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Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment

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ClinicalTrials.gov Identifier: NCT02923661
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Karim Fouda, Cairo University

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

Condition or disease Intervention/treatment Phase
Edentulous Dental Implant Device: CM LOC Device: ball attachment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient Satisfaction in Single Implant Mandibular Complete Overdentures Retained by CM LOC Versus Ball Attachment
Study Start Date : February 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2021

Arm Intervention/treatment
Experimental: CM LOC attachment group
this group will receive CM LOC attachment and lower overdenture attached to it
Device: CM LOC
Other Name: Resin matrix

Active Comparator: Ball attachment
this group will receive Ball attachment and lower overdenture attached to it
Device: ball attachment



Primary Outcome Measures :
  1. patient satisfaction [ Time Frame: 1 year ]
    patient satisfaction will be measured using a questionnaire


Secondary Outcome Measures :
  1. Marginal bone loss [ Time Frame: 1 year ]
    Marginal bone loss will be measured using paralleling radiography



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02923661


Contacts
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Contact: Karim M. Fouda, Master +201001234172 karimfoda@hotmail.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt, 11351
Contact: Hassan Ahmed    +020 2364 2938    hassan.ahmed@dentistry.cu.edu.eg   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Karim M. Fouda, Master Cairo University

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Responsible Party: Karim Fouda, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT02923661    
Other Study ID Numbers: CEBD-CU-2016-09-205
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Karim Fouda, Cairo University:
single implant
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases