NCT01590485

Brief Summary

The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

April 27, 2012

Last Update Submit

January 28, 2013

Conditions

Post-treatment Pain Following Root Canal Therapy

Keywords

painroot canal therapy

Outcome Measures

Primary Outcomes (1)

  • change in VAS score

    Patients will record their pain intensity in each time period according to Visual Analog Scale (VAS)

    Every 6 hours after treatment completion up to 48 hours

Study Arms (2)

Starch capsule

PLACEBO COMPARATOR

starch with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)

Other: starch

Saffron capsule

ACTIVE COMPARATOR

saffron with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)

Other: saffron

Interventions

starchOTHER

100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)

Starch capsule
saffronOTHER

100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)

Also known as: Crocus sativus
Saffron capsule

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients who have at least one vital tooth with one root canal and moderate to severe pain

You may not qualify if:

  • teeth with periapical lesions
  • patients with history of:
  • allergy to saffron
  • diabetes mellitus
  • cardiovascular disorders
  • kidney and liver diseases
  • blood and hormonal disorders
  • electrolyte imbalance
  • women in pregnancy or breast feeding period and
  • use of analgesics or opioids during 4 hours before treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zahedan university of medical sciences, Vice-chancellor for research

Zahedan, 98167-43463, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Starch

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Kaveh Oloomi, DDS, MS

    Zahedan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 27, 2012

First Posted

May 3, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

IR(1)