- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01046435
Effects of Periodontal Therapy on Systemic Inflammation
Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease.
Methods: The current study is a randomized, double blind clinical trial, with two treatment groups.
Eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed.
The study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension.
The periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and >30 % of sites with bleeding on probing.
The outcomes measures will be levels of serum C-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Santiago, Chile
- Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Clinically diagnosis of marginal periodontitis
- No history of periodontal treatment
- At least 14 natural teeth present
- Dyslipidemia
And at least one of the following factors:
- obesity
- diabetes
- smoking, hypertension
Exclusion Criteria:
- Rheumatoid arthritis
- Any type of cancer in the previous 2 years
- Pregnancy and lactation
- Indication of the use of antibiotic for invasive procedures
- Use of antibiotics in previous three months.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Supragingival scaling plus placebo
Plaque control instructions, supra gingival scaling and two placebos
|
Metronidazole 250 mg three times a day per 7 days
Andre navn:
Two placebos 3 times a day for 7 days
Andre navn:
|
|
Eksperimentell: Root planing plus antibiotics
Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg.
three times a day for 7 days
|
Metronidazole 250 mg three times a day per 7 days
Andre navn:
Two placebos 3 times a day for 7 days
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
Tidsramme: 0, 3, 6, 9 and 12 months after therapy
|
0, 3, 6, 9 and 12 months after therapy
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Tidsramme: 0, 3, 6, 9 and 12 months after therapy
|
0, 3, 6, 9 and 12 months after therapy
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Nestor J. Lopez, DDS, University of Chile
- Hovedetterforsker: Antonio Quintero, DDS, University of Chile
- Studiestol: Carola Ibieta, DDS, University of Chile
- Studiestol: Carlos Y Valenzuela, DMS, PhD, University of Chile
- Studiestol: Lilian Jara, MsB, PhD, University of Chile
- Studiestol: Marcelo Llancaqueo, DMS, University of Chile
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Stomatognatiske sykdommer
- Munnsykdommer
- Insulinresistens
- Hyperinsulinisme
- Kardiovaskulære sykdommer
- Betennelse
- Metabolsk syndrom
- Periodontale sykdommer
- Anti-infeksjonsmidler
- Antibakterielle midler
- Antiprotozoale midler
- Antiparasittiske midler
- Metronidazol
- Amoksicillin
Andre studie-ID-numre
- FONDECYT 1061070
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .