Different Oral Doses of Clindamycin in Preventing Post-operative Sequelae of Lower Third Molar Surgery

NCT05268835 | Unknown Phase 4

• 1 other identifier: 001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Impacted Third Molar Tooth; Impacted Molar

Keywords

impacted third molars; post operative pain; trismus; infection

Outcome Measures

Primary Outcomes (4)

• Post-surgical infectious complications.

  May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.

  Baseline - 60 minutes after administration

• Post-surgical infectious complications.

  May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.

  24 hours after surgery

• Post-surgical infectious complications.

  May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.

  48 hours after surgery

• Post-surgical infectious complications.

  May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.

  7 days after surgery

Study Arms (3)

Clindamycin 150mg

ACTIVE COMPARATOR

Patients receiving 150mg of clindamycin (Dalacin C, Pfizer) after surgery every 8 hours

Drug: Dalacin C

Clindamycin 300mg

ACTIVE COMPARATOR

Patients receiving 300mg of clindamycin after surgery every 8 hours

Drug: Dalacin C

Clindamycin 600mg

ACTIVE COMPARATOR

Patients receiving 600mg of clindamycin after surgery every 12 hours

Drug: Dalacin C

Interventions

Dalacin C DRUG

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

Clindamycin 150mg; Clindamycin 300mg; Clindamycin 600mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Oral and Maxillofacial Surgery Clinic, Poland: lead

Study Sites (1)

OMFS Clinic

Zgierz, 95-100, Poland

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Trismus; Infections

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Anna Janas-Naze, DMD,PhD,Prof

  OMFS Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Janas-Naze, DMD,PhD,Prof

CONTACT

7164485; anna.janas.naze@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 7, 2022
• Study Start: February 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: in a year
• Access Criteria: If the results are published, the data will be stored at repository with doi.

Locations

PL (1)