NCT03008317

Brief Summary

a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.

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
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

December 20, 2016

Last Update Submit

December 30, 2016

Conditions

Polyetheretherketone

Outcome Measures

Primary Outcomes (1)

  • microbial culture using number of clonies after insertion by 3 months

    microbial adhesion will be measured using continous cultures to assess number of colonies

    one year

Study Arms (2)

non metallic

ACTIVE COMPARATOR

PEEK denture base,

Device: PEEK

metallic denture base

PLACEBO COMPARATOR

cobalt chromium alloy denture base

Device: PEEK

Interventions

PEEKDEVICE

a metallic denture base

Also known as: polyetheretherketone denture base, cobalt chromium alloy denture base
metallic denture basenon metallic

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients are medically free

You may not qualify if:

  • patients with badly broken abutments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

December 20, 2016

First Posted

January 2, 2017

Study Start

September 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-12