Chronic PeriodontitisPhase 2NCT01929135
Short-term Effect of 2% Atorvastatin Dentifrice in Periodontal Status.
A Phase 2 study testing Medicated 2% atorvastatin dentifrice and Non-medicated dentifrice in people with Chronic Periodontitis, run by Universidad de los Andes, Chile at 2 sites in Chile.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Medicated 2% atorvastatin dentifrice and Non-medicated dentifrice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesChile
- Study dates
- May 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Centro de Salud Universidad de los Andes, San Bernardo
Santiago, Santiago Metropolitan
CIBRO Universidad de los Andes
Santiago, Santiago Metropolitan
About this study
Official title: Short-term Effect of 2% Atorvastatin Dentifrice as an Adjunct to Periodontal Therapy: A Randomized Double-blind Clinical Trial.
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.
Read the detailed 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).
- Conditions
- Chronic Periodontitis
- Being tested
- Medicated 2% atorvastatin dentifrice, Non-medicated dentifrice
- Keywords
- Periodontal Disease, Chronic Periodontitis, Atorvastatin, Statins, Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors, Dentifrice
- Medical subject headings
- Chronic Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicated 2% atorvastatin dentifriceDrug
Also called medicated dentifrice with atorvastatin
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 dentifriceDrug
Also called Placebo dentifrice
Non surgical periodontal therapy accompanied by non medicated dentifrice 2 times a day for two minutes each time, for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Non-medicated dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 1 month later of intervention
Secondary outcomes (4)
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.
Measured: baseline and 1 month later
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.
Measured: baseline and 1 month after intervention
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.
Measured: baseline and 1 month after intervention
Change in Gingival Index
Determined as score assigned to each site evaluated respect to clinical criteria as followed:
Score Criteria:
- 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.
Measured: baseline and 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Corporación de Fomento de la Producción, Chile
- Responsible party
- Principal investigator, Dr. David Rosenberg, Universidad de los Andes, Chile
- Investigators
- David R Rosenberg, DDS, MDS, Principal investigator, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929135
- Sponsor's protocol ID
- CORFO-13IDL1-18270
- Status last verified
- Jul 2014
- First submitted
- 18 Aug 2013
- Last updated
- 28 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of 2% Atorvastatin Dentifrice as an Adjunct to Periodontal Therapy: A Randomized Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT01929135
- Acronym / sponsor ID
- CORFO-13IDL1-18270
- Conditions
- Chronic Periodontitis
- Keywords
- Periodontal Disease, Chronic Periodontitis, Atorvastatin, Statins, Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors, Dentifrice
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Corporación de Fomento de la Producción, Chile
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 28 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicated 2% atorvastatin dentifrice | Experimental | Drug: Medicated 2% atorvastatin dentifriceA 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. |
| Non-medicated dentifrice | Placebo comparator | Drug: Non-medicated dentifriceA 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (11 listed)
- Will be excluded those who:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicated 2% atorvastatin dentifriceAlso: medicated dentifrice with atorvastatinNon surgical periodontal therapy accompanied by medicated 2% atorvastatin dentifrice (20 mg per ml) 2 times a day for two minutes each time, for 30 | Drug | Medicated 2% atorvastatin dentifrice |
| Non-medicated dentifriceAlso: Placebo dentifriceNon surgical periodontal therapy accompanied by non medicated dentifrice 2 times a day for two minutes each time, for 30 days. | Drug | Non-medicated dentifrice |
Primary outcome
Change in Periodontal Inflammation Surface Area (PISA)
Time frame: baseline and 1 month later of intervention
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.
4 secondary outcomes
Change in Mean Pocket Depth (PD)
Time frame: baseline and 1 month later
Change in Clinical Attachment Level (CAL)
Time frame: baseline and 1 month after intervention
Change in Bleeding on Probing Index (BOP)
Time frame: baseline and 1 month after intervention
Change in Gingival Index
Time frame: baseline and 1 month after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Rosenberg, DDS, MDS principal investigator
Universidad de los Andes, Chile
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medicated 2% atorvastatin dentifrice and Non-medicated dentifrice in people with Chronic Periodontitis, run by Universidad de los Andes, Chile at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Periodontal Inflammation Surface Area (PISA) (time frame: baseline and 1 month later of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.