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

Oral Health Related Quality of Life and Peri-implant Condition in Single Implant Mandibular Overdenture Retained by CM LOC Versus Ball Attachment: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Implant
• Intervention / Treatment: Device: CM LOC attachment; Device: ball attachment

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)

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, +02
    • Removable Prosthodontic Department, Faculty of Oral and Dental Medicine - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CM LOC attachment; CM LOC attachment other names: resin matrix attachment	Device: CM LOC attachment; CM LOC attachment; Other Names: resin matrix attachment
Active Comparator: ball attachment; ball attachment other names metallic ball attachment	Device: ball attachment; Ball attachment; Other Names: metallic ball attachment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in oral health related quality of life using (oral health impact profile edentulous) questionnaire (OHIP-EDENT)	likert scale from 0-4	from baseline up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in modified gingival index	score measurement from 0-4 where 0 is no inflammation and 4 is sever inflammation	from baseline up to 5 years
change in plaque index	score measurement from 0-3 where 0 denotes absence of plaque, 3 abundant plaque	from baseline up to 5 years
modified bleeding index	score measurement from 0-3 where 0 denotes no bleeding, 3 profuse bleeding	from baseline up to 5 years

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: marwa AA mohammed, A lecturer, non affliated

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 10, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2019
• Last Update Submitted That Met QC Criteria: September 1, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CEBD-CU-2016-07-175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided