Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Periodontal disease (PD) is an inflammatory, infectious and destructive condition of the tissues surrounding the teeth. However, even if bacteria are required to initiate periodontal disease, the immune response is responsible for most of the destruction of the periodontal tissues. Statins may be used to control the immune response to periodontal pathogens, a factor that has not yet been managed clinically and even less massively.

Recently it has been reported the pharmacological effectiveness of topically used statins. For periodontal disease, at least four well conducted clinical trials have been published using a topically statin formula for pocket irrigation in adult populations with chronic periodontal disease, observing surprising clinical results in all of them (with clinical and statistical significance) and no adverse reactions.

The purpose of the present study is asses the effectiveness of a medicated 2% atorvastatin dentifrice, as complement to non-surgical conventional periodontal treatment. Clinical examination will be made at the beginning and after one month of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad de los Andes, Chile; Universidad Los Andes, Chile
• Collaborator: Corporación de Fomento de la Producción, Chile
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

Inclusion Criteria:

• Patients included in the study will be those fully agreeing to participate by signing an informed consent, which has been submitted to and approved, together with the study protocol by the Ethics Committee of the Faculty of Dentistry of Universidad de Los Andes.

• The target population consists of 38 adult patients who consult the Service of Periodontology at the Universidad de Los Andes.

• The eligible population are those that meet the following criteria:

1. more than 35 years of age.

2. with at least 14 natural teeth in mouth (excluding third molars).

3. have some degree of periodontal disease.

Exclusion Criteria:

• Will be excluded those who:

1. Relate migration plans.

2. Presence of limiting disease for the understanding and execution of the study or are hospitalized.

3. Received periodontal treatment in the last year.

4. Completed antibiotic therapy or Non Steroidal Anti-inflammatory Drugs (NSAIDs) in the last two weeks.

5. Are using calcium channel blockers, phenytoin, cyclosporine or any associated drug that may affect gingival tissue.

6. Have autoimmune pathology.

7. Require antibiotic prophylaxis for periodontal treatment.

8. Patients requiring treatment with NSAIDs for postoperative pain control after the procedure done.

9. Patients on statin therapy for dyslipidemia.

10. Pregnant patients.