Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bacteremia in Periodontal Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02215473
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
University of Taubate

Brief 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.

Condition or disease Intervention/treatment Phase
Gingivitis Periodontitis Drug: Chlorhexidine gluconate mouth rinse Procedure: Periodontal instrumentation Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial
Study Start Date : August 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: gingivitis mouth rinse Drug: Chlorhexidine gluconate mouth rinse
Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds). Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.

Procedure: Periodontal instrumentation
Individuals only received local oral anesthesia before periodontal instrumentation. Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.

Experimental: periodontitis mouth rinse Drug: Chlorhexidine gluconate mouth rinse
Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds). Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.

Procedure: Periodontal instrumentation
Individuals only received local oral anesthesia before periodontal instrumentation. Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.

Active Comparator: gingivitis no mouth rinse Procedure: Periodontal instrumentation
Individuals only received local oral anesthesia before periodontal instrumentation. Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.

Active Comparator: periodontitis no mouth rinse Procedure: Periodontal instrumentation
Individuals only received local oral anesthesia before periodontal instrumentation. Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.




Primary Outcome Measures :
  1. Changes on viable bacterial levels in blood [ Time Frame: 2 and 6 minutes ]
    To check a possible antimicrobial effect after a single mouth rinse use, the levels of viable anaerobic and aerobic bacterial cels were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes. Blood samples were collected and spread out onto agar plates to determine total levels of aerobic and anaerobic bacteria. Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.


Secondary Outcome Measures :
  1. Changes on levels of bacterial DNA in blood [ Time Frame: 2 and 6 months ]
    To check a possible antimicrobial effect after a single mouth rinse use, the levels of bacterial DNA in blood samples were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes. Blood samples were collected and analyzed by real time PCR (polymerase chain reaction) to determine total bacterial load and levels of target periodontal pathogens. Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild to moderate plaque related gingivitis (gingivitis group)
  • mild to moderate periodontitis (periodontitis group)
  • at least 20 natural teeth
  • with no recognized systemic risk related to bacteremia
  • no need for antibiotic prophylaxis before dental procedures

Exclusion Criteria:

  • systemic diseases or other conditions that could influence the periodontal status;
  • alcohol or other drugs abuse;
  • orthodontic devices;
  • extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
  • pregnancy or breast-feeding;
  • history of sensitivity or suspected allergies following the use of chlorhexidine;
  • antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
  • regular use of chemotherapeutic antiplaque/antigingivitis products;
  • any furcation lesions;
  • periodontal treatment performed within six months prior to study initiation;
  • unwillingness to return for follow-up.

Information from the National Library of Medicine

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): NCT02215473


Locations
Layout table for location information
Brazil
Nucleus of periodontal research of University of Taubate
Taubate, SP, Brazil, 12020330
Sponsors and Collaborators
University of Taubate
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Layout table for investigator information
Principal Investigator: Jose R Cortelli, PhD University of Taubate

Layout table for additonal information
Responsible Party: University of Taubate
ClinicalTrials.gov Identifier: NCT02215473     History of Changes
Other Study ID Numbers: BPP
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by University of Taubate:
gingivitis
periodontitis
mouth rinse
bacteremia

Additional relevant MeSH terms:
Layout table for MeSH terms
Chlorhexidine
Chlorhexidine gluconate
Periodontitis
Bacteremia
Gingivitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Gingival Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents