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OpenTrials
Completed

NCT Number: NCT04353362

Alternative Antibiotic Regimen in Periodontitis Treatment

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.

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Key information

Conditions

Amoxicillin Metronidazole Mouth Diseases Ofloxacin Periodontal Diseases Periodontitis Root Planing Stomatognathic Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Begum Alkan

Istanbul, 34230, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ofloxacin

Drug

400 mg, 1 time per day for 5 days

Amoxicillin

Drug

500 mg, 3 times per day for 7 days

Metronidazole

Drug

500 mg, 3 times per day, for 7 days

Primary outcomes

  1. Probing depth

    Time frame: 6-months

    Probing depth was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.

Secondary outcomes

  1. Clinical attachment loss

    Time frame: 6-months

    Clinical attachment loss was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Comparison of Ofloxacin and Metronidazole/Amoxicillin on the Treatment of Periodontitis.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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