NCT02952274

Brief Summary

The aim of this study is to compare the ball attachment to the locator attachment regarding the OHRQoL (oral health related quality of life) for completely edentulous patients retaining a mandibular overdenture with a midline placed implant

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

October 31, 2016

Last Update Submit

November 1, 2016

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

  • OHRQoL (oral health related quality of life)

    6 months

Secondary Outcomes (2)

  • Peri-implant Plaque index

    6 months

  • Peri-implant Probing Depth

    6 months

Study Arms (2)

locater attachment

ACTIVE COMPARATOR

mandibular overdenture retained with single midline implant using locator attachment

Device: mandibular overdenture retained with single midline implant using locator attachment

ball attachment

ACTIVE COMPARATOR

mandibular overdenture retained with single midline implant using ball attachment

Device: mandibular overdenture retained with single midline implant using ball attachment

Interventions

mandibular overdenture retained with single midline implant using locator attachmentDEVICE
locater attachment
mandibular overdenture retained with single midline implant using ball attachmentDEVICE
ball attachment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completely edentulous patient
  • Patients having enough bone for an implant length of at least 10 mm
  • No apparent bony mal-relation.
  • No intraoral soft and hard tissue pathology
  • No uncontrolled systematic diseases such as hypertension, diabetes and immunodeficiency.

You may not qualify if:

  • Drug or alcohol abuse,
  • A health condition precluding surgery,
  • Physical reasons that could affect follow-up,
  • Psychiatric problems,
  • Disorders to the implant area related to a history of radiation therapy to the head and neck, neoplasia, or bone augmentation to the implant site.
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Central Study Contacts

Ahmed El-Baz

CONTACT

01011168773ahmedbaz88@gmail.com

Ahmed Sayed

CONTACT

01006410903

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 2, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share