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

NCT ID: NCT02907515

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29

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

Conditions

Completely Edentulous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

cm-loc attachment

cm-loc attachment is a new attachment for dental implants and connect to the denture with resin matrix as housing

Group Type: EXPERIMENTAL

cm-loc attachment

Intervention Type: DEVICE

cm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture

ball attachment

ball attachment is the most common attachment for dental implants and connect to the denture by nylon cap and metal housing

Group Type: ACTIVE_COMPARATOR

ball attachment

Intervention Type: DEVICE

ball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture

Interventions

cm-loc attachment

cm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture

Intervention Type: DEVICE

ball attachment

ball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Ahmed Naguib

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo Universty

Cairo, Cairo Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

amr ahmed naguib, ass. lecturer

Role: CONTACT

amr_naguib@hotmail.com

00201000406809

Facility Contacts

cebd

Role: primary

2364 2938

Other Identifiers

CEBD-CU-2016-09-196

Identifier Type: -

Identifier Source: org_study_id