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

NCT02861313 | Completed

• 1 other identifier: CEBD-CU-2016-07-175
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Implant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change in modified gingival index

  from baseline up to 5 years

• change in plaque index

  from baseline up to 5 years

• modified bleeding index

  from baseline up to 5 years

Study Arms (2)

CM LOC attachment

EXPERIMENTAL

CM LOC attachment other names: resin matrix attachment

Device: CM LOC attachment

ball attachment

ACTIVE COMPARATOR

ball attachment other names metallic ball attachment

Device: ball attachment

Interventions

CM LOC attachment DEVICE

CM LOC attachment

Also known as: resin matrix attachment

CM LOC attachment

ball attachment DEVICE

Ball attachment

Also known as: metallic ball attachment

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:

• 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.

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)

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

Cairo, +02, Egypt

Location

Study Officials

• marwa AA mohammed, A lecturer

  non affliated

  PRINCIPAL INVESTIGATOR

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: Assisstant Lecturer

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 10, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: April 1, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

EG (1)