Back to resultsAlternative Antibiotic Regimen in Periodontitis Treatment
Primary Purpose
Amoxicillin, Metronidazole, Ofloxacin
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ofloxacin
Amoxicillin
Metronidazole
Sponsored by
About this trial
This is an interventional supportive care trial for Amoxicillin
Eligibility Criteria
Inclusion Criteria:
- The periodontal diagnosis of participants with generalized periodontitis stage III-IV/grade C. Systemically healthy participants with generalized periodontitis were enrolled if they were between 18 and 40 years of age, and had no allergies to penicillin, metronidazole or quinolones, a history of antibiotic therapy or periodontal therapy within the preceding six months
Exclusion Criteria:
- Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status, allergies to quinolones, penicillin or metronidazole, a history of antibiotic therapy, or periodontal treatment within the preceding six months
Sites / Locations
- Begum Alkan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ofloxacin group
Amoxicillin plus Metronidazole group
Arm Description
Outcomes
Primary Outcome Measures
Probing depth
Probing depth was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
Secondary Outcome Measures
Clinical attachment loss
Clinical attachment loss was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
Full Information
NCT ID
NCT04353362
First Posted
April 15, 2020
Last Updated
April 16, 2020
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04353362
Brief Title
Alternative Antibiotic Regimen in Periodontitis Treatment
Official Title
Comparison of Ofloxacin and Metronidazole/Amoxicillin on the Treatment of Periodontitis.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 2, 2020 (Actual)
Study Completion Date
March 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Context and Aims: Several studies have demonstrated an association between obesity, periodontitis, and exercise. This study aimed to investigate the effects of regular exercise on obese women with periodontal disease, using serum, saliva, and gingival crevicular fluid (GCF) samples.
Settings and Design: A before-after study design was adopted to evaluate the effects of 12 weeks of regular exercise on obese women grouped according to periodontal status, without a control group (no exercise).
Methods and Material: The study sample comprised fifteen patients without periodontitis (NP group) and 10 patients with chronic periodontitis (CP group), from whom periodontal parameters were measured and serum, saliva, and GCF samples were collected. Body mass index (BMI), anthropometric measurements, somatotype-motoric tests, and maximal oxygen consumption (VO2max) were recorded at baseline and after exercise.
Statistical analysis used: MedCalc was used for statistical analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amoxicillin, Metronidazole, Ofloxacin, Periodontitis, Root Planing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ofloxacin group
Arm Type
Experimental
Arm Title
Amoxicillin plus Metronidazole group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ofloxacin
Intervention Description
400 mg, 1 time per day for 5 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
500 mg, 3 times per day for 7 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
500 mg, 3 times per day, for 7 days
Primary Outcome Measure Information:
Title
Probing depth
Description
Probing depth was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Clinical attachment loss
Description
Clinical attachment loss was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
Time Frame
6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The periodontal diagnosis of participants with generalized periodontitis stage III-IV/grade C. Systemically healthy participants with generalized periodontitis were enrolled if they were between 18 and 40 years of age, and had no allergies to penicillin, metronidazole or quinolones, a history of antibiotic therapy or periodontal therapy within the preceding six months
Exclusion Criteria:
Subjects were excluded if they had any known systemic diseases or conditions that can/could influence the periodontal status, allergies to quinolones, penicillin or metronidazole, a history of antibiotic therapy, or periodontal treatment within the preceding six months
Facility Information:
Facility Name
Begum Alkan
City
Istanbul
ZIP/Postal Code
34230
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Alternative Antibiotic Regimen in Periodontitis Treatment
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