Alternative Antibiotic Regimen in Periodontitis Treatment

NCT ID: NCT04353362

Last Updated: 2020-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-03-10

Brief Summary

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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.

Detailed Description

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Conditions

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Amoxicillin Metronidazole Ofloxacin Periodontitis Root Planing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Ofloxacin group

Group Type EXPERIMENTAL

Ofloxacin

Intervention Type DRUG

400 mg, 1 time per day for 5 days

Amoxicillin plus Metronidazole group

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

500 mg, 3 times per day for 7 days

Metronidazole

Intervention Type DRUG

500 mg, 3 times per day, for 7 days

Interventions

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Ofloxacin

400 mg, 1 time per day for 5 days

Intervention Type DRUG

Amoxicillin

500 mg, 3 times per day for 7 days

Intervention Type DRUG

Metronidazole

500 mg, 3 times per day, for 7 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Begum Alkan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Begum Alkan

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Istanbul Medipol

Identifier Type: -

Identifier Source: org_study_id

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