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Completed

NCT Number: NCT01590485

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

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

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Key information

Conditions

Post-treatment Pain Following Root Canal Therapy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zahedan university of medical sciences, Vice-chancellor for research

Zahedan, 98167-43463, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

starch

Other

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

saffron

Other

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

Other names: Crocus sativus

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Zahedan University of Medical Sciences

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 3, 2012
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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