Clinical trial NCT06514222: Pain Control Following Third Molar Surgery
Official title: Pain Control Following Impacted Mandibular Third Molar Surgery: A Comparison of the Effectiveness of Two Different Protocols
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Post Operative Pain
Impacted Third Molar Tooth
Keywords: Third molar surgery
Post Operative Pain
Paracetamol
Ibuprofen
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, double-blind, parallel-group, randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: In this study, the investigators recruited patients undergoing surgical removal of impacted third molar teeth. Participants will be randomly divided into two groups Group 1: The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.

Group 2- The patient will receive 400mg ibuprofen and 1000mg Paracetamol at 4 hours in intervals for two days. With a total of 3 doses of ibuprofen and 3 doses of paracetamol per day Then, pain control will be assessed using various primary and secondary outcome scales.

Detailed description: Surgical removal of an impacted mandibular third molar is one of the most common procedures in oral and maxillofacial surgery. Ten million third molars are extracted from approximately 5 million people in the United States each year. Research suggests that wisdom tooth removal has an immediate negative impact on patients' working and social lives: in one study, patients took an average of 1.6 days off work, with over one-third of patients stating that the surgery had affected their performance at work. Postoperative complications may include swelling, bruising, and limited mouth opening, along with difficulty with eating, which can be a major concern to patients and has not been appreciated by healthcare professionals in the past. However, patients are often most concerned about postoperative pain, which may be severe. Approximately one in two patients will experience pain despite analgesic therapy, even one week after surgery. The inflammatory response to surgical trauma is associated with edema, discomfort, dehiscence, and trismus, and these factors may affect the patient's everyday life. The control of these symptoms is frequently based on pharmacological manipulation of local and systemic pain and inflammation mediators. Combining two analgesic agents with distinct mechanisms or sites of action, such as combining a peripherally acting analgesic with a centrally acting analgesic, has been advocated for many years. A common example is the analgesic formulation containing acetaminophen combined with the opioid hydrocodone or paracetamol with ibuprofen. The pain control of single showed that the maximum effect is recorded in the first 2 to 3 hours. Combining two agents tends to increase the effect for 6 to 8 hours. However, as both medication actions commence simultaneously in the latter combination, they are likely to fade in the same way. This may make the patient likely to overdose on such medicine to ensure the continuity of pain relief. This research aims to test the combination of classical pain medication but in a novel alternate way to minimize the dosage and avoid the risk of side effects and toxicity.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years,
2. Need for surgical extraction of at least one fully or partially impacted lower third molar with a degree of difficulty of 5 points or more on the Pedersen scale,
3. ASA I-II status according to the American Society of Anesthesiologists, and
4. No allergy to the drugs under study.

Exclusion Criteria:

1. Pregnancy
2. Breastfeeding
3. ASA III or above
4. Consumption of antibiotics in the week before surgery; and
5. Clinical evidence of acute infection on the day of surgical intervention
6. Radiographic evidence of peri-radicular pathology in impacted teeth requiring extraction

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 48 hours
measure: The maximum pain experienced by patients
timeFrame: 48 hours
Secondary outcomes:
measure: Onset of pain control
timeFrame: 48 hours
measure: Duration of pain control
timeFrame: 48 hours
measure: the rescue medicine intake
timeFrame: 48 hours
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: University dental Hospital
Study officials:
affiliation: University of Sharjah
name: Kamis Gaballah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Mehra P, Reebye U, Nadershah M, Cottrell D. Efficacy of anti-inflammatory drugs in third molar surgery: a randomized clinical trial. Int J Oral Maxillofac Surg. 2013 Jul;42(7):835-42. doi: 10.1016/j.ijom.2013.02.017. Epub 2013 Mar 25.
citation: Hersh EV, Pinto A, Moore PA. Adverse drug interactions involving common prescription and over-the-counter analgesic agents. Clin Ther. 2007;29 Suppl:2477-97. doi: 10.1016/j.clinthera.2007.12.003.
citation: Bailey E, Worthington H, Coulthard P. Ibuprofen and/or paracetamol (acetaminophen) for pain relief after surgical removal of lower wisdom teeth, a Cochrane systematic review. Br Dent J. 2014 Apr;216(8):451-5. doi: 10.1038/sj.bdj.2014.330.