One pill for dental pain? researchers test a Two-Drug combo
NCT ID NCT03127592
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether a single pill combining etodolac, an anti-inflammatory painkiller, and cyclobenzaprine, a muscle relaxant, controls pain and swelling better than either drug taken alone. The trial enrolls about 140 healthy adults who have had an impacted wisdom tooth removed. Participants receive one of the three treatments, and researchers track pain scores and swelling over several days to compare how well each option works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a fixed-dose combination pill of etodolac, an anti-inflammatory painkiller, and cyclobenzaprine, a muscle relaxant
- What this could lead to
- If the combination works better than either drug alone, it could offer a single pill for stronger, more convenient relief after dental surgery.
- What could go wrong
- Combining two drugs can add side effects such as drowsiness, stomach upset, or dizziness, and the pair may not outperform each drug used separately. Results from one dental surgery setting may not apply to other types of pain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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140 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Jul 2022
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy research participants of both sexes (male and female non-pregnant), aged 18 years or over, underwent impacted third molar extraction surgery Exclusion Criteria: * Presence of any event and / or pathology at the site of interest that may interfere with and contraindicate the performance of the surgical procedure at the discretion of the Investigator, including periodontitis, odontogenic tumors or cysts (associated or not with the third molar), trauma, presence of Inflammation and / or infection; * Present or past history of any cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric, hematological event; * Previous diagnosis of alcohol and drug abuse defined by DSM-V; * Current or past history (for less than 12 months) of smoking; * Use of illicit drugs; * History of bleeding / bleeding or coagulation disorders, gastric ulcer and / or active peptic hemorrhage; * Any finding of clinical (clinical / physical), laboratory or cardiac evaluation (ECG) observation that is interpreted by the investigating physician as a risk to the participant; * Use of drugs that potentially interfere with the kinetics / dynamics of acetaminophen or any other medicinal product considered clinically significant by the Investigator; * Known hypersensitivity to the active principles used during the study (etodolac and cyclobenzaprine); * Women in gestation or breastfeeding, as well as women who present a positive pregnancy test (β - hCG) during the study screening / selection period; * Professionals directly involved in the realization of the present study and their relatives; * Participant of the research that has participated in clinical study protocols in the last 12 (twelve) months, unless the Investigator deems that there may be direct benefit to it.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
Valinhos, São Paulo, 13271-130, Brazil
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