Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Intervention: Medicated 2% atorvastatin dentifrice; Non-medicated dentifrice
Intervention description: Non surgical periodontal therapy accompanied by medicated 2% atorvastatin dentifrice (20 mg per ml) 2 times a day for two minutes each time, for 30; Non surgical periodontal therapy accompanied by non medicated dentifrice 2 times a day for two minutes each time, for 30 days.
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Periodontal Disease; Chronic Periodontitis; Atorvastatin; Statins; Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors; Dentifrice

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.
    

Eligibility 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.