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

Anti-bacterial Agents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172207
• Other study ID #: Istanbul Medipol University
• Status: Completed
• Start date: October 15, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: November 2019
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 15, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anti-bacterial Agents
• Chromosome-defective Micronuclei
• Cytology
• Histopathology

Intervention

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.

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	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
Primary	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