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Completed
NCT02417337
Efficacy of Different Drugs to Control Post Root Canal Treatment Pain
Conditions: Pain, Postoperative Pain, Irreversible Pulpitis
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 185
Sponsor: University of Khartoum
Location: University of Khartoum, Faculty of Dentistry, Khartoum
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT02417337). StuddyBuddy aggregates publicly available trial information.