Impacted Third Molar ToothPhase 4NCT05268835
Different Oral Doses of Clindamycin in Preventing Post-operative Sequelae of Lower Third Molar Surgery
A Phase 4 study testing Dalacin C in people with Impacted Third Molar Tooth and Impacted Molar, run by Oral and Maxillofacial Surgery Clinic, Poland at 1 site in Poland.
Trial summary
The objective of the study is to determine the effect of antibiotic prophylaxis with three different doses of clindamycin on preventing infection and other complications after surgical extraction of impacted mandibular third molars. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth, Impacted Molar
- What is being tested?
- Dalacin C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2020to Oct 2022
- Phase
- Phase 4
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Child-bearing potential or non-child-bearing potential female or male, non-smoker, ≥ 18 and ≤65 years of age at the time of signing the informed consent, weighing >50kg.
- Non-child-bearing potential female subject is defined as follows:
- Post-menopausal state: absence of menses for 12 months prior to drug administration or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration.
- Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
- Capable of consent.
- Patient scheduled to undergo the removal of bony impacted mandibular molar under short-acting local anesthetic (e.g. mepivacaine, articaine or lidocaine) preoperatively
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- Patient who has signed a written informed consent obtained prior to any study-related procedures
- Patient able to understand and comply with protocol requirements and instructions
- Female patient of childbearing potential must be willing to use a highly efficient birth control method during the study
Who cannot join
- Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during the medical screening.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Positive testing for hepatitis B, hepatitis C, or HIV at screening.
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- Electrocardiographic abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
- BMI≥ 30.0kg/m2.
- History of significant alcohol abuse within six months prior to the screening visit or any indication of the regular use of more than fourteen units of alcohol per week or positive alcohol breath test at screening. History of drug abuse or use of illegal drugs. Alcohol abuse is defined as the consumption of more than 90ml of liquor or spirits or 530ml of beer per day, for consecutive days during the 6-months period. Drug abuse is defined as any recreational drug for 5 consecutive days during the 6-month period.
- Patient with any known hypersensitivity to clindamycin or other related drugs (e.g., lincomycin), paracetamol or ibuprofen; having developed hypersensitivity reactions, including symptoms of asthma, rhinitis, angioedema or urticaria.
- History of allergic reactions to heparin.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, monoamine oxidase inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
- Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Patient with a current or chronic history of severe renal impairment
- Patient with severe heart failure (New York Heart Association (NHYA) Class IV)
- Patient with history of gastrointestinal bleeding or perforation, related to previous antibiotics or NSAIDs therapy; gastrointestinal haemorrhage, cerebrovascular haemorrhage or of other evolving haemorrhage; an active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
- Patient with inflammation or ulcerative disease of the oral mucosa
- Patient with known systemic lupus erythematosus
- Patient who undergoes an extraction of contralateral molar in the same procedure or a bony-impacted molar
- Patient treated by antibiotics, analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within the 3 days prior to the day of randomization (or within 5 times the elimination half-life whichever the longest)
- Patient who received other antibiotics or analgesic than short-acting preoperative or intraoperative local anesthetic agents within 12 hours before the start of the surgery or peri-operatively until randomization
- Women with positive results on a urine pregnancy test or breastfeeding women or women of childbearing potential without an effective contraception
- Patient having any current dental or medical condition that could prevent safe participation in this study
- Unwillingness or inability to follow the procedures outlined in the protocol
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Difficulty to swallow study medication.
- Use of any tobacco products in the 90 days preceding drug administration.
- Any food allergy, intolerance, restriction or special diet that could, in the opinion of the Investigator, contraindicate the subjects' participation in this study.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication.
- Subjects with a clinically significant history of tuberculosis, epilepsy, asthma, diabetes, psychosis, or glaucoma will not be eligible for this study.
- Clinically significant history of diarrhea subsequent to administration of antibacterial agents or antibiotics.
- Additional exclusion criteria for females only:
- Breast-feeding subject.
- Positive urine pregnancy test at screening
- Female subjects of childbearing potential having unprotected sexual intercourse with any non-sterile male partner (i.e., male who has not been sterilized by vasectomy for at least 6 months) within 14 says prior to study drug administration. Acceptable methods of contraception:
- condom + spermicide,
- diaphragm + spermicide,
- intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
OMFS Clinic
Zgierz, 95-100
Anna Janas-Naze, DMD,PhD,Prof, 7164485 ext. 004842, anna.janas.naze@gmail.com
Anna Janas-Naze, DMD,PhD,Prof
About this study
Official title: Comparative Efficacy of Different Oral Doses of Clindamycin in Preventing Post-operative Sequelae of Lower Third Molar Surgery - a Randomized, Triple-blind Study
The objective of the study is to determine the effect of antibiotic prophylaxis with three different doses of clindamycin on preventing infection and other complications after surgical extraction of impacted mandibular third molars.
Read the detailed description
The objective of the study is to determine the effect of antibiotic prophylaxis with three different doses of clindamycin on preventing infection and other complications after surgical extraction of impacted mandibular third molars.
A randomized, triple blind, controlled clinical trial is conducted, in Oral and Maxillofacial Surgery Clinic. Patients were randomly allocated to three groups: I - receiving 150mg of clindamycin after surgery every 8 hours, II - receiving 300mg of clindamycin after surgery every 8 hours and III - receiving 600mg of clindamycin after surgery every 12 hours. Each group continued the therapy for five days. The investigators anticipate the overall decrease in risk of infection and other postoperative complications, however whether the differences between the clindamycin concentrations, occurrence of postoperative sequelae and pain in the three groups are statistically significant, remains to be seen.
- Conditions
- Impacted Third Molar Tooth, Impacted Molar
- Being tested
- Dalacin C
- Keywords
- impacted third molars, post operative pain, trismus, infection
- Medical subject headings
- Pain, Postoperative, Trismus, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalacin CDrug
The objective of the intervention is to determine the effect of antibiotic prophylaxis with three different doses of clindamycin on preventing infection and other complications after surgical extraction of impacted mandibular third molars
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin 150mg | Active comparator | Patients receiving 150mg of clindamycin (Dalacin C, Pfizer) after surgery every 8 hours Receives: Drug: Dalacin C |
| Clindamycin 300mg | Active comparator | Patients receiving 300mg of clindamycin after surgery every 8 hours Receives: Drug: Dalacin C |
| Clindamycin 600mg | Active comparator | Patients receiving 600mg of clindamycin after surgery every 12 hours Receives: Drug: Dalacin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Measured: Baseline - 60 minutes after administration
Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Measured: 24 hours after surgery
Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Measured: 48 hours after surgery
Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 Feb 2020
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oral and Maxillofacial Surgery Clinic, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Janas-Naze, DMD,PhD,Prof, Principal investigator, OMFS Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268835
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If the results are published, the data will be stored at repository with doi.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Different Oral Doses of Clindamycin in Preventing Post-operative Sequelae of Lower Third Molar Surgery - a Randomized, Triple-blind Study
- ClinicalTrials.gov ID
- NCT05268835
- Acronym / sponsor ID
- 001
- Conditions
- Impacted Third Molar Tooth, Impacted Molar
- Keywords
- impacted third molars, post operative pain, trismus, infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oral and Maxillofacial Surgery Clinic, PolandUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 7 Mar 2022 (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 objective of the study is to determine the effect of antibiotic prophylaxis with three different doses of clindamycin on preventing infection and other complications after surgical extraction of impacted mandibular third molars.
Detailed description
The objective of the study is to determine the effect of antibiotic prophylaxis with three different doses of clindamycin on preventing infection and other complications after surgical extraction of impacted mandibular third molars.
A randomized, triple blind, controlled clinical trial is conducted, in Oral and Maxillofacial Surgery Clinic. Patients were randomly allocated to three groups: I - receiving 150mg of clindamycin after surgery every 8 hours, II - receiving 300mg of clindamycin after surgery every 8 hours and III - receiving 600mg of clindamycin after surgery every 12 hours. Each group continued the therapy for five days. The investigators anticipate the overall decrease in risk of infection and other postoperative complications, however whether the differences between the clindamycin concentrations, occurrence of postoperative sequelae and pain in the three groups are statistically significant, remains to be seen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clindamycin 150mg | Active comparator | Drug: Dalacin CPatients receiving 150mg of clindamycin (Dalacin C, Pfizer) after surgery every 8 hours |
| Clindamycin 300mg | Active comparator | Drug: Dalacin CPatients receiving 300mg of clindamycin after surgery every 8 hours |
| Clindamycin 600mg | Active comparator | Drug: Dalacin CPatients receiving 600mg of clindamycin after surgery every 12 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Child-bearing potential or non-child-bearing potential female or male, non-smoker, ≥ 18 and ≤65 years of age at the time of signing the informed consent, weighing >50kg.
- Non-child-bearing potential female subject is defined as follows:
- Capable of consent.
- Patient scheduled to undergo the removal of bony impacted mandibular molar under short-acting local anesthetic (e.g. mepivacaine, articaine or lidocaine) preoperatively
- Patient who has signed a written informed consent obtained prior to any study-related procedures
Key exclusion criteria (38 listed)
- Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during the medical screening.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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 |
|---|---|---|
| Dalacin CThe objective of the intervention is to determine the effect of antibiotic prophylaxis with three different doses of clindamycin on preventing infection and other complications after surgical extraction of impacted mandibular third molars | Drug | Clindamycin 150mg, Clindamycin 300mg, Clindamycin 600mg |
Primary outcome
Post-surgical infectious complications.
Time frame: Baseline - 60 minutes after administration
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Post-surgical infectious complications.
Time frame: 24 hours after surgery
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Post-surgical infectious complications.
Time frame: 48 hours after surgery
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Post-surgical infectious complications.
Time frame: 7 days after surgery
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: Yes. If the results are published, the data will be stored at repository with doi.
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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.
Anna Janas-Naze, DMD,PhD,Prof principal investigator
OMFS Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalacin C in people with Impacted Third Molar Tooth and Impacted Molar, run by Oral and Maxillofacial Surgery Clinic, Poland at 1 site in Poland.
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 9 inclusion and 38 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 Mar 2022. 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 Poland. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Anna Janas-Naze, DMD,PhD,Prof (7164485 ext. 004842, anna.janas.naze@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical infectious complications. (time frame: Baseline - 60 minutes after administration). The study lists 4 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 Mar 2022.