Third Molars ExtractionEarly Phase 1NCT07108465
Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia
A Early Phase 1 study testing Bupivacaine 0,5% and Ropivacaine 0,75% in people with Third Molars Extraction, run by Henrique Tedesco at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to compare the efficacy of bupivacaine and ropivacaine in third molar removal surgery under general anesthesia in healthy volunteers. The main question aims to determine whether there is any difference in vital signs, hemostasis and postoperative pain between ropivacaine and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Third Molars Extraction
- What is being tested?
- Bupivacaine 0,5% and Ropivacaine 0,75%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18 to 60
- Patients ASA Physical Status Classification I and II
- Patients with impacted or semi-impacted lower third molars with similar positioning on both sides according to the Pell and Gregory classification
Who cannot join
- Patients who can have surgery under local anesthesia
- Patients where more procedures are required in the same surgical session
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90040-060
Henrique T Oliveira, 55 51999601939, htedesco99@gmail.com
About this study
The goal of this clinical trial is to compare the efficacy of bupivacaine and ropivacaine in third molar removal surgery under general anesthesia in healthy volunteers. The main question aims to determine whether there is any difference in vital signs, hemostasis and postoperative pain between ropivacaine and bupivacaine in patients undergoing third molars extraction under general anesthesia.
Researchers will compare bupivacaine and ropivacaine in a split-mouth study to determine if one drug is more effective in third molar extraction surgery under general anesthesia (better hemostasis, less postoperative pain, and fewer changes in vital signs). Participants will undergo a single surgical procedure and complete the Visual Analog Scale to record postoperative pain
- Conditions
- Third Molars Extraction
- Being tested
- Bupivacaine 0,5%, Ropivacaine 0,75%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0,5%Drug
Injection of bupivacaine 0,5% in group A
Ropivacaine 0,75%Drug
Injection of ropivacaine 0,75% in group B
| Study group | Role | What they receive |
|---|---|---|
| Group A - Bupivacaine | Active comparator | use of bupivacaine 0,5% + epinephrine 0,2mL in third molar surgery in general anesthesia Receives: Drug: Bupivacaine 0,5% |
| Group B - Ropivacaine | Active comparator | use of ropivacaine 0,75% + epinephrine 0,2mL in third molar surgery in general anesthesia Receives: Drug: Ropivacaine 0,75% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if there is a significant difference between groups in postoperative analgesic capacity using Visual Analog Scale, intraoperative hemostasis and in vital signs during anesthesia.
The Visual Analog Scale (0-10 VAS) can be interpreted as no pain (0), mild (1-3), moderate (4-6),severe (7-9),or worse pain (10)
Measured: From surgery to 7 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Third Molars ExtractionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrique Tedesco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrique Tedesco, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108465
- Sponsor's protocol ID
- 89726325.2.0000.5327
- Status last verified
- Apr 2026
- First submitted
- 22 Jul 2025
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalath RN, Kulal R, Gopinath S. Comparison of clinical efficacy of ropivacaine and lignocaine with adrenaline for implant surgery anesthesia: a split-mouth randomized controlled clinical trial. J Dent Anesth Pain Med. 2021 Aug;21(4):337-344. doi: 10.17245/jdapm.2021.21.4.337. Epub 2021 Jul 30.
PubMed 34395901
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Experimental Study Between Bupivacaine and Ropivacaine Regarding Efficacy in Third Molar Removal Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07108465
- Acronym / sponsor ID
- 89726325.2.0000.5327
- Conditions
- Third Molars Extraction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Henrique TedescoUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Aug 2025 (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 this clinical trial is to compare the efficacy of bupivacaine and ropivacaine in third molar removal surgery under general anesthesia in healthy volunteers. The main question aims to determine whether there is any difference in vital signs, hemostasis and postoperative pain between ropivacaine and bupivacaine in patients undergoing third molars extraction under general anesthesia.
Researchers will compare bupivacaine and ropivacaine in a split-mouth study to determine if one drug is more effective in third molar extraction surgery under general anesthesia (better hemostasis, less postoperative pain, and fewer changes in vital signs). Participants will undergo a single surgical procedure and complete the Visual Analog Scale to record postoperative pain
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Bupivacaine | Active comparator | Drug: Bupivacaine 0,5%use of bupivacaine 0,5% + epinephrine 0,2mL in third molar surgery in general anesthesia |
| Group B - Ropivacaine | Active comparator | Drug: Ropivacaine 0,75%use of ropivacaine 0,75% + epinephrine 0,2mL in third molar surgery in general anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 60
- Patients ASA Physical Status Classification I and II
- Patients with impacted or semi-impacted lower third molars with similar positioning on both sides according to the Pell and Gregory classification
Key exclusion criteria (2 listed)
- Patients who can have surgery under local anesthesia
- Patients where more procedures are required in the same surgical session
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 |
|---|---|---|
| Bupivacaine 0,5%Injection of bupivacaine 0,5% in group A | Drug | Group A - Bupivacaine |
| Ropivacaine 0,75%Injection of ropivacaine 0,75% in group B | Drug | Group B - Ropivacaine |
Primary outcome
Evaluate if there is a significant difference between groups in postoperative analgesic capacity using Visual Analog Scale, intraoperative hemostasis and in vital signs during anesthesia.
Time frame: From surgery to 7 postoperative days
The Visual Analog Scale (0-10 VAS) can be interpreted as no pain (0), mild (1-3), moderate (4-6),severe (7-9),or worse pain (10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 34395901Kalath RN, Kulal R, Gopinath S. Comparison of clinical efficacy of ropivacaine and lignocaine with adrenaline for implant surgery anesthesia: a split-mouth randomized controlled clinical trial. J Dent Anesth Pain Med. 2021 Aug;21(4):337-344. doi: 10.17245/jdapm.2021.21.4.337. Epub 2021 Jul 30.
- 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.
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 Bupivacaine 0,5% and Ropivacaine 0,75% in people with Third Molars Extraction, run by Henrique Tedesco at 1 site in Brazil.
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 2 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henrique T Oliveira (55 51999601939, htedesco99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate if there is a significant difference between groups in postoperative analgesic capacity using Visual Analog Scale, intraoperative hemostasis and in vital signs during anesthesia. (time frame: From surgery to 7 postoperative days). 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 NCT07108465, which also lists 1 linked publication.
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 1 May 2026.