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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01590485
Enrollment
36
Registered
2012-05-03
Start date
2012-05-31
Completion date
2013-01-31
Last updated
2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-treatment Pain Following Root Canal Therapy

Keywords

pain, root canal therapy

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.

Interventions

OTHERstarch

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

OTHERsaffron

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

Sponsors

Zahedan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change in VAS scoreEvery 6 hours after treatment completion up to 48 hoursPatients will record their pain intensity in each time period according to Visual Analog Scale (VAS)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026