Systemic Probiotics in the Periodontal Treatment
Clinical, Microbiological and Immunological Evaluation of the Effects of Systemic Probiotics in the Periodontal Treatment
1 other identifier
interventional
176
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2018
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2018
CompletedStudy Start
First participant enrolled
November 5, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJanuary 13, 2020
January 1, 2020
2.2 years
November 5, 2018
January 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months
12 months
Secondary Outcomes (27)
Number of sites with PD ≥ 5 mm.
Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 6 mm.
Baseline, 3, 6 and 12 months
Number of sites with PD ≥ 7 mm.
Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 5 mm.
Baseline, 3, 6 and 12 months
Change in the number of sites with PD ≥ 6 mm
Baseline, 3, 6 and 12 months
- +22 more secondary outcomes
Study Arms (4)
Control
PLACEBO COMPARATORScaling 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
EXPERIMENTALScaling 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
EXPERIMENTALScaling 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
EXPERIMENTALScaling 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.
Interventions
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.
Amoxicillin and metronidazole placebos thrice a day for 14 days (beginning with the first SRP session).
Metronidazole 400 mg thrice a day for 14 days (beginning with the first SRP session).
Amoxicillin 500 mg thrice a day for 14 days (beginning with the first SRP session).
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.
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.
Eligibility Criteria
You may qualify if:
- ≥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);
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Federal University of Paraná
Curitiba, Paraná, 80210170, Brazil
University of Guarulhos
Guarulhos, São Paulo, 07023-070, Brazil
Related Publications (5)
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.
PMID: 25494600BACKGROUNDFeres 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.
PMID: 23016867RESULTBorges 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.
PMID: 28303587RESULTLaleman 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.
PMID: 26427036RESULTRetamal-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.
PMID: 33858486DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magda Feres, Professor
University of Guarulhos
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 5, 2018
First Posted
November 7, 2018
Study Start
November 5, 2018
Primary Completion
December 30, 2020
Study Completion
December 30, 2021
Last Updated
January 13, 2020
Record last verified: 2020-01