Alternative Antibiotic Regimen in Periodontitis Treatment

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353362
• Other study ID #: Istanbul Medipol
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: April 2020
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 10, 2020
• Est. primary completion date: January 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Amoxicillin
• Metronidazole
• Ofloxacin
• Periodontitis
• Root Planing

Intervention

Drug:
• Ofloxacin
400 mg, 1 time per day for 5 days
• Amoxicillin
500 mg, 3 times per day for 7 days
• Metronidazole
500 mg, 3 times per day, for 7 days

Locations

Country	Name	City	State
Turkey	Begum Alkan	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical attachment loss	Clinical attachment loss was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.	6-months