Pain Control Following Third Molar Surgery

NCT ID: NCT06514222

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-09-30

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.

Conditions

Post Operative Pain; Impacted Third Molar Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours

Intervention Type: DRUG

Group 1- The patient will receive 400mg ibuprofen plus 1000mg Paracetamol simultaneously every 8 hours for two days.

Control

The patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days.

Group Type: ACTIVE_COMPARATOR

Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sharjah

OTHER

Sponsor Role: lead

Responsible Party

Kamis Gaballah

Program Director for MDS-Oral Surgery, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamis Gaballah, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sharjah

Locations

University dental Hospital

Sharjah city, , United Arab Emirates

Countries

United Arab Emirates

References

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Reference Type: BACKGROUND

PMID: 17666691 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16280233 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 9291262 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19157919 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 18164916 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24762895 (View on PubMed)

Gaballah K, Eldohaji T, Tannir ME, Shaban R, Habib R, Ali K. Pain control following impacted mandibular third molar surgery: a comparison of the effectiveness of two different protocols. Sci Rep. 2025 Apr 3;15(1):11519. doi: 10.1038/s41598-025-89744-0.

Reference Type: DERIVED

PMID: 40181005 (View on PubMed)

Other Identifiers

REC-23-03-25-01-S

Identifier Type: -

Identifier Source: org_study_id