Chronic Periodontitis Complex
Conditions
Keywords
Chronic Periodontitis, Periodontal Debridement, Antibiotics, Probiotics
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.
Interventions
DRUGPlacebo Oral Tablet
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
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
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.
Sponsors
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes 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.
Intervention model description
Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probing Depth change | Baseline, 30 and 90 days | The change in the probing depth will be measure in millimeters before and after the treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index | Baseline, 30 and 90 days | Number of teeth affected before and after periodontal treatment. |
| Gingival Index | Baseline, 30 and 90 days | Number of teeth affected before and after the treatment. |
| Gingival Recession | Baseline, 30 and 90 days | Evaluated in milimeters before and after the treatment. |
| Clinical Attachment Level | Baseline, 30 and 90 days | Evaluated in milimeters before and after the treatment. |
| Periodontal Inflamed Surface Area (PISA) | Baseline, 30 and 90 days | 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 | Baseline, 30 and 90 days | 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. |
Countries
Brazil
Outcome results
None listed