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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Metronidazole and Amoxicillin | Experimental | Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days. |
|
| Lactobacillus reuteri | Experimental | Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Oral Tablet | Drug | Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth change | The change in the probing depth will be measure in millimeters before and after the treatment. | Baseline, 30 and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque Index | Number of teeth affected before and after periodontal treatment. | Baseline, 30 and 90 days |
| Gingival Index | Number of teeth affected before and after the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Jardini, PhD | Universidade Estadual Paulista Julio de Mesquita Filho | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Jardini | São José dos Campos | São Paulo | 1224500 | Brazil |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D057747 | Periodontal Debridement |
| D000658 | Amoxicillin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D003777 | Dental Prophylaxis |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D000667 | Ampicillin |
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Parallel Assignment Prospective double-blind randomized controlled clinical study with a 90-days follow-up.
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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.
| Amoxicillin 500 Mg | Drug | 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 Drops | Drug | 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. |
|
|
| Baseline, 30 and 90 days |
| Gingival Recession | Evaluated in milimeters before and after the treatment. | Baseline, 30 and 90 days |
| Clinical Attachment Level | Evaluated in milimeters before and after the treatment. | 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. | 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. | Baseline, 30 and 90 days |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010400 |
| Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |