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

Effects of Antibiotic Consumption Time on Gingival-biopsy and Oral-smear Samples.

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.

Study Overview

• Status: Completed
• Conditions: Anti-bacterial Agents; Cytology; Histopathology; Chromosome-defective Micronuclei
• Intervention / Treatment: Other: Sampling

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34230
    • Begüm Alkan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 45 systemically and periodontally healthy participants, who were referred to the clinics of the Department of Periodontology, Faculty of Dentistry, Istanbul Medipol University between 2018 and 2019 for routine periodontal visits, were included in this study. Participants were divided into three groups based on the history of oral antibiotic (1 g amoxicillin bid, two times a day) consumption for upper respiratory tract infection in the previous 12 months: group I (n = 19), participants used antibiotic between 12-6 months before the sampling; group II (n = 13), participants used antibiotic between 6-3 months before the sampling; group III (n = 13), participants used antibiotic within a period of 1-month before to sampling.

Description

Inclusion Criteria:

• Systemically and periodontally healthy participants
• Presence of probing depth (PD) of ≤ 3 mm14 and bleeding on probing (BOP) ˂ 10%15
• No clinical evidence of gingival recession (GR), clinic attachment loss or radiographic evidence of alveolar bone loss
• No periodontal treatment within the last 12 months

Exclusion Criteria:

• Smoking, alcohol or drug abuse
• Any systemic condition would affect the periodontal health (i.e., pregnancy, lactation, ovulation, and diabetes mellitus)
• A history of contagious disease
• Periodontal treatment within the last 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Results of study groups.	Other: Sampling; After periodontal parameters measured, smear samples were obtained from the buccal mucosa and keratinized gingiva, and then a gingival biopsy was performed from the upper premolars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of antibiotics on gingiva confirmed by histopathology.	Modified histological criteria was the measurement used for the semi-quantitative histological assessment of gingival damage. Cellular components, vascularization, cell infiltration, necrosis, pyknotic nucleus, hyperemia, fibrosis, ulceration, atrophy, apoptosis, and rete peg configuration were scored by using a scale ranging from 0 to 3 (none : 0, mild: 1, moderate: 2, and severe : 3) for each criterion.	1-week
Effects of antibiotics on buccal and oral smear confirmed by quantitative determination of the micronuclei.	The method has been applied both for monitoring chromosome damage and/or proteins may also result in unsuccessful attachment of a whole chromosome at anaphase stage which subsequently also gives rise to a micronucleus. Thus, quantitative determination of the micronuclei are unique amongst cytogenetic tests in that it provides a reliable measure of both chromosome loss and breakage.	1-week

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 22, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Micronuclei, Chromosome-Defective
• Other Study ID Numbers: Istanbul Medipol University (Other Identifier: Istanbul Medipol University Ethics Committee Decision No: 855/2021)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No