Pain Control Following Third Molar Surgery

Pain Control Following Impacted Mandibular Third Molar Surgery: A Comparison of the Effectiveness of Two Different Protocols

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post Operative Pain; Impacted Third Molar Tooth
• Intervention / Treatment: Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours; Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United Arab Emirates
  • Sharjah, United Arab Emirates
    • University Dental Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study; 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	Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours; Group 1- The patient will receive 400mg ibuprofen plus 1000mg Paracetamol simultaneously every 8 hours for two days.
Active Comparator: Control; The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.	Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Pain was analyzed in 2 ways: (1) as the mean of pain intensity VAS score evaluated at 0, 4, 8, 12, 24, 36, and 48 hours post-extraction. Range 0-10	48 hours
The maximum pain experienced by patients	a)No pain, b)Some pain, c)Noticeable pain and d)Extreme pain	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset of pain control	The time to analgesic onset is defined as the time between trial drug intake and the first report of pain relief,	48 hours
Duration of pain control	the time between the first report of perceptible and meaningful pain relief and pain reappearing,	48 hours
the rescue medicine intake	the time from trial drug intake to the intake of the first dose of the rescue medicine	48 hours

Collaborators and Investigators

• Sponsor: University of Sharjah
• Investigators: Principal Investigator: Kamis Gaballah, PhD, University of Sharjah

Publications and helpful links

General Publications

• Colorado-Bonnin M, Valmaseda-Castellon E, Berini-Aytes L, Gay-Escoda C. Quality of life following lower third molar removal. Int J Oral Maxillofac Surg. 2006 Apr;35(4):343-7. doi: 10.1016/j.ijom.2005.08.008. Epub 2005 Nov 8.
• Friedman JW. The prophylactic extraction of third molars: a public health hazard. Am J Public Health. 2007 Sep;97(9):1554-9. doi: 10.2105/AJPH.2006.100271. Epub 2007 Jul 31.
• 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.
• Ogden GR, Bissias E, Ruta DA, Ogston S. Quality of life following third molar removal: a patient versus professional perspective. Br Dent J. 1998 Oct 24;185(8):407-10. doi: 10.1038/sj.bdj.4809827.
• Savin J, Ogden GR. Third molar surgery--a preliminary report on aspects affecting quality of life in the early postoperative period. Br J Oral Maxillofac Surg. 1997 Aug;35(4):246-53. doi: 10.1016/s0266-4356(97)90042-5.
• Kim K, Brar P, Jakubowski J, Kaltman S, Lopez E. The use of corticosteroids and nonsteroidal antiinflammatory medication for the management of pain and inflammation after third molar surgery: a review of the literature. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 May;107(5):630-40. doi: 10.1016/j.tripleo.2008.11.005. Epub 2009 Jan 20.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 21, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 21, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ibuprofen; Paracetamol; Third molar surgery; Post Operative Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Pain, Postoperative; Tooth, Impacted; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: REC-23-03-25-01-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD can not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No