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

January 28, 2013 updated by: Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences
The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Zahedan, Iran, Islamic Republic of, 98167-43463
        • Zahedan university of medical sciences, Vice-chancellor for research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Crocus sativus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in VAS score
Time Frame: Every 6 hours after treatment completion up to 48 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zahedan University of Medical Sciences

Investigators

  • Principal Investigator: Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

May 1, 2012

First Posted (ESTIMATE)

May 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • pain control by saffron

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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