NCT02474030

Brief Summary

This study was conducted with an aim to know how individual attributes associated to intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and psychological state evaluated by the Profile of Mood States.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.7 years

First QC Date

June 11, 2015

Last Update Submit

March 29, 2016

Conditions

Intraoral Pain Threshold

Outcome Measures

Primary Outcomes (1)

  • pain threshold

    intraoral electrical pain threshold

    20minutes

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteers participants studying or workung at the Nihon University School of Dentistry at Matsudo took part in the study.

You may qualify if:

  • not pacemaker wearers

You may not qualify if:

  • general health problems that could affect the measurement of nerve activity a lack of understanding of written or spoken Japanese

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nihon University School of Dentistry at Matsudo

Matsudo, Chiba, 2718587, Japan

RECRUITING

Central Study Contacts

Nakashima Yoshio, D.D.S

CONTACT

+81-47-360-9375hal-105@hotmail.co.jp

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Removable Prothodontics

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 17, 2015

Study Start

February 1, 2013

Primary Completion

October 1, 2015

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

JP(1)