Antibiotic and Probiotic Therapies in the Adjuvant Treatment of the Chronic Periodontitis.
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|ClinicalTrials.gov Identifier: NCT03692819|
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis Complex||Drug: Placebo Oral Tablet Drug: Amoxicillin 500 Mg Drug: Lactobacillus reuteri Oral Drops||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment Prospective double-blind randomized controlled clinical study with a 180-days follow-up.|
|Masking:||Triple (Care Provider, 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.|
|Official Title:||Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.|
|Actual Study Start Date :||May 2, 2018|
|Estimated Primary Completion Date :||May 3, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Active Comparator: placebo
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.
Drug: Placebo Oral Tablet
Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
Other Name: Periodontal debridement
Experimental: Metronidazole and Amoxicillin
Periodontal debridement treatment in a single session Metronidazole 400mg + Amoxicillin 500mg every 8 hours for 7 days.
Drug: Amoxicillin 500 Mg
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
Other Name: Metronidazole Oral
Experimental: Lactobacillus reuteri
Periodontal debridement treatment in a single session Lactobacillus reuteri Oral Drops twice a day for 21 days.
Drug: Lactobacillus reuteri Oral Drops
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.
Other Name: Prodentis
- Probing Depth change [ Time Frame: 30, 90 and 180 days ]The change in the probing depth will be measure in millimeters before and after the treatment.
- Plaque Index [ Time Frame: Baseline, 30, 90 and 180 days ]Number of teeth affected before and after periodontal treatment.
- Gingival Index [ Time Frame: Baseline,30,90 and 180 days ]Number of teeth affected before and after the treatment.
- Gingival Recession [ Time Frame: Baseline,30, 90 and 180 days ]Evaluated in milimeters before and after the treatment.
- Clinical Attachment Level [ Time Frame: Baseline,30, 90 and 180 days ]Evaluated in milimeters before and after the treatment.
- Periodontal Inflamed Surface Area (PISA) [ Time Frame: Baseline,30, 90 and 180 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 [ Time Frame: Baseline,30, 90 and 180 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692819
|Contact: Maria Jardini, PhD||55 12 39479046 ext firstname.lastname@example.org|
|Contact: Tatiane Ramos, DDS|
|São José dos Campos, São Paulo, Brazil, 1224500|
|Contact: Maria Jardini, PhD 55 12 39479046 email@example.com|
|Study Director:||Maria Jardini, PhD||Universidade Estadual Paulista Julio de Mesquita Filho|