Molar, ThirdNCT05923775
Pain and Trismus Control in Third Molar Surgery: Ibuprofen, Ketamine, and Their Combination
A study testing Impacted third molar surgey in people with Molar, Third, run by Cihan Topan at 1 site in Turkey (Türkiye).
Trial summary
The goal of the clinical trial is to compare the efficacy of ibuprofen, ketamine, and their combination in managing postoperative pain and trismus following third molar surgery. The main question it aims to answer is: which is the best way to control pain and trismus after third molar surgery? Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Molar, Third
- What is being tested?
- Impacted third molar surgey
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 15 Sep 2023
- Phase
- Interventional
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a fully embedded third molar tooth in the mandible
- Patients with regular attendance for routine follow up
- Patients with a healthy general systemic condition
Who cannot join
- Patients with a fully erupted or partially embedded third molar tooth in the mandible
- Patients who have previously experienced allergies to NSAIDs, local anesthetics, and ketamine
- Pregnant or breastfeeding patients
- Patients who have recently used a different group of NSAIDs for a different condition
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Faculty of Dentistry
Kayseri, (0352) 438 06 57
Cihan Topan, Doctor, 05556456587, cihantopan@hotmail.com
About this study
Official title: Comparative Effectiveness of Preemptive Ibuprofen, Ketamine, and Their Combination in Postoperative Pain and Trismus Management Following Third Molar Surgery
The goal of the clinical trial is to compare the efficacy of ibuprofen, ketamine, and their combination in managing postoperative pain and trismus following third molar surgery. The main question it aims to answer is: which is the best way to control pain and trismus after third molar surgery?
Read the detailed description
Materials and methods The study will comprise 100 individuals who requested to have their mandibular third molar tooth extracted at the Erciyes University Faculty of Dentistry. Participants were randomly allocated into four groups, with 25 patients in each group.
The first group (Intrafen group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.
The second group (Ketamine group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed.
The third group (Combined group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed.
The fourth group (Control group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.
- Conditions
- Molar, Third
- Being tested
- Impacted third molar surgey
- Keywords
- pain, trismus, analgesia, ketamine, Ibuprofen
- Medical subject headings
- Pain, Trismus, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacted third molar surgeyProcedure or surgery
The surgery was performed using the classic technique: ten minutes after anesthesia administration, a horizontal and sulcular incision was performed, and a mucoperiosteal envelope flap was elevated. The bone covering the impacted third molar tooth was removed with the use of a surgical handpiece and rotary instrument. During the operation, saline water was applied to the surgical drill with a second hand to protect the bone from developing a high temperature. After extraction of the third molar, the cavity was treated with curettage, irrigated with saline, and sutured.
| Study group | Role | What they receive |
|---|---|---|
| Intrafen group | Active comparator | Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia. Receives: Procedure: Impacted third molar surgey |
| Ketamine group | Active comparator | Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia. Receives: Procedure: Impacted third molar surgey |
| Combined group (Intrafen+Ketamine) | Active comparator | Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the surgery, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia. Receives: Procedure: Impacted third molar surgey |
| Control | Placebo comparator | Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia. Receives: Procedure: Impacted third molar surgey |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Measured: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) two hours following impacted third molar surgery. [All study participants were asked to record their pain levels two hours after surgery].
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Measured: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) six hours following impacted third molar surgery. [All study participants were asked to record their pain levels six hours after surgery].
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Measured: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 12 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 12 hours after surgery].
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
Measured: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 24 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 24 hours after surgery].
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups.
Trismus was evaluated preoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
Measured: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded before surgery].
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Trismus was evaluated on the second day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
Measured: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded two days after the surgery].
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Trismus was evaluated on the seventh day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
Measured: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded seven days after the surgery].
Secondary outcomes (1)
The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.
All study participants will record the dose of rescue analgesic medicine (Paracetamol 500 mg) at home if they need to take it within 24 hours following surgery.
Measured: The mean amount of rescue analgesia used by all participants within the first 24 hours after surgery will be calculated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Mar 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar, ThirdStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cihan Topan
- Sponsor type
- University, hospital or other
- Collaborators
- TC Erciyes University
- Responsible party
- Sponsor-investigator, Cihan Topan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923775
- Sponsor's protocol ID
- 2021/197
- Status last verified
- Sep 2023
- First submitted
- 16 Jun 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Preemptive Ibuprofen, Ketamine, and Their Combination in Postoperative Pain and Trismus Management Following Third Molar Surgery
- ClinicalTrials.gov ID
- NCT05923775
- Acronym / sponsor ID
- 2021/197
- Conditions
- Molar, Third
- Keywords
- pain, trismus, analgesia, ketamine, Ibuprofen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cihan TopanUniversity, hospital or other
- Collaborators
- TC Erciyes University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 28 Jun 2023 (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.
The goal of the clinical trial is to compare the efficacy of ibuprofen, ketamine, and their combination in managing postoperative pain and trismus following third molar surgery. The main question it aims to answer is: which is the best way to control pain and trismus after third molar surgery?
Detailed description
Materials and methods The study will comprise 100 individuals who requested to have their mandibular third molar tooth extracted at the Erciyes University Faculty of Dentistry. Participants were randomly allocated into four groups, with 25 patients in each group.
The first group (Intrafen group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.
The second group (Ketamine group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed.
The third group (Combined group): Each patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution) plus 0,3 mg/kg of ketamine (Ketalar 500 mg). The impacted third molars of the patients will be removed.
The fourth group (Control group): Each patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, patients will be given local anesthesia using a mixture of 2 ml of local anesthetic (Ultracain Ds Fort 2 ml) plus 3 ml of saline solution (Poliflex 0.9% isotonic 100 ml solution). The impacted third molars of the patients will be removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intrafen group | Active comparator | Procedure: Impacted third molar surgeyEach patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia. |
| Ketamine group | Active comparator | Procedure: Impacted third molar surgeyEach patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia. |
| Combined group (Intrafen+Ketamine) | Active comparator | Procedure: Impacted third molar surgeyEach patient in this group will be administered intravenous Ibuprofen (400 mg/8 ml i.v. infusion) for pre-emptive analgesic effect 60 minutes before surgical third molar extraction. Before the surgery, each patient in this group will be given 0.3 mg/kg of ketamine (Ketalar 500 mg) in addition to 2 ml of local anesthesia. |
| Control | Placebo comparator | Procedure: Impacted third molar surgeyEach patient in this group will be administered intravenous 100 ml saline (Poliflex 0.9% isotonic 100 ml solution) for a placebo effect 60 minutes before surgical third molar extraction. Before the procedure, each patient in this group will be given 2 ml of local anesthesia. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with a fully embedded third molar tooth in the mandible
- Patients with regular attendance for routine follow up
- Patients with a healthy general systemic condition
Key exclusion criteria (4 listed)
- Patients with a fully erupted or partially embedded third molar tooth in the mandible
- Patients who have previously experienced allergies to NSAIDs, local anesthetics, and ketamine
- Pregnant or breastfeeding patients
- Patients who have recently used a different group of NSAIDs for a different condition
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 |
|---|---|---|
| Impacted third molar surgeyThe surgery was performed using the classic technique: ten minutes after anesthesia administration, a horizontal and sulcular incision was performed, and a mucoperiosteal envelope flap was elevated. The bone covering the impacted third molar tooth was removed with the use of a surgical handpiece and rotary instrument. During the operation, saline water was applied to the surgical drill with a second hand to protect the bone from developing a high temperature. After extraction of the third molar, the cavity was treated with curettage, irrigated with saline, and sutured. | Procedure or surgery | Combined group (Intrafen+Ketamine), Control, Intrafen group, Ketamine group |
Primary outcome
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Time frame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) two hours following impacted third molar surgery. [All study participants were asked to record their pain levels two hours after surgery].
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Time frame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) six hours following impacted third molar surgery. [All study participants were asked to record their pain levels six hours after surgery].
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Time frame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 12 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 12 hours after surgery].
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups.
Time frame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) 24 hours following impacted third molar surgery. [All study participants were asked to record their pain levels 24 hours after surgery].
VAS (Pain intensity was assessed on a 100-mm visual analoge scale, where 0=no pain and 100=worst possible pain)
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups.
Time frame: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded before surgery].
Trismus was evaluated preoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Time frame: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded two days after the surgery].
Trismus was evaluated on the second day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups
Time frame: The limitation of mouth opening (trismus) after third molar surgery will be measured in all groups. [The maximum mouth opening of all study participants will be measured and recorded seven days after the surgery].
Trismus was evaluated on the seventh day postoperatively by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at the maximum opening of the jaws.
1 secondary outcome
The secondary outcome measure is the amount of rescue analgesia used by all participants after impacted third molar tooth surgery.
Time frame: The mean amount of rescue analgesia used by all participants within the first 24 hours after surgery will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impacted third molar surgey in people with Molar, Third, run by Cihan Topan at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 7 Sep 2023. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Cihan Topan, Doctor (05556456587, cihantopan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pain level measurement after impacted third molar surgery will be assessed with the visual analog scale (VAS) in all groups. (time frame: The pain level measurements of all patients will be evaluated by a visual analog scale (VAS) two hours following impacted third molar surgery. [All study participants were asked to record their pain levels two hours after surgery].). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2023.