PulpitisNCT03339544
Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis
A study testing Celebrex premedication in people with Pulpitis, run by Cairo University.
Trial summary
Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis
- What is being tested?
- Celebrex premedication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to Dec 2019
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically free patients
- Patients able to understand Visual Analogue Scale and sign the informed conset
- Mandibular molar teeth with:
- Preoperative sharp pain
- Vital pulp tissue
- Normal peripaical radiographic appearance or slight widening of the lamina dura
Who cannot join
- Patients allergic to NSAIDS
- Pregnant females
- Patients having significant systemic disorder
- Patients with psychological disturbances
- Patients with bruxism or clenching
- Teeth that have:
Show all 12Show fewer
- Associated with swelling or fistulous tract
- Acute or chronic periapical abscess
- Greater than grade I mobility
- Periodontitis
- No possible restorability
- previous endodontic treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial
Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits
Read the detailed description
Owing to the painful nature of endodotnic treatment in teeth with irreversible pulpits, administration of an analgesic and anti-inflammatory could help to lessen the perception of pain, hence decreasing the patient apprehension.
Previous clinical trials have shown that the use of NSAIDS as a premedication prior to endodontic treatment was effective in reducing the pain and increasing the anesthetic success, since as high as 80% of the patients with pre-operative pain experience pain after endodontic treatment.
In this study, Celebrex (Celecoxib) 200mg will be given to the patients 1 hour before initiation of the treatment, and its effect on reducing the pain will be compared with a placebo.
Celebrex being a selective COX-2 inhibitor, it will spare the physiological tissue prostaglandin production while inhibiting the inflammatory prostaglandin production thus allow for effective analgesia with fewer side effects than Non-Selective NSAIDS (nsNSAIDS).
- Conditions
- Pulpitis
- Being tested
- Celebrex premedication, Placebo
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celebrex premedicationDrug
Also called Celecoxib
celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
PlaceboDrug
placebo is given as a tablet before initiation of endodontic treatment
| Study group | Role | What they receive |
|---|---|---|
| Celebrex premedication | Experimental | Celebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain Receives: Drug: Celebrex premedication |
| Placebo tablets | Placebo comparator | placebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity (intra-operative pain)
pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)
Measured: 1 hour after administration of the drug up to 2 hours till the end of endodontic treatment
Secondary outcomes (2)
alleviation of pain severity
severity of pain is measured by Visual Analogue Scale
Measured: 24 hours
number of analgesic tablets taken by the patient after endodontic treatment
counting the number of analgesic tablets taken by the patient after the treatment
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completionDec 2019 (estimated)
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Khaled Mohamed Ezzat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339544
- Sponsor's protocol ID
- celebrex premedication
- Status last verified
- Nov 2017
- First submitted
- 1 Nov 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee Y, Rodriguez C, Dionne RA. The role of COX-2 in acute pain and the use of selective COX-2 inhibitors for acute pain relief. Curr Pharm Des. 2005;11(14):1737-55. doi: 10.2174/1381612053764896.
PubMed 15892672Lapidus D, Goldberg J, Hobbs EH, Ram S, Clark GT, Enciso R. Effect of premedication to provide analgesia as a supplement to inferior alveolar nerve block in patients with irreversible pulpitis. J Am Dent Assoc. 2016 Jun;147(6):427-37. doi: 10.1016/j.adaj.2016.01.006. Epub 2016 Mar 4.
PubMed 26952243
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Celebrex Pre-medication on the Intra and Post-treatment Endodontic Pain in Teeth With Symptomatic Irreversible Pulpitis: Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03339544
- Acronym / sponsor ID
- celebrex premedication
- Conditions
- Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 13 Nov 2017 (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.
Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits
Detailed description
Owing to the painful nature of endodotnic treatment in teeth with irreversible pulpits, administration of an analgesic and anti-inflammatory could help to lessen the perception of pain, hence decreasing the patient apprehension.
Previous clinical trials have shown that the use of NSAIDS as a premedication prior to endodontic treatment was effective in reducing the pain and increasing the anesthetic success, since as high as 80% of the patients with pre-operative pain experience pain after endodontic treatment.
In this study, Celebrex (Celecoxib) 200mg will be given to the patients 1 hour before initiation of the treatment, and its effect on reducing the pain will be compared with a placebo.
Celebrex being a selective COX-2 inhibitor, it will spare the physiological tissue prostaglandin production while inhibiting the inflammatory prostaglandin production thus allow for effective analgesia with fewer side effects than Non-Selective NSAIDS (nsNSAIDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celebrex premedication | Experimental | Drug: Celebrex premedicationCelebrex is a NSAID with selective COX-2 inhibition properties, is given as an intervention to assess the pain |
| Placebo tablets | Placebo comparator | Drug: Placeboplacebo tablets to compare the efficacy of Celebrex on the intra-operative and post-operative pain accompanying endodontic treatment of teeth with irreversible pulpits |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Medically free patients
- Patients able to understand Visual Analogue Scale and sign the informed conset
- Preoperative sharp pain
- Vital pulp tissue
- Normal peripaical radiographic appearance or slight widening of the lamina dura
Key exclusion criteria (12 listed)
- Patients allergic to NSAIDS
- Pregnant females
- Patients having significant systemic disorder
- Patients with psychological disturbances
- Patients with bruxism or clenching
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 |
|---|---|---|
| Celebrex premedicationAlso: Celecoxibcelebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition. | Drug | Celebrex premedication |
| Placeboplacebo is given as a tablet before initiation of endodontic treatment | Drug | Placebo tablets |
Primary outcome
pain intensity (intra-operative pain)
Time frame: 1 hour after administration of the drug up to 2 hours till the end of endodontic treatment
pain intensity during endodontic treatment, measured by Visual Analogue Scale (pain scale)
2 secondary outcomes
alleviation of pain severity
Time frame: 24 hours
number of analgesic tablets taken by the patient after endodontic treatment
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Background: PubMed 15892672Lee Y, Rodriguez C, Dionne RA. The role of COX-2 in acute pain and the use of selective COX-2 inhibitors for acute pain relief. Curr Pharm Des. 2005;11(14):1737-55. doi: 10.2174/1381612053764896.
- Results publication: PubMed 26952243Lapidus D, Goldberg J, Hobbs EH, Ram S, Clark GT, Enciso R. Effect of premedication to provide analgesia as a supplement to inferior alveolar nerve block in patients with irreversible pulpitis. J Am Dent Assoc. 2016 Jun;147(6):427-37. doi: 10.1016/j.adaj.2016.01.006. Epub 2016 Mar 4.
- Individual participant dataSharing planned: No
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Pain
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.
Questions about this trial
What is this clinical trial studying?
A study testing Celebrex premedication in people with Pulpitis, 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 6 inclusion and 12 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 13 Nov 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousra Khaled (+201003040660, yousra.aly28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (intra-operative pain) (time frame: 1 hour after administration of the drug up to 2 hours till the end of endodontic treatment). 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 NCT03339544, 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 13 Nov 2017.