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

Chronic Periodontitis Clinical Trial

Official title:

Short-term Effect of 2% Atorvastatin Dentifrice as an Adjunct to Periodontal Therapy: A Randomized Double-blind Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929135
• Other study ID #: CORFO-13IDL1-18270
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2013
• Last updated: July 25, 2014
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2014
• Source: Universidad Los Andes, Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial 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.

Description:

An medicated 2% atorvastatin dentifrice (2 mg x every 0.1 ml of dentifrice) will be prepared for dental brushing. It will be used as a base a fluoride dentifrice, to which will be added atorvastatin in the prescribed amount. Medicated prototypes and placebos will be dosed in 5 ml syringes indicating each 0.5 ml measures to facilitate dispensing the product and ensure proper use. Thus, each syringe will be for 10 doses of toothpaste (10 brushings). 6 syringes will be provided to each patient, so that they have enough for a month of treatment, during which they will have to brush 2 times a day.

Sample size:

A clinical trial with two parallel groups (1:1) will be conducted, where there will be 2 groups of 19 patients each. The estimated sample size was based on the difference in attachment level achieved in the study Goodson et al (Goodson, Haffajee, Socransky, Kent, Teles, Hasturk, Bogren, Van Dyke, Wennstrom, Lindhe. Control of periodontal infections: A randomized controlled trial I. The primary outcome attachment gain and pocket depth reduction at Treated sites. J Clin Periodontol 2012, 39: 526-536), with a power of 90%, a significance level of 0.05 two-tailed.

Treatments and protocols:

Patients will be treated at the Department of Periodontology of Health Care Center, Universidad de Los Andes in San Bernardo, Santiago, Chile.

The two groups will undergo non-surgical periodontal therapy consisting of scaling and root planning of all tooth groups.

Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice that will be provided, 2 times a day for two minutes each time. Then they will be told to spit the dentifrice excesses during 30 seconds, but not to rinse their teeth, or consume liquids or solid foods for at least 30 minutes. A group of 19 patients will receive the medicated 2%atorvastatin dentifrice while the other group of 19 patients will receive dentifrice without the drug to act as a placebo.

The record of the application of statins will be done by a professor at the Faculty of Dentistry, before periodontal clinical evaluation, in order not to influence the researcher.

The allocation to each group will be random and there will be a sequence concealment.

Analysis Plan:

Continuous variables will be described by measures of central tendency and dispersion. Dichotomous variables will be tabulated and described by absolute frequencies and percentages according to each group. The delta of the outcome variables will be calculated as the difference between measurements before and after intervention. Multiple linear regression models will be used to compare the deltas of outcome variables after adjusting for gender, diabetes and tobacco use. A p value of <0.05 is considered statistically significant. The analysis will be performed with Stata software (version 12; Stata Corporation, Lakeway Drive, College Station, Texas, USA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Medicated 2% atorvastatin dentifrice
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-medicated dentifrice
Non surgical periodontal therapy accompanied by non medicated dentifrice 2 times a day for two minutes each time, for 30 days.

Locations

Country	Name	City	State
Chile	Centro de Salud Universidad de los Andes, San Bernardo	Santiago	Región Metropolitana
Chile	CIBRO Universidad de los Andes	Santiago	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Los Andes, Chile	Corporación de Fomento de la Producción, Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Periodontal Inflammation Surface Area (PISA)	PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing.; Change in PISA: baseline measure minus 1 month later measure.	baseline and 1 month later of intervention	No
Secondary	Change in Mean Pocket Depth (PD)	The PD will be defined as the distance from the free gingival margin to the bottom of the pocket. For each tooth will be conducted periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal, mesiolingual / palatal, mediolingual / palatal, distolingual/ palatal).; Change in mean PD: baseline measure minus 1 month later measure.	baseline and 1 month later	No
Secondary	Change in Clinical Attachment Level (CAL)	The Clinical Attachment Level (CAL) is defined as the distance from the cement-enamel junction to the fornix of the pocket. For each tooth will be performed periodontal probing at 6 sites (mesiobuccal, mediobuccal, distobuccal mesiolingual / palatal mediolingual / distolingual palatal / lingual).; Change in CAL: baseline measure minus 1 month later measure.	baseline and 1 month after intervention	No
Secondary	Change in Bleeding on Probing Index (BOP)	The bleeding on probing index (BOP) will be determined by assigning + to the presence of bleeding on vestibular / palatine probing of the tooth examined and with a sign - the abscence. Later the + signs will be summed and divided by the number of sites examined.; Change in BOP: baseline measure minus 1 month later measure.	baseline and 1 month after intervention	No
Secondary	Change in Gingival Index	Determined as score assigned to each site evaluated respect to clinical criteria as followed: Score Criteria: 0. No inflammation; Mild inflammation, slight change in color, slight edema, no bleeding on probing.; Moderate inflammation, moderate glazing, redness, bleeding on probing.; Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.; Then was calculated a score for each sextant summed the score and divided by the number of examined sites. Later was summed each sextant score and divided by sextant evaluated.; The change was calculated as baseline measure minus 1 month later measure.	baseline and 1 month after intervention	No