NCT04172207

Antibiotic, Gingival-biopsy, and Oral-smear Samples.

Completed Last updated 26 November 2019

What this trial tests

trial testing Sampling in Anti-bacterial Agents in 45 participants. Completed in 15 September 2019.

Timeline

15 October 2018

Primary endpoint
15 June 2019

15 September 2019

Quick facts

Lead sponsor	Istanbul Medipol University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	45
Start date	15 October 2018
Primary completion	15 June 2019
Estimated completion	15 September 2019
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Sampling — full drug profile →

Conditions studied

• Anti-bacterial Agents — all drugs for Anti-bacterial Agents →
• Chromosome-defective Micronuclei — all drugs for Chromosome-defective Micronuclei →
• Cytology — all drugs for Cytology →
• Histopathology — all drugs for Histopathology →

Sponsor

Istanbul Medipol University Hospital

Who can join

Adults 18 to 60, any sex, with Anti-bacterial Agents or Chromosome-defective Micronuclei. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Antimicrobial or antibiotic agents, which are essential to prevent and treat bacterial infectious diseases, have become one of the most widely used drugs in the world. In the European region, the highest rates of antibiotic consumption are reported in Turkey. There is a nearly fivefold difference between Turkey and the lowest consuming countries.

Studies in dentistry evaluate participants according to the basis of predefined criteria. History of antibiotic consumption is one of the most common exclusion criteria for periodontal trials. However, there is still disagreement on how long the effect of systemic antibiotic agents on the oral mucosa and periodontal tissue lasts. It is unclear whether the timing of antibiotic consumption should be an exclusion criterion for genetic damage and histological studies during the selection of healthy participants.

Periodontal status of participants in study groups is described as with or without periodontitis in many studies, because of the lack of clear definitions of periodontal health and gingivitis. It should be recognized that even the lack of visual signs of inflammation, some mild histopathological changes can be seen in the periodontium. Consequently, for the real diagnosis of the clinically healthy periodontium, clinical findings should be supported and confirmed with histological results.

Micronuclei (Mn) are observed as abnormal nuclear structures and indicators of chromosomal level DNA damage. The oral mucosa epithelium is an immunologic barrier and affected by chemical factors such as antibiotic consumption. The Mn test to exfoliated epithelial cells from the oral cavity is utilized as a non-invasive diagnostic technique for monitoring the status of oral health. To our knowledge, no studies have been conducted on the comparison of the impacts of the timing of antibiotic consumption on human periodontal tissues and oral smear samples. The present study is undertaken to determine whether the different timing of antibiotic (amoxicillin) therapy has effects on the histopathology of gingiva and genetic damage of exfoliated cells from oral mucosa in healthy participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.