Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis

Not Applicable

Completed

• Conditions: Symptomatic Irreversible Pulpitis
• Interventions: Drug: Acetaminophen and codeine and caffeine; Drug: Placebo; Drug: Acetaminophen

• Registration Number: NCT04202406
• Lead Sponsor: Cairo University

Brief 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.

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 Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Study Start: 2021-01-09
• Primary Completion: 2021-05-10
• Status Verified: 2021-07
• Study Completion: 2021-07-11
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Patients aging between 18-50 years old.
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

1. Pregnant or lactating female patients.
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen, codeine,and caffeine	Acetaminophen and codeine and caffeine	Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine.
Placebo	Placebo	Maize starch.
Acetaminophen	Acetaminophen	Oral single dose of 1000mg acetaminophen.

Primary Outcome Measures

Name	Time	Method
Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.	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"

Trial Locations

Locations (1)

Faculty of dentistry Cairo university; 🇪🇬 Giza, Non-US/Non-Canadian, Egypt