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

NCT02923661 | Unknown

• 1 other identifier: CEBD-CU-2016-09-205
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Edentulous; Dental Implant

Keywords

single implant

Outcome Measures

Primary Outcomes (1)

• patient satisfaction

  patient satisfaction will be measured using a questionnaire

  1 year

Secondary Outcomes (1)

• Marginal bone loss

  1 year

Study Arms (2)

CM LOC attachment group

EXPERIMENTAL

this group will receive CM LOC attachment and lower overdenture attached to it

Device: CM LOC

Ball attachment

ACTIVE COMPARATOR

this group will receive Ball attachment and lower overdenture attached to it

Device: ball attachment

Interventions

CM LOC DEVICE

Also known as: Resin matrix

CM LOC attachment group

ball attachment DEVICE

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.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.

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 University

Cairo, Cairo Governorate, 11351, Egypt

RECRUITING

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Karim M. Fouda, Master

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim M. Fouda, Master

CONTACT

+201001234172; karimfoda@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: October 2, 2016
• First Posted: October 4, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2021
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

EG (1)