Bacteremia in Periodontal Patients

Status Completed

Clinical Trial Summary

Bacteremia represents the presence of live germs in the blood stream. Patients with gum disease show damaged tissues and seem to be more susceptible to bacteremia. In fact, daily activities such as mastication can induce bacteremia in these patients. Dental procedures related to bleeding also induce bacteremia. However, there are many questions that should be clarified. Among them, clinical strategies that are able to reduce the levels of germs in blood should be determined. This desirable effect could be particularly important for some patients, for example, for those at higher risk for endocarditis. Therefore, this study tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental instrumentation could reduce the levels of bacteria in the blood. In addition, the occurrence and magnitude of bacteremia in patients with gum disease were investigated by two different laboratorial techniques. After receiving verbal and written explanations and after signed the informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse use and dental instrumentation and b) dental instrumentation with no mouth rinse. In a preliminary visit volunteers underwent a complete periodontal examination which included clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue and dental plaque samples collected with paper points), saliva (to determine volume and biological indicators) and gingival crevicular fluid sampling (to monitor gingival inflammation profile). In the next visit, dental instrumentation was performed under local anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant. Blood samples were collected before any dental procedure, 2 and 6 minutes after dental instrumentation. Oral hygiene instructions and periodontal treatment were performed in additional visits according to individual needs. Finally, the relation between bacteremia and several indicators of periodontal status was investigated.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02215473
Study type	Interventional
Source	University of Taubate
Contact
Status	Completed
Phase	Phase 4
Start date	August 2013
Completion date	December 2013

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.