The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

NCT ID: NCT03178526

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-24
• Study Completion Date: 2016-02-13

Brief Summary

Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis.

Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3 mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular molars were selected for teh study.

Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments were performed at baseline and after 6 months. At one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for statistic analysis Spss 23.( P<0.05) was considered significant.

Detailed Description

Statins are an important group of hypolipidemic drugs dat are able to modulate inflammation and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are non to inhibit osteoclastic bone resorption and has been proposed to has osteostimulative properties.

Conditions

Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

levostatin gel

levostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe

Group Type: ACTIVE_COMPARATOR

Lovastatin gel

Intervention Type: DRUG

Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe

placebo gel

placebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo gel

Interventions

Lovastatin gel

Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe

Intervention Type: DRUG

Placebo

placebo gel

Intervention Type: DRUG

Other Intervention Names

Group A

Eligibility Criteria

Inclusion Criteria

24 patients wif periodontitis chronic and TEMPhas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and CAL greater than 3 mm in at least one of the surfaces of the teeth, the X-ray bars from both sides of the molar regions jaw bottom, from CEJ and alveolar crest was more than 3 mm, were selected

Exclusion Criteria

1. systemic disease

2. pregnancy or breastfeeding

3. allergy drug used

4. smoking

5. medication 6. not willing to consent to participate in the study

7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Islamic Azad University, Sanandaj

OTHER

Sponsor Role: lead

Responsible Party

Amirhossein Farahmand

The effect of lovastatin gel in the treatment of chronic periodontitis a randomized controlled trial with split-mouth

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

25187

Identifier Type: -

Identifier Source: org_study_id