in Egypt.
Trial summary
The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2 IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant overdentures are proven to be a successful treatment option for older edentulous adults but we need to know if the CM-LOC attachment will… Read more about this study
- Who is it for?
- Ages 50 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Completely Edentulous
- What is being tested?
- cm-loc attachment and ball attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Mar 2018
- 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 50 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous male or female patients between the ages of 50 to 69.
- No contraindications for implantation.
- Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
- Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al[1] 1999). This will be confirmed by the CBCT.
- Patients seeking to install a single symphyseal implant and for whom new dentures will be constructed.
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- Patients, who are dissatisfied with the retention and stability of their technically satisfactory dentures.
- Patients, who already have existing maxillary and mandibular complete dentures, and after examination of the mandibular dentures, it is found that there are technical problems with regard to denture design and/or occlusion; then new maxillary and mandibular dentures will be fabricated
- All patients should have adapted to their dentures for at least six weeks before being included in the trial.
- Patients providing written informed consents to participate in the trial and this will be done before the scheduled date for implant installation.
Who cannot join
- Patients with a systemic or local contra-indication for implant placement.
- Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
- Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
- Incompliant and not cooperative patients.
- Patients smoking more than 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Universty
Cairo, Cairo Governorate
cebd, 2364 2938
About this study
Official title: Maintenance and Cost Effectiveness of CM-LOC Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures
The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2 IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant overdentures are proven to be a successful treatment option for older edentulous adults but we need to know if the CM-LOC attachment will retain its superiority over the ball attachments intraorally regarding the prosthetic complications in single implant retained overdenture like in 2 IOD
- Conditions
- Completely Edentulous
- Being tested
- cm-loc attachment, ball attachment
- Keywords
- single implant retained mandibular overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cm-loc attachmentDevice
cm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture
ball attachmentDevice
ball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture
| Study group | Role | What they receive |
|---|---|---|
| cm-loc attachment | Experimental | cm-loc attachment is a new attachment for dental implants and connect to the denture with resin matrix as housing Receives: Device: cm-loc attachment |
| ball attachment | Active comparator | ball attachment is the most common attachment for dental implants and connect to the denture by nylon cap and metal housing Receives: Device: ball attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of prosthodontic Maintenance events
the number of the patient visits to the doctor to make maintenance for his implant supported overdenture
Measured: 1 year
Secondary outcomes (1)
cost effectiveness (which treatment will cost less money)
amount of usa dollars scale spent on either attachment cm-loc or ball attachment in fabrication and maintenance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely EdentulousStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ahmed Naguib, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907515
- Sponsor's protocol ID
- CEBD-CU-2016-09-196
- Acronym
- MCRB
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance and Cost Effectiveness of CM-LOC Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures
- ClinicalTrials.gov ID
- NCT02907515
- Acronym / sponsor ID
- MCRB / CEBD-CU-2016-09-196
- Conditions
- Completely Edentulous
- Keywords
- single implant retained mandibular overdenture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2018 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- 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.
The single implant overdenture (IOD) represent the simplest form of IODs compared to the 2 IOD which is the traditional gold standard IOD treatment option. Mandibular single-implant overdentures are proven to be a successful treatment option for older edentulous adults but we need to know if the CM-LOC attachment will retain its superiority over the ball attachments intraorally regarding the prosthetic complications in single implant retained overdenture like in 2 IOD
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cm-loc attachment | Experimental | Device: cm-loc attachmentcm-loc attachment is a new attachment for dental implants and connect to the denture with resin matrix as housing |
| ball attachment | Active comparator | Device: ball attachmentball attachment is the most common attachment for dental implants and connect to the denture by nylon cap and metal housing |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Completely edentulous male or female patients between the ages of 50 to 69.
- No contraindications for implantation.
- Each patient has to perform both a random blood sugar and Glycosylated Hemoglobin analysis. Patients with a Glycosylated hemoglobin test HbA1c up to 8% and a normal blood sugar level (79 to 110) or controlled diabetic patients (90-130 fasting according to American Association of Diabetes) will be included.
- Sufficient bone width (≥ 6 mm) in the anterior region to place an implant. It could be either normally present or achieved by bone plateauing. This will be confirmed by cone beam computed tomographic (CBCT) scans.
- Residual bone height ranging from 11-20 mm with the lowest vertical height in the midline of the mandible not less than 13 mm (Class II or III according to McGarry et al[1] 1999). This will be confirmed by the CBCT.
Key exclusion criteria (5 listed)
- Patients with a systemic or local contra-indication for implant placement.
- Satisfied patients with the retention of their mandibular denture as well as unsatisfied patients with their maxillary denture.
- Patient with a mandibular denture height less than 6 mm between the base of the denture and the incisal edge of the central incisors (as measured by a caliper) or with 12 mm crown height space as measured by a ruler from the incisal edge till the crest of the ridge. This will be done from a putty index of the diagnostic set up.
- Incompliant and not cooperative patients.
- Patients smoking more than 10 cigarettes per day
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 |
|---|---|---|
| cm-loc attachmentcm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture | Device | cm-loc attachment |
| ball attachmentball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture | Device | ball attachment |
Primary outcome
number of prosthodontic Maintenance events
Time frame: 1 year
the number of the patient visits to the doctor to make maintenance for his implant supported overdenture
1 secondary outcome
cost effectiveness (which treatment will cost less money)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cm-loc attachment and ball attachment in people with Completely Edentulous, run by Cairo University at 1 site in Egypt.
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 10 inclusion and 5 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 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 amr ahmed naguib, ass. lecturer (00201000406809, amr_naguib@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of prosthodontic Maintenance events (time frame: 1 year). 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 20 Sep 2016.