Bacteremia in Periodontal Patients
11 augustus 2014 bijgewerkt door: University of Taubate
Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
80
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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SP
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Taubate, SP, Brazilië, 12020330
- Nucleus of periodontal research of University of Taubate
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: gingivitis mouth rinse
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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.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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Experimenteel: periodontitis mouth rinse
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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.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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Actieve vergelijker: gingivitis no mouth rinse
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Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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Actieve vergelijker: periodontitis no mouth rinse
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Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes on viable bacterial levels in blood
Tijdsspanne: 2 and 6 minutes
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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.
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2 and 6 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Changes on levels of bacterial DNA in blood
Tijdsspanne: 2 and 6 months
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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.
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2 and 6 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jose R Cortelli, PhD, University of Taubate
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 augustus 2013
Primaire voltooiing (Werkelijk)
1 december 2013
Studie voltooiing (Werkelijk)
1 december 2013
Studieregistratiedata
Eerst ingediend
8 augustus 2014
Eerst ingediend dat voldeed aan de QC-criteria
11 augustus 2014
Eerst geplaatst (Schatting)
13 augustus 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
13 augustus 2014
Laatste update ingediend die voldeed aan QC-criteria
11 augustus 2014
Laatst geverifieerd
1 augustus 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Infecties
- Systemisch ontstekingsreactiesyndroom
- Ontsteking
- Stomatognatische ziekten
- Parodontale aandoeningen
- Mondziekten
- Bacteriële infecties
- Bacteriële infecties en mycosen
- Sepsis
- Tandvleesaandoeningen
- Parodontitis
- Gingivitis
- Bacteriëmie
- Anti-infectiemiddelen, lokaal
- Anti-infectieuze middelen
- Dermatologische middelen
- Ontsmettingsmiddelen
- Chloorhexidine
- Chloorhexidinegluconaat
Andere studie-ID-nummers
- BPP
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