Chronic Periodontitis Complex Clinical Trial
Official title:
Effect of Antibiotic and Probiotic Therapies in the Adjuvant Treatment of Chronic Periodontitis: Randomized Controlled Clinical Trial.
| Verified date | November 2020 |
| Source | Universidade Estadual Paulista Júlio de Mesquita Filho |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | September 20, 2020 |
| Est. primary completion date | August 20, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years to 50 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Maria Jardini | São José dos Campos | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade Estadual Paulista Júlio de Mesquita Filho |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Probing Depth change | The change in the probing depth will be measure in millimeters before and after the treatment. | Baseline, 30 and 90 days | |
| Secondary | Plaque Index | Number of teeth affected before and after periodontal treatment. | Baseline, 30 and 90 days | |
| Secondary | Gingival Index | Number of teeth affected before and after the treatment. | Baseline, 30 and 90 days | |
| Secondary | Gingival Recession | Evaluated in milimeters before and after the treatment. | Baseline, 30 and 90 days | |
| Secondary | Clinical Attachment Level | Evaluated in milimeters before and after the treatment. | Baseline, 30 and 90 days | |
| Secondary | 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 | |
| Secondary | 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 |