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

Zahedan University of Medical Sciences

Status: Completed

Conditions: Post-treatment Pain Following Root Canal Therapy

Treatments: Other: saffron; Other: starch

Study type: Interventional

Funder types: Other

Identifiers

NCT01590485

pain control by saffron

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups, including a placebo group

Starch capsule

Placebo Comparator group

Description:

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

Treatment:

Other: starch

Saffron capsule

Active Comparator group

Description:

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

Treatment:

Other: saffron