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Effects of Periodontal Therapy on Systemic Inflammation
Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Santiago, Chili
- Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: Supragingival scaling plus placebo
Plaque control instructions, supra gingival scaling and two placebos
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Metronidazole 250 mg three times a day per 7 days
Andere namen:
Two placebos 3 times a day for 7 days
Andere namen:
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Experimenteel: 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
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Metronidazole 250 mg three times a day per 7 days
Andere namen:
Two placebos 3 times a day for 7 days
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
Tijdsspanne: 0, 3, 6, 9 and 12 months after therapy
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0, 3, 6, 9 and 12 months after therapy
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Tijdsspanne: 0, 3, 6, 9 and 12 months after therapy
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0, 3, 6, 9 and 12 months after therapy
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nestor J. Lopez, DDS, University of Chile
- Hoofdonderzoeker: Antonio Quintero, DDS, University of Chile
- Studie stoel: Carola Ibieta, DDS, University of Chile
- Studie stoel: Carlos Y Valenzuela, DMS, PhD, University of Chile
- Studie stoel: Lilian Jara, MsB, PhD, University of Chile
- Studie stoel: Marcelo Llancaqueo, DMS, University of Chile
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Glucosemetabolismestoornissen
- Metabole ziekten
- Stomatognatische ziekten
- Mondziekten
- Insuline-resistentie
- Hyperinsulinisme
- Hart-en vaatziekten
- Ontsteking
- Metaboolsyndroom
- Parodontale aandoeningen
- Anti-infectieuze middelen
- Antibacteriële middelen
- Antiprotozoaire middelen
- Antiparasitaire middelen
- Metronidazol
- Amoxicilline
Andere studie-ID-nummers
- FONDECYT 1061070
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