Maintenance and Cost Effectiveness of Cendres Metaux Locator (CM-LOC) Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures (MCRB)
Primary Purpose
Completely Edentulous
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cm-loc attachment
ball attachment
Sponsored by
About this trial
This is an interventional health services research trial for Completely Edentulous focused on measuring single implant retained mandibular overdenture
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Cairo UniverstyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cm-loc attachment
ball attachment
Arm Description
cm-loc attachment is a new attachment for dental implants and connect to the denture with resin matrix as housing
ball attachment is the most common attachment for dental implants and connect to the denture by nylon cap and metal housing
Outcomes
Primary Outcome Measures
number of prosthodontic Maintenance events
the number of the patient visits to the doctor to make maintenance for his implant supported overdenture
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02907515
Brief Title
Maintenance and Cost Effectiveness of Cendres Metaux Locator (CM-LOC) Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures
Acronym
MCRB
Official Title
Maintenance and Cost Effectiveness of CM-LOC Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 retain its superiority over the ball attachments intraorally regarding the prosthetic complications in single implant retained overdenture like in 2 IOD
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Completely Edentulous
Keywords
single implant retained mandibular overdenture
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cm-loc attachment
Arm Type
Experimental
Arm Description
cm-loc attachment is a new attachment for dental implants and connect to the denture with resin matrix as housing
Arm Title
ball attachment
Arm Type
Active Comparator
Arm Description
ball attachment is the most common attachment for dental implants and connect to the denture by nylon cap and metal housing
Intervention Type
Device
Intervention Name(s)
cm-loc attachment
Intervention Description
cm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture
Intervention Type
Device
Intervention Name(s)
ball attachment
Intervention Description
ball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture
Primary Outcome Measure Information:
Title
number of prosthodontic Maintenance events
Description
the number of the patient visits to the doctor to make maintenance for his implant supported overdenture
Time Frame
1 year
Secondary Outcome Measure Information:
Title
cost effectiveness (which treatment will cost less money)
Description
amount of usa dollars scale spent on either attachment cm-loc or ball attachment in fabrication and maintenance
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amr ahmed naguib, ass. lecturer
Phone
00201000406809
Email
amr_naguib@hotmail.com
Facility Information:
Facility Name
Cairo Universty
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
cebd
Phone
2364 2938
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Maintenance and Cost Effectiveness of Cendres Metaux Locator (CM-LOC) Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures
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