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

NCT02907515 | Unknown DMC

• 1 other identifier: CEBD-CU-2016-09-196
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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

Keywords

single implant retained mandibular overdenture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cost effectiveness (which treatment will cost less money)

  1 year

Study Arms (2)

cm-loc attachment

EXPERIMENTAL

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

Device: cm-loc attachment

ball attachment

ACTIVE COMPARATOR

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

Device: ball attachment

Interventions

cm-loc attachment DEVICE

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

cm-loc attachment

ball attachment DEVICE

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

ball attachment

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Universty

Cairo, Cairo Governorate, Egypt

RECRUITING

Central Study Contacts

amr ahmed naguib, ass. lecturer

CONTACT

00201000406809; amr_naguib@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 20, 2016
• Study Start: February 1, 2016
• Primary Completion: March 1, 2018
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)