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Bacteremia in Periodontal Patients

Primary Purpose

Gingivitis, Periodontitis

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Chlorhexidine gluconate mouth rinse
Periodontal instrumentation
Sponsored by
University of Taubate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring gingivitis, periodontitis, mouth rinse, bacteremia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nucleus of periodontal research of University of Taubate

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

gingivitis mouth rinse

periodontitis mouth rinse

gingivitis no mouth rinse

periodontitis no mouth rinse

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 8, 2014
Last Updated
August 11, 2014
Sponsor
University of Taubate
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT02215473
Brief Title
Bacteremia in Periodontal Patients
Official Title
Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Taubate
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontitis
Keywords
gingivitis, periodontitis, mouth rinse, bacteremia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gingivitis mouth rinse
Arm Type
Experimental
Arm Title
periodontitis mouth rinse
Arm Type
Experimental
Arm Title
gingivitis no mouth rinse
Arm Type
Active Comparator
Arm Title
periodontitis no mouth rinse
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate mouth rinse
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Periodontal instrumentation
Intervention Description
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 Measure Information:
Title
Changes on viable bacterial levels in blood
Description
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.
Time Frame
2 and 6 minutes
Secondary Outcome Measure Information:
Title
Changes on levels of bacterial DNA in blood
Description
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.
Time Frame
2 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose R Cortelli, PhD
Organizational Affiliation
University of Taubate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nucleus of periodontal research of University of Taubate
City
Taubate
State/Province
SP
ZIP/Postal Code
12020330
Country
Brazil

12. IPD Sharing Statement

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Bacteremia in Periodontal Patients

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