Bacteremia in Periodontal Patients

Periodontitis Clinical Trial

Official title:

Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215473
• Other study ID #: BPP
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2014
• Last updated: August 11, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2014
• Source: University of Taubate
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Ethics Committee CONEPBrazil: National Sanitary Agency ANVISA
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

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

• Bacteremia
• Gingivitis
• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Nucleus of periodontal research of University of Taubate	Taubate	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Taubate	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on viable bacterial levels in blood	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.	2 and 6 minutes	No
Secondary	Changes on levels of bacterial DNA in blood	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.	2 and 6 months	No