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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
Acronym
NSAID
Enrollment
185
Registered
2015-04-15
Start date
2012-08-01
Completion date
2015-01-01
Last updated
2026-06-25

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

Conditions

Irreversible Pulpitis, Pain, Postoperative Pain

Brief summary

Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics are needed to diminish the pain \[Owatz et al 2007\]. Development of pain after completion of root canal treatment may undermine patients' confidence in the procedure and the clinician \[Albashaireh and Alnegrish 1998\]. 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 \[Attar et al 2008\]. 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 \[Mehlisch 2002\], 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 \[Breivik et al1999, Keiser and Hargreaves 2002\]. 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 al1999 & Menhinick et al 2004 found that a combination of acetaminophen and ibuprofen was more effective than ibuprofen alone in managing postoperative pain \[Breivik et al1999 & Menhinick et al 2004\]. 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 endodontic 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 (mefenamic acid /paracetamol), group IV (diclofenac k / 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 by using both verbal rating scale (VRS-4) and numerical rating scale (NRS-11). The pain scores were recorded before the initial endodontic therapy 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 (ranging from 4-10 score based on the numerical rating scale (NRS-11)). 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 and a placebo 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 Group V: Placebo

Interventions

DRUGParacetamol

NSAID

DRUGIbuprofen

NSAID

DRUGDiclofenac

NSAID

OTHERPlacebo

empty double gelatinous capsules, having similar weight and appearance of the medications

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. Spontaneous pain moderate to severe on the verbal rating scale (VRS-4), ranging from 4-10 score based on the numerical rating scale (NRS-11). 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 antidepressants, 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
Pain Score on Numerical Rating Scale of Pain (NRS-11)8 hours(NRS-11) numerical rating scale of pain between 0 (better) and 10 (worse) before and after treatment

Secondary

MeasureTime frameDescription
Mean of Pain Reduction Stratified by Sex and Jaw Type on Numerical Rating Scale (NRS-11)8 hoursNumerical rating scale (NRS-11), (0 better/the least pain score to 10 worse/the maximum pain score), , was done for sex (male or female) and jaw type (maxilla or mandible)

Countries

Sudan

Contacts

STUDY_DIRECTORNeamat Abubakr, BDS,MDSc,PhD

Faculty of Dentistry, University of Khartoum

Participant flow

Recruitment details

The sample was made up of patients attending the clinics of the Faculty of Dentistry, University of Khartoum and the Khartoum Teaching Hospital emergency clinic, which were the setting and location of the trial. The clinical trial dates of recruitment was between August 2012 and August 2014.

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
170 Participants
Age, Continuous33 years
STANDARD_DEVIATION 10.5
Region of Enrollment
Sudan
34 participants
Sex: Female, Male
Female
104 Participants
Sex: Female, Male
Male
15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 330 / 340 / 350 / 34
other
Total, other adverse events
0 / 340 / 330 / 340 / 350 / 34
serious
Total, serious adverse events
0 / 340 / 330 / 340 / 350 / 34

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026