Alternative Antibiotic Regimen in Periodontitis Treatment

Phase 4

Completed

• Conditions: Amoxicillin; Metronidazole; Periodontitis; Ofloxacin; Root Planing
• Interventions: Drug: Amoxicillin; Drug: Ofloxacin; Drug: Metronidazole

• Registration Number: NCT04353362
• Lead Sponsor: Istanbul Medipol University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2020-01-02
• Study Completion: 2020-03-10
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-16
• Last Update Submitted: 2020-04-16
• Study First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amoxicillin plus Metronidazole group	Metronidazole	-
Amoxicillin plus Metronidazole group	Amoxicillin	-
Ofloxacin group	Ofloxacin	-

Primary Outcome Measures

Name	Time	Method
Probing depth	6-months	Probing depth was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.

Secondary Outcome Measures

Name	Time	Method
Clinical attachment loss	6-months	Clinical attachment loss was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.

Trial Locations

Locations (1)

Begum Alkan; 🇹🇷 Istanbul, Turkey