Maintenance and Cost Effectiveness of Cendres Metaux Locator (CM-LOC) Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures (MCRB)

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

Study Overview

• Status: Unknown
• Conditions: Completely Edentulous
• Intervention / Treatment: Device: cm-loc attachment; Device: ball attachment

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo Universty
    • Contact: cebd; Phone Number: 2364 2938

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cm-loc attachment; cm-loc attachment is a new attachment for dental implants and connect to the denture with resin matrix as housing	Device: cm-loc attachment; cm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture
Active Comparator: ball attachment; ball attachment is the most common attachment for dental implants and connect to the denture by nylon cap and metal housing	Device: ball attachment; ball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of prosthodontic Maintenance events	the number of the patient visits to the doctor to make maintenance for his implant supported overdenture	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: single implant retained mandibular overdenture
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: CEBD-CU-2016-09-196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No