Alternative Antibiotic Regimen in Periodontitis Treatment
Comparison of Ofloxacin and Metronidazole/Amoxicillin on the Treatment of Periodontitis.
1 other identifier
interventional
74
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2017
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedFirst Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedApril 20, 2020
April 1, 2020
2.8 years
April 15, 2020
April 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Probing depth
Probing depth was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
6-months
Secondary Outcomes (1)
Clinical attachment loss
6-months
Study Arms (2)
Ofloxacin group
EXPERIMENTALAmoxicillin plus Metronidazole group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Begum Alkan
Istanbul, 34230, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 20, 2020
Study Start
April 1, 2017
Primary Completion
January 2, 2020
Study Completion
March 10, 2020
Last Updated
April 20, 2020
Record last verified: 2020-04