Impacted Third Molar ToothNCT06318013
Perineural and Systemic Dexamethasone Use in Dental Surgeries in Terms of Anesthesia Duration and Postop Complaints
An observational study of Impacted Third Molar Tooth, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- vitality test
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2024to 26 May 2024
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy, male and female patients between the ages of 18-35
Who may be able to join
- ASA class 1, impacted teeth in Class II position B according to the Pell and Gregory classification, with no signs of inflammation and no dental pathology
Who cannot join
- Pregnant or breastfeeding women, patients with diabetes, endocrine disease, hypertension patients, patients with bleeding disorders or using anticoagulants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry
Karaman, 70100
About this study
Official title: Comparison of Perineural and Systemic Dexamethasone Use in Third Molar Dental Surgeries in Terms of Anesthesia Duration and Postoperative Complaints: a Controlled, Randomized Observational Study.
Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use.
Read the detailed description
PURPOSE OF THE RESEARCH: Third molar tooth extraction is a frequently performed procedure in dentistry. Depending on the degree of impaction of the teeth, this procedure causes postoperative sequelae such as pain and edema that reduce the quality of life. Clinical studies have proven that the use of antibiotics, physiotherapy, corticosteroid treatment, and antiseptic mouthwashes reduce postoperative complications.
There are different ways to use costosteroids in dental practice. Intravenous, intramuscular, perineural and oral tablet administration are the most preferred. It has been proven that if dexamethasone is given systemically, the duration of anesthesia in shoulder surgeries is prolonged and post-operative pain is less. (1) However, no study evaluating this parameter regarding twenty-year-old surgeries has been found in the literature. The aim of this study is to compare the post-procedure numbness duration and postoperative sequelae in patients who were administered dexamethasone intravenously and perineurally perioperatively.
Material Method: The study is planned to be carried out at Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry. Patients who apply to the Oral and Maxillofacial Surgery Department for impacted wisdom tooth extraction and are directed to the local intervention room for tooth extraction will be asked whether they want to participate in the study after leaving the procedure room. Patients who want to participate in the study will have an informed consent form read and their signature will be taken if they declare that they want to participate in the study. Patients participating in the study will be checked for drowsiness every 30 minutes for the first 2 hours after the procedure, and every 15 minutes from the 3rd hour onwards. Drowsiness control will be done with a device called vitalometer that measures the vitality of teeth. The start time of the operation and the time the numbness subsides will be recorded. On the 1st, 3rd and 7th days following the operation, tragus-pogonion, tragus-mouth canthus and gonion-lateral canthus will be measured to evaluate swelling. Measurement will be made with a tape measure. Additionally, pain assessment and maximum mouth opening measurement will be performed with a visual analog scale on the same days. Manual caliper will be used for mouth opening measurement.
The inclusion criteria for the study were patients between the ages of 18 and 35, with ASA class 1, impacted teeth in Class II position B according to the Pell and Gregory classification, and without signs of inflammation and dental pathology. Pregnant or breastfeeding women, patients with diabetes, endocrine diseases, hypertension patients, bleeding disorders or patients using anticoagulants will be excluded from the study. If the duration of the surgical procedure is more than 30 minutes, if repeated doses of local anesthetic are injected during the procedure, and if surgical complications occur during the procedure, patients will be excluded from the study. This information will be checked from the epicrisis report filled out by the physician performing the operation.
Three groups will be formed by examining the procedures applied to the patients and the medications given to them from the patient follow-up program of the faculty of dentistry. It is planned to include 20 patients in each group. These are those who were administered perineural dexamethasone, those who were administered intravenous dexamethasone, and those who were not administered dexamethasone (control). The results obtained from the measurements will be compared in these 3 groups.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- vitality test
- Keywords
- Impacted third molar, Dexamethasone, anesthesia duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitality testDiagnostic test
A vitality test will be performed using a vitalometer to check if the drowsiness is gone
| Study group | Role | What they receive |
|---|---|---|
| Control | Group receiving only local anesthesia Receives: Diagnostic Test: vitality test | |
| Intravenous Dexamethasone | Group using dexamethasone IV Receives: Diagnostic Test: vitality test | |
| Perineural Dexamethasone | group administered perineural dexamethasone Receives: Diagnostic Test: vitality test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swelling
In order to determine the course of postoperative edema in patients with tooth extraction, tragus-pogonion (S1), tragus-mouth canthus (S2) and gonion-lateral canthus (S3) will be measured with the help of a tape measure.
Measured: 1 week
Duration of anesthesia
After anesthesia, the time it takes for numbness to subside will be measured in minutes. A vitalometer device will be used to check that anesthesia has passed.
Measured: 6 hours
Secondary outcomes (1)
Pain Score
Vas scale (no pain:0-intolerable pain:10) will be used to measure postoperative pain in patients with tooth extraction.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start27 Mar 2024
- Primary completion15 Apr 2024
- Study completion26 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dogan Ilgaz Kaya, Karamanoğlu Mehmetbey University
- Investigators
- Ahmet Aktı, Dr, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318013
- Sponsor's protocol ID
- 2022-KAEK-15427-04-204-2022101
- Status last verified
- May 2024
- First submitted
- 12 Mar 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not need to record participants' personal data for this study.
Publications
Ruthvik S, Krishnan M, George M, Kumar SP, Lakshmanan S. Efficacy of Dexamethasone Diluted Saline Irrigant on Postoperative Sequelae in Patients Undergoing Lower Third Molar Surgery: A Prospective Clinical Study. Cureus. 2023 Sep 18;15(9):e45436. doi: 10.7759/cureus.45436. eCollection 2023 Sep.
PubMed 37859912Poorna P, Shetty P, Kalyani V, Shetty S, Upadya M, Mithra P. A comparative evaluation of the effect of addition of 8 mg dexamethasone to 2% lignocaine with adrenaline in mandibular third molar surgery: a split mouth randomised double blind study. Front Oral Health. 2024 Feb 9;5:1349832. doi: 10.3389/froh.2024.1349832. eCollection 2024.
PubMed 38404531Priyanga R, Balamurugan R, Rajan PS. Comparison of dexamethasone administration through sublingual and intramuscular routes for evaluation of pain, swelling, and trismus after impacted mandibular third molar surgery-a prospective randomized controlled study. Oral Maxillofac Surg. 2022 Mar;26(1):155-159. doi: 10.1007/s10006-021-00978-4. Epub 2021 Jun 5.
PubMed 34091813Kaya DI, Akti A. Comparison of perineural and systemic dexamethasone use in impacted third molar surgeries in terms of anesthesia duration and postoperative complaints: a controlled, randomized observational study. BMC Oral Health. 2024 Jun 18;24(1):706. doi: 10.1186/s12903-024-04483-4.
PubMed 38890655
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perineural and Systemic Dexamethasone Use in Third Molar Dental Surgeries in Terms of Anesthesia Duration and Postoperative Complaints: a Controlled, Randomized Observational Study.
- ClinicalTrials.gov ID
- NCT06318013
- Acronym / sponsor ID
- 2022-KAEK-15427-04-204-2022101
- Conditions
- Impacted Third Molar Tooth
- Keywords
- Impacted third molar, Dexamethasone, anesthesia duration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 26 May 2024 (actual)
- First posted
- 19 Mar 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.
Participants will be asked to use some medications after the tooth extraction procedure. These drugs can be used in different ways. Investigators plan to monitor the pain, swelling and duration of anesthesia in the body as a result of participants use.
Detailed description
PURPOSE OF THE RESEARCH: Third molar tooth extraction is a frequently performed procedure in dentistry. Depending on the degree of impaction of the teeth, this procedure causes postoperative sequelae such as pain and edema that reduce the quality of life. Clinical studies have proven that the use of antibiotics, physiotherapy, corticosteroid treatment, and antiseptic mouthwashes reduce postoperative complications.
There are different ways to use costosteroids in dental practice. Intravenous, intramuscular, perineural and oral tablet administration are the most preferred. It has been proven that if dexamethasone is given systemically, the duration of anesthesia in shoulder surgeries is prolonged and post-operative pain is less. (1) However, no study evaluating this parameter regarding twenty-year-old surgeries has been found in the literature. The aim of this study is to compare the post-procedure numbness duration and postoperative sequelae in patients who were administered dexamethasone intravenously and perineurally perioperatively.
Material Method: The study is planned to be carried out at Karamanoğlu Mehmetbey University Ahmet Keleşoğlu Faculty of Dentistry. Patients who apply to the Oral and Maxillofacial Surgery Department for impacted wisdom tooth extraction and are directed to the local intervention room for tooth extraction will be asked whether they want to participate in the study after leaving the procedure room. Patients who want to participate in the study will have an informed consent form read and their signature will be taken if they declare that they want to participate in the study. Patients participating in the study will be checked for drowsiness every 30 minutes for the first 2 hours after the procedure, and every 15 minutes from the 3rd hour onwards. Drowsiness control will be done with a device called vitalometer that measures the vitality of teeth. The start time of the operation and the time the numbness subsides will be recorded. On the 1st, 3rd and 7th days following the operation, tragus-pogonion, tragus-mouth canthus and gonion-lateral canthus will be measured to evaluate swelling. Measurement will be made with a tape measure. Additionally, pain assessment and maximum mouth opening measurement will be performed with a visual analog scale on the same days. Manual caliper will be used for mouth opening measurement.
The inclusion criteria for the study were patients between the ages of 18 and 35, with ASA class 1, impacted teeth in Class II position B according to the Pell and Gregory classification, and without signs of inflammation and dental pathology. Pregnant or breastfeeding women, patients with diabetes, endocrine diseases, hypertension patients, bleeding disorders or patients using anticoagulants will be excluded from the study. If the duration of the surgical procedure is more than 30 minutes, if repeated doses of local anesthetic are injected during the procedure, and if surgical complications occur during the procedure, patients will be excluded from the study. This information will be checked from the epicrisis report filled out by the physician performing the operation.
Three groups will be formed by examining the procedures applied to the patients and the medications given to them from the patient follow-up program of the faculty of dentistry. It is planned to include 20 patients in each group. These are those who were administered perineural dexamethasone, those who were administered intravenous dexamethasone, and those who were not administered dexamethasone (control). The results obtained from the measurements will be compared in these 3 groups.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: vitality testGroup receiving only local anesthesia |
| Intravenous Dexamethasone | – | Diagnostic Test: vitality testGroup using dexamethasone IV |
| Perineural Dexamethasone | – | Diagnostic Test: vitality testgroup administered perineural dexamethasone |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, male and female patients between the ages of 18-35
Key inclusion criteria (1 listed)
- ASA class 1, impacted teeth in Class II position B according to the Pell and Gregory classification, with no signs of inflammation and no dental pathology
Key exclusion criteria (1 listed)
- Pregnant or breastfeeding women, patients with diabetes, endocrine disease, hypertension patients, patients with bleeding disorders or using anticoagulants
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 |
|---|---|---|
| vitality testA vitality test will be performed using a vitalometer to check if the drowsiness is gone | Diagnostic test | Control, Intravenous Dexamethasone, Perineural Dexamethasone |
Primary outcome
Swelling
Time frame: 1 week
In order to determine the course of postoperative edema in patients with tooth extraction, tragus-pogonion (S1), tragus-mouth canthus (S2) and gonion-lateral canthus (S3) will be measured with the help of a tape measure.
Duration of anesthesia
Time frame: 6 hours
After anesthesia, the time it takes for numbness to subside will be measured in minutes. A vitalometer device will be used to check that anesthesia has passed.
1 secondary outcome
Pain Score
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Results publication: PubMed 37859912Ruthvik S, Krishnan M, George M, Kumar SP, Lakshmanan S. Efficacy of Dexamethasone Diluted Saline Irrigant on Postoperative Sequelae in Patients Undergoing Lower Third Molar Surgery: A Prospective Clinical Study. Cureus. 2023 Sep 18;15(9):e45436. doi: 10.7759/cureus.45436. eCollection 2023 Sep.
- Results publication: PubMed 38404531Poorna P, Shetty P, Kalyani V, Shetty S, Upadya M, Mithra P. A comparative evaluation of the effect of addition of 8 mg dexamethasone to 2% lignocaine with adrenaline in mandibular third molar surgery: a split mouth randomised double blind study. Front Oral Health. 2024 Feb 9;5:1349832. doi: 10.3389/froh.2024.1349832. eCollection 2024.
- Results publication: PubMed 34091813Priyanga R, Balamurugan R, Rajan PS. Comparison of dexamethasone administration through sublingual and intramuscular routes for evaluation of pain, swelling, and trismus after impacted mandibular third molar surgery-a prospective randomized controlled study. Oral Maxillofac Surg. 2022 Mar;26(1):155-159. doi: 10.1007/s10006-021-00978-4. Epub 2021 Jun 5.
- Derived from this study: PubMed 38890655Kaya DI, Akti A. Comparison of perineural and systemic dexamethasone use in impacted third molar surgeries in terms of anesthesia duration and postoperative complaints: a controlled, randomized observational study. BMC Oral Health. 2024 Jun 18;24(1):706. doi: 10.1186/s12903-024-04483-4.
- Individual participant dataSharing planned: No. We do not need to record participants' personal data for this study.
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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.
Ahmet Aktı, Dr principal investigator
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Third Molar Tooth, run by Karamanoğlu Mehmetbey University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 May 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Swelling (time frame: 1 week). 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 NCT06318013, which also lists 4 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 31 May 2024.