Pulpitis - IrreversibleNCT03006107
Comparison of a Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine of Post-endodontic Pain
A study testing intraligamentary injection piroxicam and Intraligamentary mepevacaine in people with Pulpitis - Irreversible, run by Cairo University.
Trial summary
to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- intraligamentary injection piroxicam and Intraligamentary mepevacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jan 2018
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Medically free patients
- Patient's age between 25-50 years.
- Molar or premolar teeth diagnosed clinically and radiographically with irreversible pulpitis and symptomatic apical periodontitis.
- Positive patient's acceptance for participation in the study.
- Sex include both male and female.
- Patients who can understand Numerical Rating Scale (NRS)
- Patients able to sign informed consent.
Who cannot join
- • Pregnancy or lactation in female patients
- Medically compromised patients.
- Patient with multiple teeth that required endodontic treatment to eliminate the possibility of pain referral.
- Patient with fracture or mobile or mutilated teeth.
Trial locations and contacts
No sites are listed yet.
Sherif A El khodary, Lecturer contact
About this study
Official title: Comparison of the Efficacy of Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine for Management of Post-endodontic Pain in Posterior Teeth
to evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.
Read the detailed description
The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process
- Conditions
- Pulpitis - Irreversible
- Being tested
- intraligamentary injection piroxicam, Intraligamentary mepevacaine
- Keywords
- Irreversible pulpitis, Post endodontic pain, Symptomatic pulpitis pain, Single visit RCT pain, Root canal treatment flare up, Single dose piroxicam, Intraligamentary piroxicam, Intraligamentary mepecaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraligamentary injection piroxicamProcedure or surgery
intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .
The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone
Intraligamentary mepevacaineProcedure or surgery
mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.
| Study group | Role | What they receive |
|---|---|---|
| intraligamentary injection of piroxicam | Experimental | intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .
The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone Receives: Procedure: intraligamentary injection piroxicam |
| Intraligamentary mepevacaine | Active comparator | mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures. Receives: Procedure: Intraligamentary mepevacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.
Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.
Measured: 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 posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Gamal Ahmed, Cairo University
- Investigators
- Angie g Ghoneim, Professor, Study chair, Department of endodontics - Faculty of Oral and Dental medicine - CUmarwa ga ahmed, student, Principal investigator, Department of endodontics - Faculty of Oral and Dental medicine - CU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006107
- Sponsor's protocol ID
- piroxicam _ Mepecaine
- Status last verified
- Dec 2016
- First submitted
- 15 Dec 2016
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Penniston SG, Hargreaves KM. Evaluation of periapical injection of Ketorolac for management of endodontic pain. J Endod. 1996 Feb;22(2):55-9. doi: 10.1016/S0099-2399(96)80272-X.
PubMed 8935018Pharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007
3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105
Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.
PubMed 22432824Torabinejad M, Bakland LK. Prostaglandins: their possible role in the pathogenesis of pulpal and periapical diseases, part 2. J Endod. 1980 Oct;6(10):769-76. doi: 10.1016/S0099-2399(80)80107-5. No abstract available.
PubMed 7005368Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.
PubMed 3863874McNicholas S, Torabinejad M, Blankenship J, Bakland L. The concentration of prostaglandin E2 in human periradicular lesions. J Endod. 1991 Mar;17(3):97-100. doi: 10.1016/S0099-2399(06)81737-1.
PubMed 1940730Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.
PubMed 21902704Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.
PubMed 12148679Maccagno A, Di Giorgio EE, Caston OL, Sagasta CL. Double-blind controlled clinical trial of oral S-adenosylmethionine versus piroxicam in knee osteoarthritis. Am J Med. 1987 Nov 20;83(5A):72-7. doi: 10.1016/0002-9343(87)90855-2.
PubMed 3318443
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Prophylactic Intraligamentary Injection of Piroxicam Versus Mepecaine for Management of Post-endodontic Pain in Posterior Teeth
- ClinicalTrials.gov ID
- NCT03006107
- Acronym / sponsor ID
- piroxicam _ Mepecaine
- Conditions
- Pulpitis - Irreversible
- Keywords
- Irreversible pulpitis, Post endodontic pain, Symptomatic pulpitis pain, Single visit RCT pain, Root canal treatment flare up, Single dose piroxicam, Intraligamentary piroxicam, Intraligamentary mepecaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 30 Dec 2016 (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 evaluate the effect of a single intraligamentary injection of piroxicam on postoperative pain associated with endodontic procedures.
Detailed description
The pain after endodontic treatment is commonly severe in the first 24 hours after treatment, then it will reduce gradually until commonly disappearing after 7-10 days in most cases. Since piroxicam has a half-life of 50 hours in the plasma, it will be effective in controlling the most intense pain which occurs after endodontic treatment It appears that optimal clinical benefits can be achieved by administering drugs such as local anesthetics and NSAIDs before the onset of postoperative pain. Administering these drugs before a surgical or an endodontic procedure may be of benefit for longer procedures or for minimizing peripheral sensitization, which is a result of the cascade of inflammatory mediators that are released by tissue injury and fuel the subsequent inflammatory process
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraligamentary injection of piroxicam | Experimental | Procedure: intraligamentary injection piroxicamintraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone |
| Intraligamentary mepevacaine | Active comparator | Procedure: Intraligamentary mepevacainemepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Medically free patients
Key exclusion criteria (4 listed)
- • Pregnancy or lactation in female patients
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 |
|---|---|---|
| intraligamentary injection piroxicamintraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours . The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone | Procedure or surgery | intraligamentary injection of piroxicam |
| Intraligamentary mepevacainemepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures. | Procedure or surgery | Intraligamentary mepevacaine |
Primary outcome
The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results.
Time frame: up to 48 hours
Primary outcome will be collected by the operator through Numerical Rating Scale (NRS)20 which is an 11-point scale consisting of numbers from 0 through 10; 0 reading represents "no pain" , 1- 3 readings represent "mild pain" , 4- 6 readings represent "moderate pain" , 7- 10 readings represent "severe pain" No or mild pain will be considered as success while moderate or severe pain will be regarded as failure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Background: PubMed 8935018Penniston SG, Hargreaves KM. Evaluation of periapical injection of Ketorolac for management of endodontic pain. J Endod. 1996 Feb;22(2):55-9. doi: 10.1016/S0099-2399(96)80272-X.
- BackgroundPharmacological Strategies to Control Post-operative Endodontic Pain. Dental Research Journal (Vol. 4, No. 2, Autumn-Winter 2007
- Background3. Building effective strategies for the management of endodontic pain. Endodontic Topics 2002, 3, 93-105
- Background: PubMed 22432824Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.
- Background: PubMed 7005368Torabinejad M, Bakland LK. Prostaglandins: their possible role in the pathogenesis of pulpal and periapical diseases, part 2. J Endod. 1980 Oct;6(10):769-76. doi: 10.1016/S0099-2399(80)80107-5. No abstract available.
- Background: PubMed 3863874Cohen JS, Reader A, Fertel R, Beck M, Meyers WJ. A radioimmunoassay determination of the concentrations of prostaglandins E2 and F2alpha in painful and asymptomatic human dental pulps. J Endod. 1985 Aug;11(8):330-5. doi: 10.1016/s0099-2399(85)80039-x. No abstract available.
- Background: PubMed 1940730McNicholas S, Torabinejad M, Blankenship J, Bakland L. The concentration of prostaglandin E2 in human periradicular lesions. J Endod. 1991 Mar;17(3):97-100. doi: 10.1016/S0099-2399(06)81737-1.
- Background: PubMed 21902704Mehrvarzfar P, Abbott PV, Saghiri MA, Delvarani A, Asgar K, Lotfi M, Karamifar K, Kharazifard MJ, Khabazi H. Effects of three oral analgesics on postoperative pain following root canal preparation: a controlled clinical trial. Int Endod J. 2012 Jan;45(1):76-82. doi: 10.1111/j.1365-2591.2011.01950.x. Epub 2011 Sep 8.
- Background: PubMed 12148679Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.
- Background: PubMed 3318443Maccagno A, Di Giorgio EE, Caston OL, Sagasta CL. Double-blind controlled clinical trial of oral S-adenosylmethionine versus piroxicam in knee osteoarthritis. Am J Med. 1987 Nov 20;83(5A):72-7. doi: 10.1016/0002-9343(87)90855-2.
- Individual participant dataSharing planned: No
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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.
Sherif A El khodary, Lecturer contact
Angie g Ghoneim, Professor study chair
Department of endodontics - Faculty of Oral and Dental medicine - CU
marwa ga ahmed, student principal investigator
Department of endodontics - Faculty of Oral and Dental medicine - CU
Questions about this trial
What is this clinical trial studying?
A study testing intraligamentary injection piroxicam and Intraligamentary mepevacaine in people with Pulpitis - Irreversible, run by Cairo University.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marwa ga ahmed, student (01286171420, marwa.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of postoperative pain at 6, 12, 24 and 48 postoperative hours which will be measured by Numeric Rate Scale , where the patient will be asked to rate the progress of pain on the NRS and inform the investigator with the results. (time frame: up to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006107, which also lists 10 linked publications.
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 30 Dec 2016.