Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis
NCT ID: NCT04202406
Last Updated: 2021-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2021-01-09
2021-07-11
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Acetaminophen, codeine,and caffeine
Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine.
Acetaminophen and codeine and caffeine
The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.
Acetaminophen
Oral single dose of 1000mg acetaminophen.
Acetaminophen
The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.
Placebo
Maize starch.
Placebo
The patient will receive placebo (starch) 1hour before treatment.
Interventions
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Acetaminophen and codeine and caffeine
The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.
Acetaminophen
The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.
Placebo
The patient will receive placebo (starch) 1hour before treatment.
Eligibility Criteria
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Inclusion Criteria
2. Patients with mandibular molar with symptomatic irreversible pulpitis.
3. Systemically- healthy patients.
4. Patients who agree to attend for recall appointments and provide a written consent.
Exclusion Criteria
2. Patients had allergies to any of test medications.
3. Patients had taken analgesics medication within the last 6 hours.
4. Moderate or severe marginal periodontitis i.e. pocket probe\>3mm.
5. Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease
18 Years
50 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Alaa Mohammed Abdallah Morsi
Post graduate student, Department of Endodontics, Faculty of Dentistry,Cairo University
Principal Investigators
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Alaa M. Morsi
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Faculty of dentistry Cairo university
Giza, Non-US/Non-Canadian, Egypt
Countries
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References
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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.
Cohen 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.
Simpson 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.
Other Identifiers
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CEBD-CU-2019-03-13
Identifier Type: -
Identifier Source: org_study_id
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