Anti-bacterial AgentsNCT04172207
Antibiotic, Gingival-biopsy, and Oral-smear Samples.
An observational study of Anti-bacterial Agents and Chromosome-defective Micronuclei, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anti-bacterial Agents, Chromosome-defective Micronuclei, Cytology
- What is being tested?
- Sampling
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 15 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Sampling
- Medical subject headings
- Micronuclei, Chromosome-Defective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Results of study groups. | Not described Receives: Other: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start15 Oct 2018
- Primary completion15 Jun 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-bacterial AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begum Alkan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172207
- Sponsor's protocol ID
- Istanbul Medipol University
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antibiotic Consumption Time on Gingival-biopsy and Oral-smear Samples.
- ClinicalTrials.gov ID
- NCT04172207
- Acronym / sponsor ID
- Istanbul Medipol University
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Results of study groups. | – | Other: Sampling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplingAfter 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. | Other | Results of study groups. |
Primary outcome
Effects of antibiotics on gingiva confirmed by histopathology.
Time frame: 1-week
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.
Effects of antibiotics on buccal and oral smear confirmed by quantitative determination of the micronuclei.
Time frame: 1-week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-bacterial Agents and Chromosome-defective Micronuclei, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of antibiotics on gingiva confirmed by histopathology. (time frame: 1-week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.