Post-treatment Pain Following Root Canal TherapyNCT01590485
Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps
A study testing starch and saffron in people with Post-treatment Pain Following Root Canal Therapy, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-treatment Pain Following Root Canal Therapy
- What is being tested?
- starch and saffron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteIran
- Study dates
- May 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients who have at least one vital tooth with one root canal and moderate to severe pain
Who cannot join
- teeth with periapical lesions
- patients with history of:
- allergy to saffron
- diabetes mellitus
- cardiovascular disorders
- kidney and liver diseases
Show all 10Show fewer
- blood and hormonal disorders
- electrolyte imbalance
- women in pregnancy or breast feeding period and
- use of analgesics or opioids during 4 hours before treatment
Trial locations and contacts
1 site in 1 country.
Iran1 site
Zahedan university of medical sciences, Vice-chancellor for research
Zahedan, 98167-43463
About this study
The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth.
Read the 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.
- Being tested
- starch, saffron
- Keywords
- pain, root canal therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
starchOther
100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
saffronOther
Also called Crocus sativus
100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Starch capsule | Placebo comparator | starch with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) Receives: Other: starch |
| Saffron capsule | Active comparator | saffron with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) Receives: Other: saffron |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in VAS score
Patients will record their pain intensity in each time period according to Visual Analog Scale (VAS)
Measured: Every 6 hours after treatment completion up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-treatment Pain Following Root Canal TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaveh Oloomi, DDS, MS, Zahedan University of Medical Sciences
- Investigators
- Kaveh Oloomi, DDS, MS, Principal investigator, Zahedan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590485
- Sponsor's protocol ID
- pain control by saffron
- Status last verified
- Jan 2013
- First submitted
- 27 Apr 2012
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps
- ClinicalTrials.gov ID
- NCT01590485
- Acronym / sponsor ID
- pain control by saffron
- Keywords
- pain, root canal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starch capsule | Placebo comparator | Other: starchstarch with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) |
| Saffron capsule | Active comparator | Other: saffronsaffron with dose of 100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients who have at least one vital tooth with one root canal and moderate to severe pain
Key exclusion criteria (10 listed)
- teeth with periapical lesions
- patients with history of:
- women in pregnancy or breast feeding period and
- use of analgesics or opioids during 4 hours before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| starch100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) | Other | Starch capsule |
| saffronAlso: Crocus sativus100 mg in each capsule every 6 hours up to 48 hours (400 mg/day) | Other | Saffron capsule |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaveh Oloomi, DDS, MS principal investigator
Zahedan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing starch and saffron in people with Post-treatment Pain Following Root Canal Therapy, run by Zahedan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in VAS score (time frame: Every 6 hours after treatment completion up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.