Post Operative Endodontic PainPhase 2NCT01480752
Reduction of Post-operative Endodontic Pain
A Phase 2 study testing Lornoxicam, normal saline and no injection in people with Post Operative Endodontic Pain, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial summary
To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Endodontic Pain
- What is being tested?
- Lornoxicam, normal saline and no injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 2
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy (ASA I, II);
- Patients with first or second mandibular molars who need endodontic treatment;
- Vital tooth without a history of past endodontic treatment;
- Patients with clinical evidence of irreversible Pulpits with moderate to severe pain;
- Patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images;
- Patients in the age group of 18-65 years old
Who cannot join
- Pregnant or nursing;
- necrotic tooth;
- Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs;
- People who have a history of acute peptic ulcer, during the past 12 months;
- People who have bleeding problems or have been taking anticoagulant drugs over the past month;
- Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Intraligamentary Injection of Lornoxicam on the Intensity of Post-operative Endodontic Pain in the Tooth With Symptomatic Irreversible Pulpitis
To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.
Read the detailed description
sixty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in three groups which all of them will have an inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam and the second group will be injected with 0.4 mL of normal saline( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) ,in third group we will only pretend the injection but actually there is no substance injected ,making the patient believe that there was an injection . Then the patients' pain will be evaluated with visual Analogue Scale analysis (VAS) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.
- Conditions
- Post Operative Endodontic Pain
- Being tested
- Lornoxicam, normal saline, no injection
- Keywords
- In the patients with symptomatic Irreversible Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LornoxicamDrug
Also called Xefo, (904111)
PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection
normal salineDrug
PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection
no injectionDrug
inject nothing after inferior alveolar injection and before root canal therapy
| Study group | Role | What they receive |
|---|---|---|
| Lornoxicam | Active comparator | Not described Receives: Drug: Lornoxicam |
| normal saline | Placebo comparator | Not described Receives: Drug: normal saline |
| no injection | Placebo comparator | Not described Receives: Drug: no injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative endodontic's pain
The measuring method of the pain is VAS(Visual Analogue Scale).
Measured: 6,12,24,48 hours after drug's injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Endodontic PainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandana Abedi Tari, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480752
- Sponsor's protocol ID
- IRCT201108017191N1
- Status last verified
- Jan 2013
- First submitted
- 24 Nov 2011
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Intraligamentary Injection of Lornoxicam on the Intensity of Post-operative Endodontic Pain in the Tooth With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT01480752
- Acronym / sponsor ID
- IRCT201108017191N1
- Conditions
- Post Operative Endodontic Pain
- Keywords
- In the patients with symptomatic Irreversible Pulpitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Nov 2011 (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.
To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.
Detailed description
sixty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in three groups which all of them will have an inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam and the second group will be injected with 0.4 mL of normal saline( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) ,in third group we will only pretend the injection but actually there is no substance injected ,making the patient believe that there was an injection . Then the patients' pain will be evaluated with visual Analogue Scale analysis (VAS) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lornoxicam | Active comparator | Drug: Lornoxicam |
| normal saline | Placebo comparator | Drug: normal saline |
| no injection | Placebo comparator | Drug: no injection |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- healthy (ASA I, II);
- Patients with first or second mandibular molars who need endodontic treatment;
- Vital tooth without a history of past endodontic treatment;
- Patients with clinical evidence of irreversible Pulpits with moderate to severe pain;
- Patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images;
Key exclusion criteria (6 listed)
- Pregnant or nursing;
- necrotic tooth;
- Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs;
- People who have a history of acute peptic ulcer, during the past 12 months;
- People who have bleeding problems or have been taking anticoagulant drugs over the past month;
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 |
|---|---|---|
| LornoxicamAlso: Xefo, (904111)PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection | Drug | Lornoxicam |
| normal salinePDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection | Drug | normal saline |
| no injectioninject nothing after inferior alveolar injection and before root canal therapy | Drug | no injection |
Primary outcome
Post operative endodontic's pain
Time frame: 6,12,24,48 hours after drug's injection
The measuring method of the pain is VAS(Visual Analogue Scale).
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 14 Jan 2013.
Related trials for Post Operative Endodontic Pain
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
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Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
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Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lornoxicam, normal saline and no injection in people with Post Operative Endodontic Pain, run by Islamic Azad University, Sanandaj 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 6 inclusion and 6 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 14 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post operative endodontic's pain (time frame: 6,12,24,48 hours after drug's injection). 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 14 Jan 2013.