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

Primary Purpose

Impacted Third Molar Tooth, Impacted Molar

Status
Recruiting
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Dalacin C
Sponsored by
Oral and Maxillofacial Surgery Clinic, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring impacted third molars, post operative pain, trismus, infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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:

    1. 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.
    2. 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

Exclusion Criteria:

  • 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)
  • 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:

    1. Breast-feeding subject.
    2. Positive urine pregnancy test at screening
    3. 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:

      1. condom + spermicide,
      2. diaphragm + spermicide,
      3. intra-uterine contraceptive device (placed at least 4 weeks prior to study drug administration

Sites / Locations

  • OMFS ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Clindamycin 150mg

Clindamycin 300mg

Clindamycin 600mg

Arm Description

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

Patients receiving 300mg of clindamycin after surgery every 8 hours

Patients receiving 600mg of clindamycin after surgery every 12 hours

Outcomes

Primary Outcome Measures

Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Post-surgical infectious complications.
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2022
Last Updated
March 4, 2022
Sponsor
Oral and Maxillofacial Surgery Clinic, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT05268835
Brief Title
Different Oral Doses of Clindamycin in Preventing Post-operative Sequelae of Lower Third Molar Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oral and Maxillofacial Surgery Clinic, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth, Impacted Molar
Keywords
impacted third molars, post operative pain, trismus, infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clindamycin 150mg
Arm Type
Active Comparator
Arm Description
Patients receiving 150mg of clindamycin (Dalacin C, Pfizer) after surgery every 8 hours
Arm Title
Clindamycin 300mg
Arm Type
Active Comparator
Arm Description
Patients receiving 300mg of clindamycin after surgery every 8 hours
Arm Title
Clindamycin 600mg
Arm Type
Active Comparator
Arm Description
Patients receiving 600mg of clindamycin after surgery every 12 hours
Intervention Type
Drug
Intervention Name(s)
Dalacin C
Intervention Description
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
Primary Outcome Measure Information:
Title
Post-surgical infectious complications.
Description
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Time Frame
Baseline - 60 minutes after administration
Title
Post-surgical infectious complications.
Description
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Time Frame
24 hours after surgery
Title
Post-surgical infectious complications.
Description
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Time Frame
48 hours after surgery
Title
Post-surgical infectious complications.
Description
May occur with one or more of the following: pain, fever, swelling, trismus, dry socket.
Time Frame
7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Janas-Naze, DMD,PhD,Prof
Phone
7164485
Ext
004842
Email
anna.janas.naze@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Janas-Naze, DMD,PhD,Prof
Organizational Affiliation
OMFS Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
OMFS Clinic
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Janas-Naze, DMD,PhD,Prof
Phone
7164485
Ext
004842
Email
anna.janas.naze@gmail.com
First Name & Middle Initial & Last Name & Degree
Anna Janas-Naze, DMD,PhD,Prof

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
If the results are published, the data will be stored at repository with doi.
IPD Sharing Time Frame
in a year
IPD Sharing Access Criteria
If the results are published, the data will be stored at repository with doi.

Learn more about this trial

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

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