Post Operative PainEarly Phase 1NCT06514222
Pain Control Following Third Molar Surgery
A Early Phase 1 study testing Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours and Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours in people with Post Operative Pain and Impacted Third Molar Tooth, run by University of Sharjah at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post Operative Pain, Impacted Third Molar Tooth
- What is being tested?
- Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours and Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jul 2024to 30 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
University dental Hospital
Sharjah city
About this study
Official title: 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.
Read the 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
- Being tested
- Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours, Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours
- Keywords
- Third molar surgery, Post Operative Pain, Paracetamol, Ibuprofen
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hoursDrug
Group 1- The patient will receive 400mg ibuprofen plus 1000mg Paracetamol simultaneously every 8 hours for two days.
Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hoursDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
The maximum pain experienced by patients
a)No pain, b)Some pain, c)Noticeable pain and d)Extreme pain
Measured: 48 hours
Secondary outcomes (3)
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,
Measured: 48 hours
Duration of pain control
the time between the first report of perceptible and meaningful pain relief and pain reappearing,
Measured: 48 hours
the rescue medicine intake
the time from trial drug intake to the intake of the first dose of the rescue medicine
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jul 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, double-blind, parallel-group, randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamis Gaballah, University of Sharjah
- Investigators
- Kamis Gaballah, PhD, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514222
- Sponsor's protocol ID
- REC-23-03-25-01-S
- Status last verified
- Jul 2024
- First submitted
- 8 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD can not be shared
Publications
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.
PubMed 17666691Colorado-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.
PubMed 16280233Ogden 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.
PubMed 9828502Savin 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.
PubMed 9291262Kim 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.
PubMed 19157919Mehra 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.
PubMed 23535007Hersh 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.
PubMed 18164916Bailey 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.
PubMed 24762895Gaballah 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.
PubMed 40181005
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control Following Impacted Mandibular Third Molar Surgery: A Comparison of the Effectiveness of Two Different Protocols
- ClinicalTrials.gov ID
- NCT06514222
- Acronym / sponsor ID
- REC-23-03-25-01-S
- Conditions
- Post Operative Pain, Impacted Third Molar Tooth
- Keywords
- Third molar surgery, Post Operative Pain, Paracetamol, Ibuprofen
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, double-blind, parallel-group, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hourspatient 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 | Active comparator | Drug: Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hoursThe patient will receive 400mg of ibuprofen plus 1000mg of Paracetamol simultaneously every 8 hours for two days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hoursGroup 1- The patient will receive 400mg ibuprofen plus 1000mg Paracetamol simultaneously every 8 hours for two days. | Drug | study |
| Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hoursGroup 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 | Drug | Control |
Primary outcome
Visual Analogue Scale
Time frame: 48 hours
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
The maximum pain experienced by patients
Time frame: 48 hours
a)No pain, b)Some pain, c)Noticeable pain and d)Extreme pain
3 secondary outcomes
Onset of pain control
Time frame: 48 hours
Duration of pain control
Time frame: 48 hours
the rescue medicine intake
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 17666691Friedman 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.
- Background: PubMed 16280233Colorado-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.
- Background: PubMed 9828502Ogden 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.
- Background: PubMed 9291262Savin 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.
- Background: PubMed 19157919Kim 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.
- Background: PubMed 23535007Mehra 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.
- Background: PubMed 18164916Hersh 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.
- Background: PubMed 24762895Bailey 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.
- Derived from this study: PubMed 40181005Gaballah 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.
- Individual participant dataSharing planned: No. The IPD can not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamis Gaballah, PhD principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given together every 8 hours and Paracetamol and Ibuprofen. The combination of the Paracetamol and Ibuprofen will be given alternatively every four hours in people with Post Operative Pain and Impacted Third Molar Tooth, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06514222, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.