Gum treatment associated with application of simvastatin gel in patients with high levels os cholesterol

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-3rjby9
• Date of registration: 12/07/2017
• Prospective Registration: No
• Primary sponsor: Universidade Federal do Rio Grande do Sul
• Public title: Gum treatment associated with application of simvastatin gel in patients with high levels os cholesterol
• Scientific title: Effect of non-surgical periodontal treatment associated with 1.2% simvastatin locally delivered in patients with chronic periodontitis and hyperlipidemia
• Date of first enrolment: 15/06/2017
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-3rjby9
• Study type: Intervention
• Study design: Efficacy, clinical trial, randomized, in parallel, triple-blind, with two arms, phase 4
• Phase: 4

Countries of recruitment

Brazil

Contacts

• Name: Cassiano Kuchenbecker Rosing
• Affiliation: Universidade Federal do Rio Grande do Sul

• Name: Francisco Wilker Mustafa Gomes Muniz
• Affiliation: Universidade Federal do Rio Grande do Sul

Key inclusion & exclusion criteria

Inclusion criteria: Man and women between 30 to 60 years of age; Availability to participate in all study phases; Good general health; At least 10 natural teeth, except for the third molars; Diagnosis of severe periodontitis according to Eke et al. (2012), which is at least one interproximal site with probing depth >5mm and clinical attachment loss >6mm in at least two interproximal sites and in different teeth; At baseline, report the use of any statin for at least 3 months;
Exclusion criteria: Presence of orthodontic bands any type of fixed orthodontic appliance; Tumor (s) of soft or hard tissues of the oral cavity; Use of antibiotics 3 months prior to study begging; Pregnant or lactating women; Diagnosis or treatment for diabetes and renal chronic diseases, or any history of stroke; Need to use antimicrobial chemoprophylaxis to receive dental treatment; Had received periodontal treatment in the last 6 months; Current smokers or former smokers in less than 2 years; Body mass index >30 kg/m2.


Age minimum: 30Y
Age maximum: 60Y
Gender: -

Health Condition(s) or Problem(s) studied

C18.452.584.500.500

C07.465.714.533

Severe periodontitis; Hyperlipidemia

Intervention(s)

All patients will receive non-surgical periodontal treatment, which consist of supragingival scaling planing and scaling and root planing (SRP) (also known as dental scaling). Furthermore, in the end of each SRP session, all patients will receive locally delivered gel of simvastatin 1.2% or a placebo gel, composed of carboxymethylcellulose vehicle. During all trial, the gel will be locally delivered only onnce in the periodontal pocket. Totally, 40 patients will be included in this randomized clinical trial in parallel, which is 20 patients for each experimental group.

Drug

E06.721.189.350

Procedure/surgery

Primary Outcome(s)

The Clinical attachment level (CAL) will be measured in 6 sites per tooth. All tooth will be evaluated, except for third molars. This measurement comprised the distance, in milimeters, from the bottom of the periodontal pocket until the cemento-ennamel juntion. The changes the occur from the baseline appointment to the 3, 6, 9, 12, and 24-months appoitment in will recorded. Mean and standar deviation from the CAL change will be reported to each patient and each experimental group.

Secondary Outcome(s)

Similarly to clinical attachment level, the pocket depth and bleeding on probing will be measured in 6 sites per tooth. Regarding pocket depth, the mean change, in milimiter, of the distance of the gingival margin until the bottom of the periodontal pocket will be determined to each patient/each experimental group. Regarding bleeding on probing, the mean change in the percentage of sites with subgingival bleeding will be determined to each patient/each experimental group. To both parameters, the changes between the baseline appoitment and the re-call appoitments (3, 6, 9, 12, and 24 months) will be considered. Furthermore, the alveolar bone level changes, in milimeters, assessed by pradonized periapical radiographs, will be considered. The comparisons will be performed between the initial radiography and the re-call radiographies (6, 12, and 24 months) will be considered. Changes in the total cholesterol, HDL, LDL e triglycerides will be also determined by the comparison of the initial examination and the follow-up examinations (3, 6, 12, and 24 months). To all secondary outcomes, the values will be reported in mean and standard deviation to each pacient/experimental group.

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior

Secondary Sponsor(s)

Universidade Federal do Rio Grande do Sul