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Comparative effect of saffron extract with Ibuprofen in dental pain management

Comparative effect of saffron petal and stigma extract with Ibuprofen in post endodontic pain management

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013051713354N1
Enrollment
60
Registered
2013-10-29
Start date
2013-05-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Post-treatment pain after root canal therapy. Diseases of pulp and periapical tissues

Interventions

Intervention 1: saffron stigma extract with dose of 10 mg in each pink opaque capsule in 0, 6, 12, 24, 48 h after treatment. Intervention 2: 400 mg ibuprofen in each pink opaque capsule in 0, 6, 12,
Treatment - Drugs
saffron stigma extract with dose of 10 mg in each pink opaque capsule in 0, 6, 12, 24, 48 h after treatment
400 mg ibuprofen in each pink opaque capsule in 0, 6, 12, 24, 48 h after treatment
saffron petal extract with dose of 10 mg in each pink opaque capsule in 0, 6, 12, 24, 48 h after treatment

Sponsors

Zahedan University of Medical Sciences, Vice-chancellor for research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1-vital teeth with one root canal; 2- moderate to severe pain; 3-patients over 18 years old; 4- patients with at least high school education. Exclusion criteria: 1- teeth with periapical lesions based on radiographic; 2- patients with history of allergy to saffron; 3- patients with history of allergy to NSAID; 4- diabetes mellitus, cardiovascular disorders, kidney and liver diseases, blood and hormonal disorders and electrolyte imbalance; 5- use of analgesics or opioids during 4 hours before treatment; 6- women in pregnancy or breast feeding period.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain intensity. Timepoint: 0 - 6 - 12 - 24 and 48 hours after root canal treatment. Method of measurement: Visual Analog Scale (VAS).

Secondary

MeasureTime frame
Lack of pain intensity. Timepoint: 0-6-12-24-48. Method of measurement: Visual Analog Scale(VAS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Bazrafshan

Zahedan University of Medical Sciences

mojtaba_bazrafshan@yahoo.com+98 54 1341 6708

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026