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

Completely Edentulous Clinical Trial

— MCRB  

Official title:

Maintenance and Cost Effectiveness of CM-LOC Resin Matrix Versus Ball Nylon Matrix Attachment Retaining Single Implant Mandibular Complete Overdentures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02907515
• Other study ID #: CEBD-CU-2016-09-196
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 15, 2016
• Start date: February 2016

Study information

• Verified date: September 2016
• Source: Cairo University
• Contact: amr ahmed naguib, ass. lecturer
• Phone: 00201000406809
• Email: amr_naguib[@]hotmail.com
• Is FDA regulated: No
• Health authority: Germany:Christian-Albrechts University
• Study type: Interventional

Clinical 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 retain its superiority over the ball attachments intraorally regarding the prosthetic complications in single implant retained overdenture like in 2 IOD

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 69 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Completely Edentulous

Intervention

Device:
• cm-loc attachment
cm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture
• ball attachment
ball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture

Locations

Country	Name	City	State
Egypt	Cairo Universty	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of prosthodontic Maintenance events	the number of the patient visits to the doctor to make maintenance for his implant supported overdenture	1 year	No
Secondary	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	No