Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
Primary Purpose
Chronic Periodontitis Complex
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Placebo Oral Tablet
Amoxicillin 500 Mg
Lactobacillus reuteri Oral Drops
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis Complex focused on measuring Chronic Periodontitis, Periodontal Debridement, Antibiotics, Probiotics
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Maria Jardini
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
placebo
Metronidazole and Amoxicillin
Lactobacillus reuteri
Arm Description
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.
Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days.
Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days.
Outcomes
Primary Outcome Measures
Probing Depth change
The change in the probing depth will be measure in millimeters before and after the treatment.
Secondary Outcome Measures
Plaque Index
Number of teeth affected before and after periodontal treatment.
Gingival Index
Number of teeth affected before and after the treatment.
Gingival Recession
Evaluated in milimeters before and after the treatment.
Clinical Attachment Level
Evaluated in milimeters before and after the treatment.
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.
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.
Full Information
NCT ID
NCT03692819
First Posted
September 6, 2018
Last Updated
November 13, 2020
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
1. Study Identification
Unique Protocol Identification Number
NCT03692819
Brief Title
Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
Official Title
Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
August 20, 2020 (Actual)
Study Completion Date
September 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis Complex
Keywords
Chronic Periodontitis, Periodontal Debridement, Antibiotics, Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
In addition to concealment of randomization, the investigator responsible for the procedures of periodontal therapy (periodontal debridement) and the researcher responsible for the measurements will not know which treatment each group will receive, characterizing the blindness of the study.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Metronidazole and Amoxicillin
Arm Type
Experimental
Arm Description
Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days.
Arm Title
Lactobacillus reuteri
Arm Type
Experimental
Arm Description
Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Periodontal debridement
Intervention Description
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin 500 Mg
Other Intervention Name(s)
Metronidazole Oral
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lactobacillus reuteri Oral Drops
Other Intervention Name(s)
Prodentis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Probing Depth change
Description
The change in the probing depth will be measure in millimeters before and after the treatment.
Time Frame
Baseline, 30 and 90 days
Secondary Outcome Measure Information:
Title
Plaque Index
Description
Number of teeth affected before and after periodontal treatment.
Time Frame
Baseline, 30 and 90 days
Title
Gingival Index
Description
Number of teeth affected before and after the treatment.
Time Frame
Baseline, 30 and 90 days
Title
Gingival Recession
Description
Evaluated in milimeters before and after the treatment.
Time Frame
Baseline, 30 and 90 days
Title
Clinical Attachment Level
Description
Evaluated in milimeters before and after the treatment.
Time Frame
Baseline, 30 and 90 days
Title
Periodontal Inflamed Surface Area (PISA)
Description
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.
Time Frame
Baseline, 30 and 90 days
Title
Microbiological Parameters
Description
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.
Time Frame
Baseline, 30 and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jardini, PhD
Organizational Affiliation
Universidade Estadual Paulista Julio de Mesquita Filho
Official's Role
Study Director
Facility Information:
Facility Name
Maria Jardini
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
1224500
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
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