Chronic Periodontitis ComplexNCT03692819
Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
A study testing Amoxicillin 500 Mg and Lactobacillus reuteri Oral Drops in people with Chronic Periodontitis Complex, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Chronic Periodontitis Complex
- What is being tested?
- Amoxicillin 500 Mg and Lactobacillus reuteri Oral Drops
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2018to 20 Sep 2020
- Phase
- Interventional
- 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 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals between 35 and 50 years of age;
- Be diagnosed with generalized chronic periodontitis: present a loss of interproximal clinical insertion> 3 mm in 2 nonadjacent teeth and loss of interproximal clinical insertion ≥5 mm, in 30% or more of the teeth present;
- Present at least 16 teeth;
- Present good systemic health;
- Agree to participate in the study and sign the informed consent form
Who cannot join
- Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, among others), which do not indicate the periodontal procedure;
- Have undergone periodontal treatment in the last twelve months;
- Have used antibiotics and/or anti-inflammatories for the past six months;
- Smoking patients;
- Pregnancy or Lactation;
- Chronic use of medications that may alter the response of periodontal tissues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.
Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and microbiological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis.
Read the detailed description
Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and immunological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis. Patients will be randomized into 3 groups: Group 1 (n=15): periodontal debridement, Group 2 (n=15): periodontal debridement associated with antibiotic (Metronidazole 400 mg + Amoxicillin 500mg) and Group 3 (n=15): periodontal debridement associated with probiotic (Lactobacillus reuteri). Clinical (plaque index, gingival index, probing depth, gingival recession, relative clinical attachment level and periodontal inflamed surface area (PISA) index) and immunological data obtained before and after periodontal therapy (baseline, 30 and 90) will be consolidated and made available on average ± standard deviation and normality tested using the Shapiro-Wilk test. For statistical analysis, the software BioEstat 5.0 (Belém, PA, Brazil) will be used, with p-value < 0,05.
- Conditions
- Chronic Periodontitis Complex
- Being tested
- Placebo Oral Tablet, Amoxicillin 500 Mg, Lactobacillus reuteri Oral Drops
- Keywords
- Chronic Periodontitis, Periodontal Debridement, Antibiotics, Probiotics
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral TabletDrug
Also called Periodontal debridement
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
Amoxicillin 500 MgDrug
Also called Metronidazole Oral
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the antibiotic (Metronidazole 400mg + Amoxicillin 500mg) every 8 hours for 7 days
Lactobacillus reuteri Oral DropsDrug
Also called Prodentis
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the probiotic (Lactobacillus reuteri oral drops ) twice a day for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Active comparator | Periodontal debridement treatment will be performed in a single session after the therapy will be administered the Placebo Oral Tablet twice a day for 21 days. Receives: Drug: Placebo Oral Tablet |
| Metronidazole and Amoxicillin | Experimental | Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days. Receives: Drug: Amoxicillin 500 Mg |
| Lactobacillus reuteri | Experimental | Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days. Receives: Drug: Lactobacillus reuteri Oral Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth change
The change in the probing depth will be measure in millimeters before and after the treatment.
Measured: Baseline, 30 and 90 days
Secondary outcomes (6)
Plaque Index
Number of teeth affected before and after periodontal treatment.
Measured: Baseline, 30 and 90 days
Gingival Index
Number of teeth affected before and after the treatment.
Measured: Baseline, 30 and 90 days
Gingival Recession
Evaluated in milimeters before and after the treatment.
Measured: Baseline, 30 and 90 days
Clinical Attachment Level
Evaluated in milimeters before and after the treatment.
Measured: Baseline, 30 and 90 days
Periodontal Inflamed Surface Area (PISA)
Is calculated from data collected on probing the periodontal pocket and are placed in a table which gives the value of the periodontal inflamed surface area.
Measured: Baseline, 30 and 90 days
Microbiological Parameters
crevicular fluid samples will be analyzed by PCR (real time PCR) for detection and quantification of: Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Lactobacillus reuteri.
Measured: Baseline, 30 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 posted2 Oct 2018
- Study start2 May 2018
- Primary completion20 Aug 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Periodontitis ComplexStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Maria Jardini, PhD, Study director, Universidade Estadual Paulista Julio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692819
- Sponsor's protocol ID
- Probioticos e Antibióticos
- Status last verified
- Nov 2020
- First submitted
- 6 Sep 2018
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03692819
- Acronym / sponsor ID
- Probioticos e Antibióticos
- Conditions
- Chronic Periodontitis Complex
- Keywords
- Chronic Periodontitis, Periodontal Debridement, Antibiotics, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 20 Aug 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 2 Oct 2018 (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.
Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and microbiological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis.
Detailed description
Currently, with the increase of bacterial resistance to antibiotics associated with its side effects, it is necessary to find other adjuncts to combat the disease that are an alternative to the use of antibiotics. The use of probiotics has been proposed in the literature as an adjunct therapy for the treatment of periodontal diseases, however, few controlled and randomized clinical studies have been performed. The objective of this double-blind randomized controlled trial will be to evaluate the response of clinical and immunological periodontal parameters to the comparison of two different adjuvant therapies (antibiotic and probiotic) for the treatment of stages II and III grade B periodontitis. Patients will be randomized into 3 groups: Group 1 (n=15): periodontal debridement, Group 2 (n=15): periodontal debridement associated with antibiotic (Metronidazole 400 mg + Amoxicillin 500mg) and Group 3 (n=15): periodontal debridement associated with probiotic (Lactobacillus reuteri). Clinical (plaque index, gingival index, probing depth, gingival recession, relative clinical attachment level and periodontal inflamed surface area (PISA) index) and immunological data obtained before and after periodontal therapy (baseline, 30 and 90) will be consolidated and made available on average ± standard deviation and normality tested using the Shapiro-Wilk test. For statistical analysis, the software BioEstat 5.0 (Belém, PA, Brazil) will be used, with p-value < 0,05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
| Arm | Type | Receives |
|---|---|---|
| placebo | Active comparator | Drug: Placebo Oral TabletPeriodontal debridement treatment will be performed in a single session after the therapy will be administered the Placebo Oral Tablet twice a day for 21 days. |
| Metronidazole and Amoxicillin | Experimental | Drug: Amoxicillin 500 MgPeriodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days. |
| Lactobacillus reuteri | Experimental | Drug: Lactobacillus reuteri Oral DropsPeriodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals between 35 and 50 years of age;
- Be diagnosed with generalized chronic periodontitis: present a loss of interproximal clinical insertion> 3 mm in 2 nonadjacent teeth and loss of interproximal clinical insertion ≥5 mm, in 30% or more of the teeth present;
- Present at least 16 teeth;
- Present good systemic health;
- Agree to participate in the study and sign the informed consent form
Key exclusion criteria (6 listed)
- Patients with systemic problems (cardiovascular changes, blood dyscrasias, immunodeficiency, among others), which do not indicate the periodontal procedure;
- Have undergone periodontal treatment in the last twelve months;
- Have used antibiotics and/or anti-inflammatories for the past six months;
- Smoking patients;
- Pregnancy or Lactation;
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 |
|---|---|---|
| Placebo Oral TabletAlso: Periodontal debridementNon-surgical periodontal treatment will be performed by means of periodontal debridement in a single session. | Drug | placebo |
| Amoxicillin 500 MgAlso: Metronidazole OralNon-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the antibiotic (Metronidazole 400mg + Amoxicillin 500mg) every 8 hours for 7 days | Drug | Metronidazole and Amoxicillin |
| Lactobacillus reuteri Oral DropsAlso: ProdentisNon-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the probiotic (Lactobacillus reuteri oral drops ) twice a day for 21 days. | Drug | Lactobacillus reuteri |
Primary outcome
Probing Depth change
Time frame: Baseline, 30 and 90 days
The change in the probing depth will be measure in millimeters before and after the treatment.
6 secondary outcomes
Plaque Index
Time frame: Baseline, 30 and 90 days
Gingival Index
Time frame: Baseline, 30 and 90 days
Gingival Recession
Time frame: Baseline, 30 and 90 days
Clinical Attachment Level
Time frame: Baseline, 30 and 90 days
Periodontal Inflamed Surface Area (PISA)
Time frame: Baseline, 30 and 90 days
Microbiological Parameters
Time frame: Baseline, 30 and 90 days
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 17 Nov 2020.
- 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.
Maria Jardini, PhD study director
Universidade Estadual Paulista Julio de Mesquita Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin 500 Mg and Lactobacillus reuteri Oral Drops in people with Chronic Periodontitis Complex, run by Universidade Estadual Paulista Júlio de Mesquita Filho 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 5 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: finished, as of the sponsor's last update on 17 Nov 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 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.
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 change (time frame: Baseline, 30 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 17 Nov 2020.