Irreversible PulpitisPhase 1/2NCT04964622
the Effect of Preoperative Sodium Ibuprofen on Postoperative Endodontic Pain
A Phase 1/2 study testing nurofen in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- nurofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Sep 2022
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients above 18 years old and below 66.
- Male or female
- Patients seeking root canal treatment
- Mandibular posterior molarteeth with Symptomatic irreversible pulpitis .
- Spontaneous pain
- Systematically healthy patient(ASA I,II)
Who cannot join
- Medically compromised patients having significant systemic disorders. (ASA III or IV)
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption
- Internal root resorption
- Vertical root fracture
Show all 17Show fewer
- Periapical lesion
- Pregnancy
- Use of ibuprofen in the last 12 hour
- Bleeding disorder
- Long term corticosteroid use
- Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal therapy.
- Non-restorability
- Temporomandibular joint (TMJ) problems, bruxism, clenching or traumatic occlusion.
- Inability to perceive the given instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preoperative Single Dose of Sodium Ibuprofen Versus Placebo on Post-operative Pain for Patient With Symptomatic Irreversible Pulpitis Related to Mandibular Molar Teeth: Double Blind Randomized Controlled Trial
The aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth.
Read the detailed description
Oral pharmacologic agents have been the primary option, and the use of drugs has increased exponentially. Many pharmacological agents have been used to manage endodontic pain, including Non-steroidal Anti-inflammatory Drugs (NSAIDs),.administration of NSAIDs before root canal treatment will reduce inflammatory process before it begins. NSAIDs are widely used to control post endodontic pain They act by blocking the activity of cyclooxygenase (COX 1 and 2) enzyme. In human dental pulps with irreversible pulpitis, a higher level of expression of COX 2.In cases of irreversible pulpitis NSAIDS can be administered preoperatively since they reduce the level of prostaglandinE2(PGE2) which is responsible for sensitization of nociceptors. Ibuprofen is one of the most commonly used NSAIDs and a potent inhibitor of prostaglandin (PG) synthesis that can manage various pain types and has anti-inflammatory activity. Enhancements in ibuprofen acid's pharmacokinetics have led to the development of ibuprofen salts with a faster dissolution rate and onset of action. These ibuprofen salts.Fast acting ibuprofen like Sodium ibuprofen delivers maximum plasma drug concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen acid formulations
- Conditions
- Irreversible Pulpitis
- Being tested
- nurofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurofenDrug
Also called sodium ibuprofen
tablet
| Study group | Role | What they receive |
|---|---|---|
| nurofen | Other | sodium ibuprofen 1 tablet (256) 30 minutes before treatment administered once (oral) Receives: Drug: nurofen |
| placebo | Placebo comparator | starch tablet 30 minutes before treatment administered once (oral) Receives: Drug: nurofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
pain will be measured by visual analogue scale(VAS). Postoperative pain levels were documented by the patients immediately after obturation, 6, 12, 24 and 48 hours post-treatment. The VAS consists a 10-cm line anchored by 2 extremes, ''no pain'' and ''pain as bad as it could be.'' Patients were asked to make a mark on the line that represents their level of perceived pain. Readings were transformed into categories; no pain (range of 0-4mm), mild pain (range of 5-44mm), moderate pain (range of 45-74mm) and severe pain (range of 75-100mm)
Measured: Post-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 48 hours
Secondary outcomes (1)
need for rescue medication
Amount of analgesics taken by the patient after root canal treatment
Measured: Amount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Dec 2021
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irreversible PulpitisStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patient with symptomatic irriversible pulpitis
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Sobhie Abdalla, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964622
- Sponsor's protocol ID
- postoperative endodontic pain
- Status last verified
- Dec 2022
- First submitted
- 1 Jul 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith EA, Marshall JG, Selph SS, Barker DR, Sedgley CM. Nonsteroidal Anti-inflammatory Drugs for Managing Postoperative Endodontic Pain in Patients Who Present with Preoperative Pain: A Systematic Review and Meta-analysis. J Endod. 2017 Jan;43(1):7-15. doi: 10.1016/j.joen.2016.09.010. Epub 2016 Dec 6.
PubMed 27939729Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, Natanasabapathy V. Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatment - a double-blind, randomized clinical trial. Int Endod J. 2021 Feb;54(2):198-209. doi: 10.1111/iej.13416. Epub 2020 Nov 12.
PubMed 32976660
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Single Dose of Sodium Ibuprofen Versus Placebo on Post-operative Pain for Patient With Symptomatic Irreversible Pulpitis Related to Mandibular Molar Teeth: Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04964622
- Acronym / sponsor ID
- postoperative endodontic pain
- Conditions
- Irreversible Pulpitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 16 Jul 2021 (actual)
- 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 aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth.
Detailed description
Oral pharmacologic agents have been the primary option, and the use of drugs has increased exponentially. Many pharmacological agents have been used to manage endodontic pain, including Non-steroidal Anti-inflammatory Drugs (NSAIDs),.administration of NSAIDs before root canal treatment will reduce inflammatory process before it begins. NSAIDs are widely used to control post endodontic pain They act by blocking the activity of cyclooxygenase (COX 1 and 2) enzyme. In human dental pulps with irreversible pulpitis, a higher level of expression of COX 2.In cases of irreversible pulpitis NSAIDS can be administered preoperatively since they reduce the level of prostaglandinE2(PGE2) which is responsible for sensitization of nociceptors. Ibuprofen is one of the most commonly used NSAIDs and a potent inhibitor of prostaglandin (PG) synthesis that can manage various pain types and has anti-inflammatory activity. Enhancements in ibuprofen acid's pharmacokinetics have led to the development of ibuprofen salts with a faster dissolution rate and onset of action. These ibuprofen salts.Fast acting ibuprofen like Sodium ibuprofen delivers maximum plasma drug concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen acid formulations
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- patient with symptomatic irriversible pulpitis
| Arm | Type | Receives |
|---|---|---|
| nurofen | Other | Drug: nurofensodium ibuprofen 1 tablet (256) 30 minutes before treatment administered once (oral) |
| placebo | Placebo comparator | Drug: nurofenstarch tablet 30 minutes before treatment administered once (oral) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients above 18 years old and below 66.
- Male or female
- Patients seeking root canal treatment
- Mandibular posterior molarteeth with Symptomatic irreversible pulpitis .
- Spontaneous pain
Key exclusion criteria (17 listed)
- Medically compromised patients having significant systemic disorders. (ASA III or IV)
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption
- Internal root resorption
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 |
|---|---|---|
| nurofenAlso: sodium ibuprofentablet | Drug | nurofen, placebo |
Primary outcome
postoperative pain
Time frame: Post-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 48 hours
pain will be measured by visual analogue scale(VAS). Postoperative pain levels were documented by the patients immediately after obturation, 6, 12, 24 and 48 hours post-treatment. The VAS consists a 10-cm line anchored by 2 extremes, ''no pain'' and ''pain as bad as it could be.'' Patients were asked to make a mark on the line that represents their level of perceived pain. Readings were transformed into categories; no pain (range of 0-4mm), mild pain (range of 5-44mm), moderate pain (range of 45-74mm) and severe pain (range of 75-100mm)
1 secondary outcome
need for rescue medication
Time frame: Amount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperatively
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 7 Dec 2022.
- Results publication: PubMed 27939729Smith EA, Marshall JG, Selph SS, Barker DR, Sedgley CM. Nonsteroidal Anti-inflammatory Drugs for Managing Postoperative Endodontic Pain in Patients Who Present with Preoperative Pain: A Systematic Review and Meta-analysis. J Endod. 2017 Jan;43(1):7-15. doi: 10.1016/j.joen.2016.09.010. Epub 2016 Dec 6.
- Results publication: PubMed 32976660Suresh N, Nagendrababu V, Koteeswaran V, Haritha JS, Swetha SD, Varghese A, Natanasabapathy V. Effect of preoperative oral administration of steroids in comparison to an anti-inflammatory drug on postoperative pain following single-visit root canal treatment - a double-blind, randomized clinical trial. Int Endod J. 2021 Feb;54(2):198-209. doi: 10.1111/iej.13416. Epub 2020 Nov 12.
- 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.
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 1/2 study testing nurofen in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
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 17 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 7 Dec 2022. 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 Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
postoperative pain (time frame: Post-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 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 NCT04964622, which also lists 2 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 7 Dec 2022.