PeriodontitisPhase 3NCT03733379
Systemic Probiotics in the Periodontal Treatment
A Phase 3 study testing Scaling and root planing, Metronidazole and Amoxicillin in people with Periodontitis, run by Belén Retamal-Valdes at 2 sites in Brazil.
Trial summary
The aim of this multicenter randomized clinical trial is to evaluate the clinical, microbiological and immunological effects of probiotics as an adjunct to Scaling and Root Planing alone or in combination with Metronidazole and Amoxicillin in the treatment of periodontitis. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Scaling and root planing, Metronidazole and Amoxicillin
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 2 sitesBrazil
- Study dates
- 5 Nov 2018to 30 Dec 2021
- Phase
- Phase 3
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥30 years of age;
- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction);
- a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm;
- at least 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥4 mm and bleeding on probing (BOP);
Who cannot join
- pregnancy;
- breastfeeding;
- current smoking and former smoking within the past 5 years;
- systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
- scaling and root planing an in the previous 12 months;
- antibiotic therapy in the previous 6 months;
Show all 11Show fewer
- long-term intake of anti-inflammatory medications;
- need for antibiotic pre-medication for routine dental therapy;
- use of orthodontic appliances;
- extensive dental prosthetic rehabilitation;
- allergy to metronidazole and/or amoxicillin.
Trial locations and contacts
2 sites in 1 country.
Magda Feres, Professor contact
Brazil2 sites, 2 recruiting
- Recruiting
Federal University of Paraná
Curitiba, Paraná, 80210170
Geisla Soares, Professor, +55 (41) 33604134, geisla.soares@ufpr.br
Natalie Temporão, Master student, +55 (41) 99960339, natalie.temporao@gmail.com
- Not yet recruiting
University of Guarulhos
Guarulhos, São Paulo, 07023-070
Belén Retamal-Valdes, Professor, +55 (11) 942801064, belenretamalvaldes@gmail.com
Magda Feres, Professor, mferes@ung.br
About this study
Official title: Clinical, Microbiological and Immunological Evaluation of the Effects of Systemic Probiotics in the Periodontal Treatment
The aim of this multicenter randomized clinical trial is to evaluate the clinical, microbiological and immunological effects of probiotics as an adjunct to Scaling and Root Planing alone or in combination with Metronidazole and Amoxicillin in the treatment of periodontitis.
Read the detailed description
The association of scaling and root planing (SRP) with systemic metronidazole (MTZ) and amoxicillin (AMX) has been advocated as one of the most promising therapeutic protocol for the treatment of advanced periodontitis, since the early 2000's. More recently, probiotics has also been suggested as a promising adjunctive treatment for periodontitis due to their antimicrobial and anti-inflammatory properties. Therefore, the aim of this study is to evaluate the clinical, microbiological and immunological effects of probiotics as an adjunct to SRP alone or in combination with MTZ and AMX in the treatment of periodontitis. In this randomized, double-blind, placebo-controlled trial, subjects with periodontitis will be randomly assigned to receive (i) SRP alone, or combined with: (ii) two probiotics lozenges a day for 90 days (Prob), (iii) 400 of MTZ, plus AMX (500 mg) thrice a day (TID) for 14 days (MTZ+AMX), or (iv) Prob and MTZ+AMX. Subjects will be monitored up to 1 year post-therapy. Nine subgingival plaque samples will be collected at baseline and at 3, 6 and 12 months post-therapy; three samples in each of the following pockets categories: shallow (probing depth [PD]≤3 mm), moderate (PD=4-6 mm) and deep (PD≥7 mm). The microbiological samples will be analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species. Two non-contiguous diseased sites (i.e PD and CAL ≥ 5mm, bleeding and probing [BOP] and no furcation involvement) and two non-contiguous healthy sites (i.e. PD and clinical attachment level [CAL] ≤ 4 mm without BoP and/or marginal bleeding) will be randomly chosen per patient for gingival crevicular fluid (GCF) sampling, from the same sites selected for the microbiological monitoring. Peripheral blood samples will also be collected one week after clinical examination. The GCF and blood samples will be analyzed using a multi-analyte method by means of a 17-multiplex fluorescent bead-based immunoassay for 17 cyto/chemokines. The significance of differences over the course of the study will be sought using repeated measures ANOVA and Tukey multiple comparison tests, and at each time point (among groups) using either ANOVA and Tukey multiple comparison tests or ANCOVA with adjustments for the baseline values. The Chi-square test will be used to compare the differences in the frequency of gender, and to compare the differences in the frequency of subjects achieving the clinical endpoint at 1 year and of self-perceived adverse effects. A stepwise forward logistic regression analysis will be performed in order to investigate the impact of predictor variables on the clinical endpoint for treatment, i.e., "presence of ≤4 sites with PD≥5 mm at 12 months post-therapy (yes/no)". The Number Needed to Treat (NNT) with adjunctive antibiotic in order to obtain treatment success (≤4 sites with PD ≥5 mm) will be calculated. The level of significance will be set at 5%.
- Conditions
- Periodontitis
- Being tested
- Scaling and root planing, Metronidazole and Amoxicillin placebos, Metronidazole, Amoxicillin, Probiotic
- Keywords
- Periodontitis, Probiotic, Metronidazole, Amoxicillin, Scaling and root planing, Periodontal treatment
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Also called SRP
SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.
Metronidazole and Amoxicillin placebosDrug
Amoxicillin and metronidazole placebos thrice a day for 14 days (beginning with the first SRP session).
MetronidazoleDrug
Metronidazole 400 mg thrice a day for 14 days (beginning with the first SRP session).
AmoxicillinDrug
Amoxicillin 500 mg thrice a day for 14 days (beginning with the first SRP session).
ProbioticDietary supplement
The probiotic contains 2 different strains of Lactobacillus reuteri: L.reuteri DSM 17938 and L. reuteri ATCC PTA 5289 each at a concentration of 1 x 108 CFU per tablet. It will be used 2 times per day by 90 days.
Probiotic placeboDietary supplement
The placebo is identical to the active but without L. reuteri. The two Study Products are identical in taste, texture and shape. It will be used 2 times per day by 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Scaling and root planing + Placebos of Metronidazole and Amoxicillin three times a day (TID) for 14 days + placebo lozenges of probiotics two times a day for 90 days. Receives: Procedure: Scaling and root planing; Drug: Metronidazole and Amoxicillin placebos; Dietary Supplement: Probiotic placebo |
| Probiotic | Experimental | Scaling and root planing + Placebos of Metronidazole and Amoxicillin three times a day (TID) for 14 days + lozenges of probiotics two times a day for 90 days. Receives: Procedure: Scaling and root planing; Drug: Metronidazole and Amoxicillin placebos; Dietary Supplement: Probiotic |
| Antibiotic | Experimental | Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days + placebo lozenges of probiotics two times a day for 90 days. Receives: Procedure: Scaling and root planing; Drug: Metronidazole; Drug: Amoxicillin |
| Antibiotic + probiotic | Experimental | Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days + lozenges of probiotics two times a day for 90 days. Receives: Procedure: Scaling and root planing; Drug: Metronidazole; Drug: Amoxicillin; Dietary Supplement: Probiotic placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Measured: 12 months
Secondary outcomes (27)
Number of sites with PD ≥ 5 mm.
Measured: Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 6 mm.
Measured: Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 7 mm.
Measured: Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 5 mm.
Measured: Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 6 mm
Measured: Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 7 mm
Measured: Baseline, 3, 6 and 12 months
Mean PD changes in sites with initial PD between 4-6 mm
Measured: Baseline - 12 months
Mean PD changes in sites with initial PD ≥ 7 mm.
Measured: Baseline - 12 months
Mean CAL changes in sites with initial CAL between 4-6 mm
Measured: Baseline - 12 months
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Measured: Baseline - 12 months
Full-mouth Probing Depth (mm).
Measured: Baseline, 3, 6 and 12 months
Full-mouth Clinical Attachment Level (mm)
Measured: Baseline, 3, 6 and 12 months
Percentage of sites with bleeding on probing
Measured: Baseline, 3, 6 and 12 months
Percentage of sites with plaque accumulation
Measured: Baseline, 3, 6 and 12 months
Percentage of sites with marginal bleeding
Measured: Baseline, 3, 6 and 12 months
Occurrence of headache obtained through a questionnaire of adverse effects
Measured: 14 days after taking antibiotic
Occurrence of headache obtained through a questionnaire of adverse effects
Measured: 90 days after taking probiotic
Occurrence of vomiting obtained through a questionnaire of adverse effects
Measured: 14 days after taking antibiotic
Occurrence of vomiting obtained through a questionnaire of adverse effects
Measured: 90 days after taking probiotic
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Measured: 90 days after taking probiotic
Occurrence of nausea obtained through a questionnaire of adverse effects.
Measured: 14 days after taking antibiotic
Occurrence of nausea obtained through a questionnaire of adverse effects.
Measured: 90 days after taking probiotic
Proportions of periodontal pathogenic bacterial species.
Measured: Baseline, 3, 6 and 12 months
Counts of periodontal pathogenic bacterial species.
Measured: Baseline, 3, 6 and 12 months
Counts of chemokines in the crevicular gingival fluid.
Measured: Baseline and 12 months
Counts of chemokines in the peripheral blood samples
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start5 Nov 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belén Retamal-Valdes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Belén Retamal-Valdes, University of Guarulhos
- Investigators
- Magda Feres, Professor, Principal investigator, University of Guarulhos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733379
- Sponsor's protocol ID
- CAAE: 74049717.7.1001.5506
- Status last verified
- Jan 2020
- First submitted
- 5 Nov 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.
PubMed 25494600Feres M, Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Figueiredo LC. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Dec;39(12):1149-58. doi: 10.1111/jcpe.12004. Epub 2012 Sep 27.
PubMed 23016867Borges I, Faveri M, Figueiredo LC, Duarte PM, Retamal-Valdes B, Montenegro SCL, Feres M. Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial. J Clin Periodontol. 2017 Aug;44(8):822-832. doi: 10.1111/jcpe.12721. Epub 2017 Jul 26.
PubMed 28303587Laleman I, Yilmaz E, Ozcelik O, Haytac C, Pauwels M, Herrero ER, Slomka V, Quirynen M, Alkaya B, Teughels W. The effect of a streptococci containing probiotic in periodontal therapy: a randomized controlled trial. J Clin Periodontol. 2015 Nov;42(11):1032-41. doi: 10.1111/jcpe.12464. Epub 2015 Nov 29.
PubMed 26427036Retamal-Valdes B, Teughels W, Oliveira LM, da Silva RN, Fritoli A, Gomes P, Soares GMS, Temporao N, Furquim CP, Duarte PM, Doyle H, Faveri M, Figueiredo LC, Feres M. Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial. Trials. 2021 Apr 15;22(1):283. doi: 10.1186/s13063-021-05246-0.
PubMed 33858486
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Microbiological and Immunological Evaluation of the Effects of Systemic Probiotics in the Periodontal Treatment
- ClinicalTrials.gov ID
- NCT03733379
- Acronym / sponsor ID
- CAAE: 74049717.7.1001.5506
- Conditions
- Periodontitis
- Keywords
- Periodontitis, Probiotic, Metronidazole, Amoxicillin, Scaling and root planing, Periodontal treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Belén Retamal-ValdesUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 7 Nov 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.
The aim of this multicenter randomized clinical trial is to evaluate the clinical, microbiological and immunological effects of probiotics as an adjunct to Scaling and Root Planing alone or in combination with Metronidazole and Amoxicillin in the treatment of periodontitis.
Detailed description
The association of scaling and root planing (SRP) with systemic metronidazole (MTZ) and amoxicillin (AMX) has been advocated as one of the most promising therapeutic protocol for the treatment of advanced periodontitis, since the early 2000's. More recently, probiotics has also been suggested as a promising adjunctive treatment for periodontitis due to their antimicrobial and anti-inflammatory properties. Therefore, the aim of this study is to evaluate the clinical, microbiological and immunological effects of probiotics as an adjunct to SRP alone or in combination with MTZ and AMX in the treatment of periodontitis. In this randomized, double-blind, placebo-controlled trial, subjects with periodontitis will be randomly assigned to receive (i) SRP alone, or combined with: (ii) two probiotics lozenges a day for 90 days (Prob), (iii) 400 of MTZ, plus AMX (500 mg) thrice a day (TID) for 14 days (MTZ+AMX), or (iv) Prob and MTZ+AMX. Subjects will be monitored up to 1 year post-therapy. Nine subgingival plaque samples will be collected at baseline and at 3, 6 and 12 months post-therapy; three samples in each of the following pockets categories: shallow (probing depth [PD]≤3 mm), moderate (PD=4-6 mm) and deep (PD≥7 mm). The microbiological samples will be analyzed by checkerboard DNA-DNA hybridization for 40 bacterial species. Two non-contiguous diseased sites (i.e PD and CAL ≥ 5mm, bleeding and probing [BOP] and no furcation involvement) and two non-contiguous healthy sites (i.e. PD and clinical attachment level [CAL] ≤ 4 mm without BoP and/or marginal bleeding) will be randomly chosen per patient for gingival crevicular fluid (GCF) sampling, from the same sites selected for the microbiological monitoring. Peripheral blood samples will also be collected one week after clinical examination. The GCF and blood samples will be analyzed using a multi-analyte method by means of a 17-multiplex fluorescent bead-based immunoassay for 17 cyto/chemokines. The significance of differences over the course of the study will be sought using repeated measures ANOVA and Tukey multiple comparison tests, and at each time point (among groups) using either ANOVA and Tukey multiple comparison tests or ANCOVA with adjustments for the baseline values. The Chi-square test will be used to compare the differences in the frequency of gender, and to compare the differences in the frequency of subjects achieving the clinical endpoint at 1 year and of self-perceived adverse effects. A stepwise forward logistic regression analysis will be performed in order to investigate the impact of predictor variables on the clinical endpoint for treatment, i.e., "presence of ≤4 sites with PD≥5 mm at 12 months post-therapy (yes/no)". The Number Needed to Treat (NNT) with adjunctive antibiotic in order to obtain treatment success (≤4 sites with PD ≥5 mm) will be calculated. The level of significance will be set at 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Procedure: Scaling and root planing, Drug: Metronidazole and Amoxicillin placebos, Dietary Supplement: Probiotic placeboScaling and root planing + Placebos of Metronidazole and Amoxicillin three times a day (TID) for 14 days + placebo lozenges of probiotics two times a day for 90 days. |
| Probiotic | Experimental | Procedure: Scaling and root planing, Drug: Metronidazole and Amoxicillin placebos, Dietary Supplement: ProbioticScaling and root planing + Placebos of Metronidazole and Amoxicillin three times a day (TID) for 14 days + lozenges of probiotics two times a day for 90 days. |
| Antibiotic | Experimental | Procedure: Scaling and root planing, Drug: Metronidazole, Drug: AmoxicillinScaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days + placebo lozenges of probiotics two times a day for 90 days. |
| Antibiotic + probiotic | Experimental | Procedure: Scaling and root planing, Drug: Metronidazole, Drug: Amoxicillin, Dietary Supplement: Probiotic placeboScaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days + lozenges of probiotics two times a day for 90 days. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥30 years of age;
- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction);
- a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical attachment level (CAL) ≥5 mm;
- at least 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥4 mm and bleeding on probing (BOP);
Key exclusion criteria (11 listed)
- pregnancy;
- breastfeeding;
- current smoking and former smoking within the past 5 years;
- systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
- scaling and root planing an in the previous 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 |
|---|---|---|
| Scaling and root planingAlso: SRPSRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days. | Procedure or surgery | Antibiotic, Antibiotic + probiotic, Control, Probiotic |
| Metronidazole and Amoxicillin placebosAmoxicillin and metronidazole placebos thrice a day for 14 days (beginning with the first SRP session). | Drug | Control, Probiotic |
| MetronidazoleMetronidazole 400 mg thrice a day for 14 days (beginning with the first SRP session). | Drug | Antibiotic, Antibiotic + probiotic |
| AmoxicillinAmoxicillin 500 mg thrice a day for 14 days (beginning with the first SRP session). | Drug | Antibiotic, Antibiotic + probiotic |
| ProbioticThe probiotic contains 2 different strains of Lactobacillus reuteri: L.reuteri DSM 17938 and L. reuteri ATCC PTA 5289 each at a concentration of 1 x 108 CFU per tablet. It will be used 2 times per day by 90 days. | Dietary supplement | Probiotic |
| Probiotic placeboThe placebo is identical to the active but without L. reuteri. The two Study Products are identical in taste, texture and shape. It will be used 2 times per day by 90 days. | Dietary supplement | Antibiotic + probiotic, Control |
Primary outcome
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
Time frame: 12 months
27 secondary outcomes
Number of sites with PD ≥ 5 mm.
Time frame: Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 6 mm.
Time frame: Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 7 mm.
Time frame: Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 5 mm.
Time frame: Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 6 mm
Time frame: Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 7 mm
Time frame: Baseline, 3, 6 and 12 months
Mean PD changes in sites with initial PD between 4-6 mm
Time frame: Baseline - 12 months
Mean PD changes in sites with initial PD ≥ 7 mm.
Time frame: Baseline - 12 months
Mean CAL changes in sites with initial CAL between 4-6 mm
Time frame: Baseline - 12 months
Mean CAL changes in sites with initial CAL ≥ 7 mm.
Time frame: Baseline - 12 months
Full-mouth Probing Depth (mm).
Time frame: Baseline, 3, 6 and 12 months
Full-mouth Clinical Attachment Level (mm)
Time frame: Baseline, 3, 6 and 12 months
Percentage of sites with bleeding on probing
Time frame: Baseline, 3, 6 and 12 months
Percentage of sites with plaque accumulation
Time frame: Baseline, 3, 6 and 12 months
Percentage of sites with marginal bleeding
Time frame: Baseline, 3, 6 and 12 months
Occurrence of headache obtained through a questionnaire of adverse effects
Time frame: 14 days after taking antibiotic
Occurrence of headache obtained through a questionnaire of adverse effects
Time frame: 90 days after taking probiotic
Occurrence of vomiting obtained through a questionnaire of adverse effects
Time frame: 14 days after taking antibiotic
Occurrence of vomiting obtained through a questionnaire of adverse effects
Time frame: 90 days after taking probiotic
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic
Occurrence of diarrhea obtained through a questionnaire of adverse effects.
Time frame: 90 days after taking probiotic
Occurrence of nausea obtained through a questionnaire of adverse effects.
Time frame: 14 days after taking antibiotic
Occurrence of nausea obtained through a questionnaire of adverse effects.
Time frame: 90 days after taking probiotic
Proportions of periodontal pathogenic bacterial species.
Time frame: Baseline, 3, 6 and 12 months
Counts of periodontal pathogenic bacterial species.
Time frame: Baseline, 3, 6 and 12 months
Counts of chemokines in the crevicular gingival fluid.
Time frame: Baseline and 12 months
Counts of chemokines in the peripheral blood samples
Time frame: Baseline and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 25494600Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.
- Results publication: PubMed 23016867Feres M, Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Figueiredo LC. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Dec;39(12):1149-58. doi: 10.1111/jcpe.12004. Epub 2012 Sep 27.
- Results publication: PubMed 28303587Borges I, Faveri M, Figueiredo LC, Duarte PM, Retamal-Valdes B, Montenegro SCL, Feres M. Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial. J Clin Periodontol. 2017 Aug;44(8):822-832. doi: 10.1111/jcpe.12721. Epub 2017 Jul 26.
- Results publication: PubMed 26427036Laleman I, Yilmaz E, Ozcelik O, Haytac C, Pauwels M, Herrero ER, Slomka V, Quirynen M, Alkaya B, Teughels W. The effect of a streptococci containing probiotic in periodontal therapy: a randomized controlled trial. J Clin Periodontol. 2015 Nov;42(11):1032-41. doi: 10.1111/jcpe.12464. Epub 2015 Nov 29.
- Derived from this study: PubMed 33858486Retamal-Valdes B, Teughels W, Oliveira LM, da Silva RN, Fritoli A, Gomes P, Soares GMS, Temporao N, Furquim CP, Duarte PM, Doyle H, Faveri M, Figueiredo LC, Feres M. Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial. Trials. 2021 Apr 15;22(1):283. doi: 10.1186/s13063-021-05246-0.
- Individual participant dataSharing planned: Undecided
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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.
Magda Feres, Professor contact
Magda Feres, Professor principal investigator
University of Guarulhos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Scaling and root planing, Metronidazole and Amoxicillin in people with Periodontitis, run by Belén Retamal-Valdes at 2 sites 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 4 inclusion and 11 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Belén Retamal-Valdes, Professor (+55 (11) 942801064, belenretamalvaldes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733379, which also lists 5 linked publications.
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 13 Jan 2020.