AmoxicillinPhase 4NCT04353362
Alternative Antibiotic Regimen in Periodontitis Treatment
A Phase 4 study testing Ofloxacin, Amoxicillin and Metronidazole in people with Amoxicillin and Metronidazole, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Amoxicillin, Metronidazole, Ofloxacin
- What is being tested?
- Ofloxacin, Amoxicillin and Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 10 Mar 2020
- Phase
- Phase 4
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ofloxacin and Metronidazole/Amoxicillin on the Treatment of Periodontitis.
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).
Read more
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.
- Conditions
- Amoxicillin, Metronidazole, Ofloxacin, Periodontitis, Root Planing
- Being tested
- Ofloxacin, Amoxicillin, Metronidazole
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfloxacinDrug
400 mg, 1 time per day for 5 days
AmoxicillinDrug
500 mg, 3 times per day for 7 days
MetronidazoleDrug
500 mg, 3 times per day, for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Ofloxacin group | Experimental | Not described Receives: Drug: Ofloxacin |
| Amoxicillin plus Metronidazole group | Active comparator | Not described Receives: Drug: Amoxicillin; Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
Probing depth was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
Measured: 6-months
Secondary outcomes (1)
Clinical attachment loss
Clinical attachment loss was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Apr 2017
- Primary completion2 Jan 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmoxicillinStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 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
- NCT04353362
- Sponsor's protocol ID
- Istanbul Medipol
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ofloxacin and Metronidazole/Amoxicillin on the Treatment of Periodontitis.
- ClinicalTrials.gov ID
- NCT04353362
- Acronym / sponsor ID
- Istanbul Medipol
- Conditions
- Amoxicillin, Metronidazole, Ofloxacin, Periodontitis, Root Planing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 2 Jan 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 20 Apr 2020 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ofloxacin group | Experimental | Drug: Ofloxacin |
| Amoxicillin plus Metronidazole group | Active comparator | Drug: Amoxicillin, Drug: Metronidazole |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Ofloxacin400 mg, 1 time per day for 5 days | Drug | Ofloxacin group |
| Amoxicillin500 mg, 3 times per day for 7 days | Drug | Amoxicillin plus Metronidazole group |
| Metronidazole500 mg, 3 times per day, for 7 days | Drug | Amoxicillin plus Metronidazole group |
Primary outcome
Probing depth
Time frame: 6-months
Probing depth was recorded at the baseline, first, third, and sixth month. The changes were evaluated among and between groups.
1 secondary outcome
Clinical attachment loss
Time frame: 6-months
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 20 Apr 2020.
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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?
A Phase 4 study testing Ofloxacin, Amoxicillin and Metronidazole in people with Amoxicillin and Metronidazole, 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 1 inclusion and 1 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 20 Apr 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Probing depth (time frame: 6-months). 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 20 Apr 2020.