Symptomatic Irreversible PulpitisNCT04202406
Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis
A study testing Acetaminophen and codeine and caffeine and Acetaminophen in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of preoperative administration of acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve block versus bacetaminophen alone or placebo in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Acetaminophen and codeine and caffeine and Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jan 2021to 11 Jul 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aging between 18-50 years old.
- Patients with mandibular molar with symptomatic irreversible pulpitis.
- Systemically- healthy patients.
- Patients who agree to attend for recall appointments and provide a written consent.
Who cannot join
- Pregnant or lactating female patients.
- Patients had allergies to any of test medications.
- Patients had taken analgesics medication within the last 6 hours.
- Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
- Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry Cairo university
Giza, Non-US/Non-Canadian, 11433
About this study
Official title: Effect of Preoperative Acetaminophen-Codeine-Caffeine Combination on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis: Randomized Double-blind Controlled Trial
The aim of the study is to evaluate the effect of preoperative administration of acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve block versus bacetaminophen alone or placebo in patients with symptomatic irreversible pulpitis.
Read the detailed description
After ensuring eligibility, patients will be given premedication 1hr before treatment,which will be done in single visit.
After 1 hour, Pretreatment pain "pain after administration of analgesic or placebo" will be recorded using 0-10 numerical rating scale (NRS) .
Local anesthesia will, then, be done through inferior alveolar nerve block using 1.8 ml Mepivacaine.
The teeth will be isolated using rubber dam and access cavity will be prepared using #2 high-speed round bur.
The patients will be asked to rate their pain on the NRS. The degree of pain during access preparation and/or instrumentation will be recorded.
Success will be defined as no pain or mild pain during endodontic access preparation and/or instrumentation. Any pain more than no pain or mild pain will considered a failure.
The patients will be instructed to return after 2 days to complete the treatment procedures.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Acetaminophen and codeine and caffeine, Acetaminophen, Placebo
- Keywords
- Postoperative pain, Paracetamol, Placebo, Single visit root canal treatment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen and codeine and caffeineDrug
The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.
AcetaminophenDrug
The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.
PlaceboDrug
The patient will receive placebo (starch) 1hour before treatment.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen, codeine,and caffeine | Experimental | Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine. Receives: Drug: Acetaminophen and codeine and caffeine |
| Acetaminophen | Experimental | Oral single dose of 1000mg acetaminophen. Receives: Drug: Acetaminophen |
| Placebo | Placebo comparator | Maize starch. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.
Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
Measured: During the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start9 Jan 2021
- Primary completion10 May 2021
- Study completion11 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Symptomatic 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohammed Abdallah Morsi, Cairo University
- Investigators
- Alaa M. Morsi, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04202406
- Sponsor's protocol ID
- CEBD-CU-2019-03-13
- Status last verified
- Jul 2021
- First submitted
- 16 Dec 2019
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.
PubMed 17185119Cohen HP, Cha BY, Spangberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3. doi: 10.1016/S0099-2399(06)81366-X.
PubMed 8245762Simpson M, Drum M, Nusstein J, Reader A, Beck M. Effect of combination of preoperative ibuprofen/acetaminophen on the success of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis. J Endod. 2011 May;37(5):593-7. doi: 10.1016/j.joen.2011.02.015. Epub 2011 Mar 22.
PubMed 21496654
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Acetaminophen-Codeine-Caffeine Combination on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis: Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04202406
- Acronym / sponsor ID
- CEBD-CU-2019-03-13
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Postoperative pain, Paracetamol, Placebo, Single visit root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Jan 2021 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 17 Dec 2019 (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 the study is to evaluate the effect of preoperative administration of acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve block versus bacetaminophen alone or placebo in patients with symptomatic irreversible pulpitis.
Detailed description
After ensuring eligibility, patients will be given premedication 1hr before treatment,which will be done in single visit.
After 1 hour, Pretreatment pain "pain after administration of analgesic or placebo" will be recorded using 0-10 numerical rating scale (NRS) .
Local anesthesia will, then, be done through inferior alveolar nerve block using 1.8 ml Mepivacaine.
The teeth will be isolated using rubber dam and access cavity will be prepared using #2 high-speed round bur.
The patients will be asked to rate their pain on the NRS. The degree of pain during access preparation and/or instrumentation will be recorded.
Success will be defined as no pain or mild pain during endodontic access preparation and/or instrumentation. Any pain more than no pain or mild pain will considered a failure.
The patients will be instructed to return after 2 days to complete the treatment procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen, codeine,and caffeine | Experimental | Drug: Acetaminophen and codeine and caffeineOral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine. |
| Acetaminophen | Experimental | Drug: AcetaminophenOral single dose of 1000mg acetaminophen. |
| Placebo | Placebo comparator | Drug: PlaceboMaize starch. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aging between 18-50 years old.
- Patients with mandibular molar with symptomatic irreversible pulpitis.
- Systemically- healthy patients.
- Patients who agree to attend for recall appointments and provide a written consent.
Key exclusion criteria (5 listed)
- Pregnant or lactating female patients.
- Patients had allergies to any of test medications.
- Patients had taken analgesics medication within the last 6 hours.
- Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
- Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease
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 |
|---|---|---|
| Acetaminophen and codeine and caffeineThe patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment. | Drug | Acetaminophen, codeine,and caffeine |
| AcetaminophenThe patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment. | Drug | Acetaminophen |
| PlaceboThe patient will receive placebo (starch) 1hour before treatment. | Drug | Placebo |
Primary outcome
Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.
Time frame: During the treatment
Will be recorded by 11 point NRS 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" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"
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 21 Jul 2021.
- Background: PubMed 17185119Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.
- Background: PubMed 8245762Cohen HP, Cha BY, Spangberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3. doi: 10.1016/S0099-2399(06)81366-X.
- Background: PubMed 21496654Simpson M, Drum M, Nusstein J, Reader A, Beck M. Effect of combination of preoperative ibuprofen/acetaminophen on the success of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis. J Endod. 2011 May;37(5):593-7. doi: 10.1016/j.joen.2011.02.015. Epub 2011 Mar 22.
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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.
Alaa M. Morsi principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen and codeine and caffeine and Acetaminophen in people with Symptomatic 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 4 inclusion and 5 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 21 Jul 2021. 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.
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?
Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation. (time frame: During the 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 NCT04202406, which also lists 3 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 21 Jul 2021.