NCT04231955

Brief Summary

Patients with symptomatic teeth who applied endodontic clinic between April 2019 and December 2019 for root canal treatment were enrolled in this study. All patients were asked to fill four different rating scales: numerical rating scale, visual analogue scale, color analogue scale and faces rating scale for their relevant tooth which is symptomatic and need of root canal treatment. The four scales were then compared statistically.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 9, 2019

Last Update Submit

January 20, 2020

Conditions

Keywords

numerical rating scalevisual analogue scalecolor analogue scalefaces rating scalepain intensity

Outcome Measures

Primary Outcomes (5)

  • numerical rating scale

    pain intesity level of patients were recorded on a scale from 0 (no pain) to 10 (worst pain posbile)

    through study completion, an average of 1 year

  • visual analogue scale

    Patients were asked to mark their pain intesity level on a 10 cm line with one end indicating "no pain" and the other end "worst pain possible". The distance between "no pain" and the mark indicates the pain intesity level.

    through study completion, an average of 1 year

  • color analogue scale

    Patients were asked to mark their pain intesity level on a 10 cm color changing line with one end indicating "no pain" and the other end "worst pain possible". The distance between "no pain" and the mark indicates the pain intesity level.

    through study completion, an average of 1 year

  • faces rating scale

    faces rating scale consists of 6 faces with the first face indicating "no pain" and the last face indicating "worst pain possbile"

    through study completion, an average of 1 year

  • comparison of four rating scales

    all four pain rating scales (numerical rating scale, visual analogue scale, color analogue scale, faces rating scale) were compared to analyze correlation.

    through study completion, an average of 1 year

Study Arms (1)

pain rating scales

EXPERIMENTAL

patients were asked to marked their pain intensity level on numerical rating scale between 0 and 10, on visual analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible". on color analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible"and color change towards to "worst pain possible" end and on a faces rating scale which consisted of six different faces representing different levels of pain intensity with the first face indicating "no pain" whilst last face indicating "worst pain possible". The result was recorded as pain intensity level.

Diagnostic Test: numerical rating scaleOther: visual analogue scaleOther: color analogue scaleOther: faces rating scale

Interventions

numerical rating scaleDIAGNOSTIC_TEST

patients were asked to marked their pain intensity level on numerical rating scale between 0 and 10 and the result was recorded as pain intensity level.

Also known as: NRS
pain rating scales

Patients were asked to marked their pain intensity level on visual analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible". Then the distance between no pain end and patients' mark was measured and recorded as pain intensity level.

Also known as: VAS
pain rating scales

Patients were asked to marked their pain intensity level on color analogue scale, a straight line with one end indicating "no pain" and the other end indicating "worst pain possible"and color change towards to "worst pain possible" end. Then the distance between no pain end and patients' mark was measured and recorded as pain intensity level.

Also known as: CAS
pain rating scales

Patients were asked marked their pain on a faces rating scale which consisted of six different faces representing different levels of pain intensity with the first face indicating "no pain" whilst last face indicating "worst pain possible". The result was recorded as pain intensity level.

Also known as: FRS
pain rating scales

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic teeth which is in need of root canal treatment

You may not qualify if:

  • systemic diseases
  • age \<18 and \>80
  • being able to understand and accept the study protocol with a written consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University School of Dentistry

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (4)

  • Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  • Price DD, Bush FM, Long S, Harkins SW. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994 Feb;56(2):217-226. doi: 10.1016/0304-3959(94)90097-3.

  • Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

  • Kremer E, Atkinson HJ, Ignelzi RJ. Measurement of pain: patient preference does not confound pain measurement. Pain. 1981 Apr;10(2):241-248. doi: 10.1016/0304-3959(81)90199-8.

MeSH Terms

Conditions

PainToothache

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic DiseasesFacial Pain

Study Officials

  • Tan F EYUBOGLU, PhD, DDS

    Assistant Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: all 50 patients marked their pain intensity levels of their relevant tooth in four different rating scales.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 9, 2019

First Posted

January 18, 2020

Study Start

May 1, 2019

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

IPD will not be shared.

Locations