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
  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:


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 April 17, 2014