Pain Control Following Third Molar Surgery

NCT06514222 | Active Not Recruiting Early Phase 1

• 1 other identifier: REC-23-03-25-01-S
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Impacted Third Molar Tooth

Keywords

Third molar surgery; Post Operative Pain; Paracetamol; Ibuprofen

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Onset of pain control

  48 hours

• Duration of pain control

  48 hours

• the rescue medicine intake

  48 hours

Study Arms (2)

study

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

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

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

study

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

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years,
• 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,
• ASA I-II status according to the American Society of Anesthesiologists, and
• No allergy to the drugs under study.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University dental Hospital

Sharjah city, United Arab Emirates

Location

Related Publications (9)

• 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.

  PMID: 17666691 BACKGROUND

• 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.

  PMID: 16280233 BACKGROUND

• 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.

  PMID: 9828502 BACKGROUND

• 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.

  PMID: 9291262 BACKGROUND

• 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.

  PMID: 19157919 BACKGROUND

• 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.

  PMID: 23535007 BACKGROUND

• 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.

  PMID: 18164916 BACKGROUND

• 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.

  PMID: 24762895 BACKGROUND

• 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.

  PMID: 40181005 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kamis Gaballah, PhD

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluators responsible for data collection and analyses are blinded to the analgesic medication regime used by the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director for MDS-Oral Surgery, Associate Professor

Model Details: A single-center, double-blind, parallel-group, randomized controlled clinical trial

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 23, 2024
• Study Start: July 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)