Bacteremia in Periodontal Patients
11. august 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
80
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
SP
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Taubate, SP, Brasil, 12020330
- Nucleus of periodontal research of University of Taubate
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 45 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: gingivitis 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.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
|
|
Eksperimentell: periodontitis 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.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
|
|
Aktiv komparator: gingivitis no mouth rinse
|
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
|
|
Aktiv komparator: periodontitis no mouth rinse
|
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes on viable bacterial levels in blood
Tidsramme: 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.
|
2 and 6 minutes
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes on levels of bacterial DNA in blood
Tidsramme: 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.
|
2 and 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jose R Cortelli, PhD, University of Taubate
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2013
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. desember 2013
Datoer for studieregistrering
Først innsendt
8. august 2014
Først innsendt som oppfylte QC-kriteriene
11. august 2014
Først lagt ut (Anslag)
13. august 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. august 2014
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Infeksjoner
- Systemisk inflammatorisk responssyndrom
- Betennelse
- Stomatognatiske sykdommer
- Periodontale sykdommer
- Munnsykdommer
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Sepsis
- Gingival sykdommer
- Periodontitt
- Gingivitt
- Bakteremi
- Anti-infeksjonsmidler, lokale
- Anti-infeksjonsmidler
- Dermatologiske midler
- Desinfeksjonsmidler
- Klorheksidin
- Klorheksidinglukonat
Andre studie-ID-numre
- BPP
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