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

Effect of non-surgical periodontal treatment associated with 1.2% simvastatin locally delivered in patients with chronic periodontitis and hyperlipidemia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-3rjby9
Enrollment
Unknown
Registered
2017-07-12
Start date
2017-06-15
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe periodontitis

Interventions

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
Drug
Procedure/surgery
E06.721.189.350

Sponsors

Universidade Federal do Rio Grande do Sul
Lead Sponsor
Universidade Federal do Rio Grande do Sul
Collaborator

Eligibility

Age
30 Years to 60 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Contacts

Public ContactCassiano;Francisco Wilker Rosing;Muniz

Universidade Federal do Rio Grande do Sul;Universidade Federal do Rio Grande do Sul

ckrosing@hotmail.com;wilkermustafa@gmail.com+55(51)33085318;+55(51)33085318

Outcome results

None listed

Source: REBEC (via WHO ICTRP)