- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01046435
Effects of Periodontal Therapy on Systemic Inflammation
Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Santiago, Chili
- Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Supragingival scaling plus placebo
Plaque control instructions, supra gingival scaling and two placebos
|
Metronidazole 250 mg three times a day per 7 days
Autres noms:
Two placebos 3 times a day for 7 days
Autres noms:
|
|
Expérimental: 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
Autres noms:
Two placebos 3 times a day for 7 days
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
Délai: 0, 3, 6, 9 and 12 months after therapy
|
0, 3, 6, 9 and 12 months after therapy
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
Délai: 0, 3, 6, 9 and 12 months after therapy
|
0, 3, 6, 9 and 12 months after therapy
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Nestor J. Lopez, DDS, University of Chile
- Chercheur principal: Antonio Quintero, DDS, University of Chile
- Chaise d'étude: Carola Ibieta, DDS, University of Chile
- Chaise d'étude: Carlos Y Valenzuela, DMS, PhD, University of Chile
- Chaise d'étude: Lilian Jara, MsB, PhD, University of Chile
- Chaise d'étude: Marcelo Llancaqueo, DMS, University of Chile
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies stomatognathiques
- Maladies de la bouche
- Résistance à l'insuline
- Hyperinsulinisme
- Maladies cardiovasculaires
- Inflammation
- Syndrome métabolique
- Maladies parodontales
- Agents anti-infectieux
- Agents antibactériens
- Agents antiprotozoaires
- Agents antiparasitaires
- Métronidazole
- Amoxicilline
Autres numéros d'identification d'étude
- FONDECYT 1061070
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