Skip to content

Efficacy of Different Drugs to Control Post Root Canal Treatment Pain

Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02417337
Enrollment
170
Registered
2015-04-15
Start date
2012-08-31
Completion date
2015-01-31
Last updated
2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative Pain, Irreversible Pulpitis

Brief summary

Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics are needed to diminish the pain \[1\]. Development of pain after completion of root canal treatment may undermine patients' confidence in the procedure and the clinician \[2\]. Non-steroidal anti-inflammatory drugs are one of the most frequently taken analgesic medications for dental pain. Their popularity attributed to their efficacy in relieving pain and fever and low side effect profile at therapeutic doses \[3\]. Mono-therapy analgesic has a low effect on dental pain. Improvement was performance by combining analgesics with different mechanisms of action without raising any adverse effects \[4\], was effective in controlling moderate to severe pain. The combination of a non-steroidal anti-inflammatory drug (NSAID) and paracetamol has shown additive analgesia for treating dental pain in several studies \[5,6\]. Endodontic treatment with a lower prevalence of postoperative pain is usually the treatment of choice. There have been no controlled dental studies evaluating the additive effects of combining a non-steroidal anti-inflammatory drug with paracetamol. Breivik et al \[6\] & Menhinick et al \[7\] found that a combination of acetaminophen and ibuprofen was more effective than ibuprofen alone in managing postoperative pain. Aim of the present study, to evaluate the efficacy of the paracetamol when used alone and in combinations with three groups of drugs to control postoperative endodontic pain.

Detailed description

Background: Management of pain is challenging part of dental treatment, sometimes pain is a major postoperative symptom after many dental procedures especially for endodontics. The aim of the present randomized clinical trial was to investigate the efficacy of using paracetamol alone and three combinations of non-steroidal anti-inflammatory drugs with paracetamol, to control postoperative endodontics pain. Methodology: 185 patients who had anterior or premolar teeth with irreversible pulpitis without any signs and symptoms of apical periodontitis and with moderate to severe pain. Patients were divided by allocation randomization into five groups. Four experimental groups receiving different medication; group I (single dose of paracetamol); group II (ibuprofen / paracetamol); group III (diclofenac k / paracetamol), group IV (mefenamic acid /paracetamol) and group V (no medication group). The groups received the medication after the first appointment where the pulp removed, and canals fully prepared. Pain intensity was scored based on 10-point VAS before and after treatment for up to 8 hours postoperatively. Sign test used for comparing pain score before and after treatment. This randomized control clinical trial was conducted on patients who were considered potential candidates if they had moderate to severe spontaneous pain of odontogenic origin (40-100 mm on a visual analogue scale, VAS). Patients were selected from those attending the Conservative dentistry clinics in both the University and the Teaching Hospital Emergency Clinic. The medications were prepared in the laboratories of faculty of Pharmacy. Four groups of medications were prepared as follows; Group I: paracetamol 1000mg Group II: ibuprofen 600mg + paracetamol 1000mg, Group III: Mefenamic acid 500mg + Paracetamol 1000mg Group IV: Diclofenac K 50mg + paracetamol 1000 mg

Interventions

PROCEDURERoot Canal Treatment

A standardized endodontic procedures performed.

DRUGParacetamol
DRUGIbuprofen
DRUGDiclofenac

Sponsors

University of Khartoum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patient reported spontaneous pain moderate to severe, ranging from 50 to 100 mm on a VAS (0-100 mm); 2. Adult patients presented for emergency endodontic treatment with a symptomatic maxillary or mandibular tooth (anterior and premolar) with a pulpal diagnosis of Irreversible pulpitis and normal periapex. 3. Patient choose to have root canal treatment for pain of endodontic origin. 4. The patient presented with American Society of Anesthesiologists (ASA) I or II medical history (ASA 1963). 5. The patient had read and thoroughly understood the pain score level sheet

Exclusion criteria

1. Patients below 18 years of age; 2. Analgesic taken within the last 4 hours; 3. History of allergy to NSAIDs, paracetamol or local anaesthetics; 4. History of uncontrolled systemic disease \[gastrointestinal (GI) disorders, oesophageal reflux, active asthma, decreased hepatic function, haemorrhagic disorders, or poorly controlled diabetes mellitus\]. 5. Patients currently taking opioids, monoamine oxidase inhibitors, tricyclic antidepresssants, carbamazepine, diuretics, or anticoagulants; 6. There was history of opioid addiction or abuse; and 7. Pregnant or nursing female patients.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of different Drugs to Control Post Root Canal Treatment Pain as measured by Visual Analogue Scale.8 hoursThe patients were asked to make entries on the VAS (numerical score) every hour for the first 4 hours after taking the medication and then every 2 hours following that; a total of six entries over 8 hours.

Countries

Sudan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026