Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Overdenture

NCT ID: NCT02861313

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-04-30

Brief Summary

Comparing the quality of life and periimplant condition around a single implant retained mandibular overdenture in two groups one will have a ball attachment and the other is having a (CM-LOC) one.

Detailed Description

Single implant retained mandibular overdenture is considered an economic and simple treatment modality for edentulous subjects. Resin matrix (CM LOC) is one of the low profile attachments which represent a promising retention values with subsequent improvement in chewing ability and in turns enhance patient quality of life.Oral health impact profile for edentulous patient (OHIP-EDENT) is more specific to edentulous subjects.

Peri-implant soft tissue health (bleeding, inflammation, etc...) is a valuable marker to implant success. The study will record different attachment influenced-tissue response and its relation to implant success and oral health related quality of life (OHRQOL)

Conditions

Quality of Life; Implant

Study Design

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

Study Groups

CM LOC attachment

CM LOC attachment other names: resin matrix attachment

Group Type: EXPERIMENTAL

CM LOC attachment

Intervention Type: DEVICE

CM LOC attachment

ball attachment

ball attachment other names metallic ball attachment

Group Type: ACTIVE_COMPARATOR

ball attachment

Intervention Type: DEVICE

Ball attachment

Interventions

CM LOC attachment

CM LOC attachment

Intervention Type: DEVICE

ball attachment

Ball attachment

Intervention Type: DEVICE

Other Intervention Names

resin matrix attachment; metallic ball attachment

Eligibility Criteria

Inclusion Criteria

• 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 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

Marwa Abdelaal Mohammed

Assisstant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

marwa AA mohammed, A lecturer

Role: PRINCIPAL_INVESTIGATOR

non affliated

Locations

Removable Prosthodontic Department, Faculty of Oral and Dental Medicine - Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

CEBD-CU-2016-07-175

Identifier Type: -

Identifier Source: org_study_id