The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

Phase 2

Completed

• Conditions: Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration
• Interventions: Drug: Lovastatin gel; Drug: Placebo

• Registration Number: NCT03178526
• Lead Sponsor: Islamic Azad University, Tehran

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.

Study Timeline

• Study Start: 2015-12-24
• Primary Completion: 2016-01-13
• Study Completion: 2016-02-13
• Study First Submitted: 2017-06-05
• Study First Submitted QC: 2017-06-06
• Study First Posted: 2017-06-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levostatin gel	Lovastatin gel	levostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe
placebo gel	Placebo	placebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe

Primary Outcome Measures

Name	Time	Method
Bone defect fill	Three months	radiographic analysis for bone defect