Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment
Primary Purpose
Edentulous, Dental Implant
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CM LOC
ball attachment
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous focused on measuring single implant
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.22This 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 UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CM LOC attachment group
Ball attachment
Arm Description
this group will receive CM LOC attachment and lower overdenture attached to it
this group will receive Ball attachment and lower overdenture attached to it
Outcomes
Primary Outcome Measures
patient satisfaction
patient satisfaction will be measured using a questionnaire
Secondary Outcome Measures
Marginal bone loss
Marginal bone loss will be measured using paralleling radiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02923661
Brief Title
Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment
Official Title
Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
this study was conducted to clarify the effect of two different attachments on patient satisfaction and marginal bone loss. The primary and secondary objectives are to determine patient satisfaction and the marginal bone loss around implant when using CM LOC compared to conventional ball attachment. all the patients will receive a single median implant to which the denture will be loaded upon using the two different attachment systems
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous, Dental Implant
Keywords
single implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CM LOC attachment group
Arm Type
Experimental
Arm Description
this group will receive CM LOC attachment and lower overdenture attached to it
Arm Title
Ball attachment
Arm Type
Active Comparator
Arm Description
this group will receive Ball attachment and lower overdenture attached to it
Intervention Type
Device
Intervention Name(s)
CM LOC
Other Intervention Name(s)
Resin matrix
Intervention Type
Device
Intervention Name(s)
ball attachment
Primary Outcome Measure Information:
Title
patient satisfaction
Description
patient satisfaction will be measured using a questionnaire
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Marginal bone loss
Description
Marginal bone loss will be measured using paralleling radiography
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.22This 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
Karim M. Fouda, Master
Phone
+201001234172
Email
karimfoda@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim M. Fouda, Master
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
11351
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan Ahmed
Phone
+020 2364 2938
Email
hassan.ahmed@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment
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