Microbial ColonizationPhase 4NCT04580355
Impact of Non-surgical Periodontal Therapy on Oral and Gut Microbiome
A Phase 4 study testing One-Stage Full Mouth Debridement, Amoxicillin 500mg and Metronidazole 400mg in people with Microbial Colonization and Periodontal Diseases, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. Several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Microbial Colonization, Periodontal Diseases, Periodontal Inflammation
- What is being tested?
- One-Stage Full Mouth Debridement, Amoxicillin 500mg and Metronidazole 400mg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2021to Oct 2022
- 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Stage III/IV and grade C Periodontitis
- Presence of at least 20 teeth
- Good general health
Who cannot join
- Pregnant or lactating
- Were suffering from any other systemic diseases (e.g., cardiovascular, diabetes)
- Received antimicrobials in the previous 6 months
- Received a course of periodontal treatment within the last 6 months
- Were taking long-term anti-inflammatory drugs
- Smoking habits
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Campinas, UNICAMP
Piracicaba, São Paulo, 13414-903
Renato CV Casarin, Prof. Dr., +55192106-5394, casarinrcv@yahoo.com.br
About this study
Official title: Impact of Non-surgical Periodontal Therapy With or Without Antibiotics on Oral and Gut Microbiome in Patients With Stage III/IV and Grade C Periodontitis
Periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. Several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. In order to clarify the impact of periodontal condition on gut microbiome, we aim to evaluate the clinical, immunological parameters and the microbiological condition by sequencing of subgingival biofilm and stool samples both before and after non-surgical periodontal treatment with and without antibiotics as adjunct.
- Being tested
- One-Stage Full Mouth Debridement, Amoxicillin 500mg, Metronidazole 400mg, Amoxicillin Placebo, Metronidazole Placebo
- Medical subject headings
- Communicable Diseases, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Stage Full Mouth DebridementProcedure or surgery
Periodontal debridement
Amoxicillin 500mgDrug
Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.
Metronidazole 400mgDrug
Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days.
Amoxicillin PlaceboDrug
Administration of Placebo on the day of treatment tid for 7 days.
Metronidazole PlaceboDrug
Administration of Placebo on the day of treatment tid for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| FMUD + Placebos | Experimental | One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus placebo administration prescribed on the day of treatment, every 8 hours for 7 days. Receives: Procedure: One-Stage Full Mouth Debridement; Drug: Amoxicillin Placebo; Drug: Metronidazole Placebo |
| FMUD + AM | Active comparator | One session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 500 mg Amoxicillin and 250 mg Metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days. Receives: Procedure: One-Stage Full Mouth Debridement; Drug: Amoxicillin 500mg; Drug: Metronidazole 400mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the oral-gut axis microbiome at 3 months
Concentration of bacteria in the subgingival biofilm and stool samples
Measured: Baseline and 90 days
Secondary outcomes (3)
Change of biofilm gene expression on oral microbiome at 3 months
RNA-seq of 3 samples FMUD+AM group and validation by quantitative polymerase chain reaction
Measured: Baseline and 90 days
Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples
Concentration of cytokines and biomarkers in gingival crevicular fluid and in stool samples
Measured: Baseline and 90 days
Change of the baseline relative clinical attachment level at 3 months
Distance from the bottom of the pocket to the stent margin.
Measured: Baseline, 30 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study startJul 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Casarin, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580355
- Sponsor's protocol ID
- 23626219.7.0000.5418
- Status last verified
- May 2021
- First submitted
- 1 Oct 2020
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-surgical Periodontal Therapy With or Without Antibiotics on Oral and Gut Microbiome in Patients With Stage III/IV and Grade C Periodontitis
- ClinicalTrials.gov ID
- NCT04580355
- Acronym / sponsor ID
- 23626219.7.0000.5418
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Oct 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.
Periodontitis is an inflammatory disease characterized by a dysbiotic microbiome which can lead to bone destruction and tooth loss. Several studies had been reported the association to periodontal disease with systemic conditions and this relation suggests and axis that links oral and gut microbiome. In order to clarify the impact of periodontal condition on gut microbiome, we aim to evaluate the clinical, immunological parameters and the microbiological condition by sequencing of subgingival biofilm and stool samples both before and after non-surgical periodontal treatment with and without antibiotics as adjunct.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMUD + Placebos | Experimental | Procedure: One-Stage Full Mouth Debridement, Drug: Amoxicillin Placebo, Drug: Metronidazole PlaceboOne session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus placebo administration prescribed on the day of treatment, every 8 hours for 7 days. |
| FMUD + AM | Active comparator | Procedure: One-Stage Full Mouth Debridement, Drug: Amoxicillin 500mg, Drug: Metronidazole 400mgOne session of full-mouth ultrasonic debridement (FMUD) with a time limit of 45 minutes plus 500 mg Amoxicillin and 250 mg Metronidazole (AM) prescribed on the day of treatment, every 8 hours for 7 days. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of Stage III/IV and grade C Periodontitis
- Presence of at least 20 teeth
- Good general health
Key exclusion criteria (6 listed)
- Pregnant or lactating
- Were suffering from any other systemic diseases (e.g., cardiovascular, diabetes)
- Received antimicrobials in the previous 6 months
- Received a course of periodontal treatment within the last 6 months
- Were taking long-term anti-inflammatory drugs
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 |
|---|---|---|
| One-Stage Full Mouth DebridementPeriodontal debridement | Procedure or surgery | FMUD + AM, FMUD + Placebos |
| Amoxicillin 500mgAdministration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days. | Drug | FMUD + AM |
| Metronidazole 400mgAdministration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days. | Drug | FMUD + AM |
| Amoxicillin PlaceboAdministration of Placebo on the day of treatment tid for 7 days. | Drug | FMUD + Placebos |
| Metronidazole PlaceboAdministration of Placebo on the day of treatment tid for 7 days. | Drug | FMUD + Placebos |
Primary outcome
Change in the oral-gut axis microbiome at 3 months
Time frame: Baseline and 90 days
Concentration of bacteria in the subgingival biofilm and stool samples
3 secondary outcomes
Change of biofilm gene expression on oral microbiome at 3 months
Time frame: Baseline and 90 days
Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) and stool samples
Time frame: Baseline and 90 days
Change of the baseline relative clinical attachment level at 3 months
Time frame: Baseline, 30 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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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.
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 One-Stage Full Mouth Debridement, Amoxicillin 500mg and Metronidazole 400mg in people with Microbial Colonization and Periodontal Diseases, run by University of Campinas, Brazil at 1 site in Brazil.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 May 2021. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the oral-gut axis microbiome at 3 months (time frame: Baseline and 90 days). 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 May 2021; AzTrials last refreshed its copy on 8 Nov 2026.