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Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01590485
First received: April 27, 2012
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Post-treatment Pain Following Root Canal Therapy
 Other: starch
Other: saffron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Zahedan University of Medical Sciences:

Primary Outcome Measures:
  • change in VAS score [ Time Frame: Every 6 hours after treatment completion up to 48 hours ] [ Designated as safety issue: No ]
    Patients will record their pain intensity in each time period according to Visual Analog Scale (VAS)


Enrollment: 36
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Starch capsule
starch with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
 Other: starch
100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
Active Comparator: Saffron capsule
saffron with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
 Other: saffron
100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
Other Name: Crocus sativus

Detailed Description:

Among patients refer to endodontics department of Zahedan Faculty of Dentistry whom with moderate to severe pain in a single canal tooth will be selected and randomly divided in 2 groups of saffron and placebo. After root canal therapy each patient in each group will receive a box of 8 similar capsules. They will use 1 capsule exactly after treatment completion and then each 6 hours up to 48 hours. Patients will record their pain intensity in each time period according to Visual Analog Scale(VAS)and finally mean pain intensity will be compared between 2 groups.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. teeth with periapical lesions

  2. patients with history of:

    • allergy to saffron
    • diabetes mellitus
    • cardiovascular disorders
    • kidney and liver diseases
    • blood and hormonal disorders
    • electrolyte imbalance
  3. women in pregnancy or breast feeding period and
  4. use of analgesics or opioids during 4 hours before treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590485

Locations
Iran, Islamic Republic of
Zahedan university of medical sciences, Vice-chancellor for research
Zahedan, Iran, Islamic Republic of, 98167-43463
Sponsors and Collaborators
Zahedan University of Medical Sciences
Investigators
Principal Investigator: Kaveh Oloomi, DDS, MS Zahedan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Kaveh Oloomi, DDS, MS, Assistant Professor, Zahedan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01590485     History of Changes
Other Study ID Numbers: pain control by saffron
Study First Received: April 27, 2012
Last Updated: January 28, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Zahedan University of Medical Sciences:
pain
root canal therapy

ClinicalTrials.gov processed this record on June 17, 2013