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

Not Applicable

Completed

• Conditions: Post-treatment Pain Following Root Canal Therapy
• Interventions: Other: saffron; Other: starch

• Registration Number: NCT01590485
• Lead Sponsor: Zahedan University of Medical Sciences

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.

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 Timeline

• Study First Submitted: 2012-04-27
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saffron capsule	saffron	saffron with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
Starch capsule	starch	starch with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)

Primary Outcome Measures

Name	Time	Method
change in VAS score	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)

Trial Locations

Locations (1)

Zahedan university of medical sciences, Vice-chancellor for research; 🇮🇷 Zahedan, Iran, Islamic Republic of