- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01046435
Effects of Periodontal Therapy on Systemic Inflammation
Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Santiago, Chile
- Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: 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
Andre navne:
Two placebos 3 times a day for 7 days
Andre navne:
|
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Eksperimentel: 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 navne:
Two placebos 3 times a day for 7 days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Tidsramme: 0, 3, 6, 9 and 12 months after therapy
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0, 3, 6, 9 and 12 months after therapy
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nestor J. Lopez, DDS, University of Chile
- Ledende efterforsker: 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
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Stomatognatiske sygdomme
- Mundsygdomme
- Insulin resistens
- Hyperinsulinisme
- Hjerte-kar-sygdomme
- Betændelse
- Metabolisk syndrom
- Periodontale sygdomme
- Anti-infektionsmidler
- Antibakterielle midler
- Antiprotozoale midler
- Antiparasitære midler
- Metronidazol
- Amoxicillin
Andre undersøgelses-id-numre
- FONDECYT 1061070
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