NCT03009942

Brief Summary

This study evaluates the nitric oxide and arginase levels in patients with dental implants. Peri-implant sulcular fluid and saliva samples were collected after loading of the implants

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2017

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

1.9 years

First QC Date

January 2, 2017

Last Update Submit

January 2, 2017

Conditions

Implant Loading

Keywords

nitric oxidearginaseloading

Outcome Measures

Primary Outcomes (1)

  • Biochemical parameters (nitric oxide and arginase) in periimplant sulcular fluid and saliva

    The changes in nitric oxide and arginase levels after implant loading were determined.

    Baseline and 1, 3 and 6 months after implant loading

Secondary Outcomes (4)

  • Plaque index

    Baseline and 1, 3 and 6 months after implant loading

  • Gingival index

    Baseline and 1, 3 and 6 months after implant loading

  • Probing depth

    Baseline and 1, 3 and 6 months after implant loading

  • Bleeding on probing

    Baseline and 1, 3 and 6 months after implant loading

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Twenty patients with one or more implants restored with fixed crown prostheses

You may qualify if:

  • Patients with ≥ 20 teeth, no systemic diseases that could affect bone metabolism, no smoking habits, and had one or more implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 4, 2017

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

January 4, 2017

Record last verified: 2017-01