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

NCT01929135 | Completed Phase 2 Results DMC

• 1 other identifier: CORFO-13IDL1-18270
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Chronic Periodontitis

Keywords

Periodontal Disease; Chronic Periodontitis; Atorvastatin; Statins; Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors; Dentifrice

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Mean Pocket Depth (PD)

  baseline and 1 month later

• Change in Clinical Attachment Level (CAL)

  baseline and 1 month after intervention

• Change in Bleeding on Probing Index (BOP)

  baseline and 1 month after intervention

• Change in Gingival Index

  baseline and 1 month after intervention

Study Arms (2)

Medicated 2% atorvastatin dentifrice

EXPERIMENTAL

A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time, for 30 days.

Drug: Medicated 2% atorvastatin dentifrice

Non-medicated dentifrice

PLACEBO COMPARATOR

A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.

Drug: Non-medicated dentifrice

Interventions

Medicated 2% atorvastatin dentifrice DRUG

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

Also known as: medicated dentifrice with atorvastatin

Medicated 2% atorvastatin dentifrice

Non-medicated dentifrice DRUG

Non surgical periodontal therapy accompanied by non medicated dentifrice 2 times a day for two minutes each time, for 30 days.

Also known as: Placebo dentifrice

Non-medicated dentifrice

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• more than 35 years of age.
• with at least 14 natural teeth in mouth (excluding third molars).
• have some degree of periodontal disease.

You may not qualify if:

• Will be excluded those who:
• Relate migration plans.
• Presence of limiting disease for the understanding and execution of the study or are hospitalized.
• Received periodontal treatment in the last year.
• Completed antibiotic therapy or Non Steroidal Anti-inflammatory Drugs (NSAIDs) in the last two weeks.
• Are using calcium channel blockers, phenytoin, cyclosporine or any associated drug that may affect gingival tissue.
• Have autoimmune pathology.
• Require antibiotic prophylaxis for periodontal treatment.
• Patients requiring treatment with NSAIDs for postoperative pain control after the procedure done.
• Patients on statin therapy for dyslipidemia.
• Pregnant patients.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Corporación de Fomento de la Producción, Chile: collaborator

Study Sites (2)

Centro de Salud Universidad de los Andes, San Bernardo

Santiago, Santiago Metropolitan, Chile

Location

CIBRO Universidad de los Andes

Santiago, Santiago Metropolitan, Chile

Location

MeSH Terms

Conditions

Chronic Periodontitis; Periodontal Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Periodontitis; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Dra. Catherine Andrade
• Organization: Universidad de los Andes

catherine.perio@gmail.com

056-972862308

Study Officials

• David R Rosenberg, DDS, MDS

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of the Faculty of Dentistry

Study Record Dates

• First Submitted: August 18, 2013
• First Posted: August 27, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 28, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-07

Locations

CL (2)