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The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT03178526
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Amirhossein Farahmand, 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.


Condition or disease Intervention/treatment Phase
Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration Drug: Lovastatin gel Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis Randomized Controlled Trial Split-mouth
Actual Study Start Date : December 24, 2015
Actual Primary Completion Date : January 13, 2016
Actual Study Completion Date : February 13, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lovastatin

Arm Intervention/treatment
Active Comparator: levostatin gel
levostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe
Drug: Lovastatin gel
Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe
Other Name: Group A

Placebo Comparator: placebo gel
placebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe
Drug: Placebo
placebo gel




Primary Outcome Measures :
  1. Bone defect fill [ Time Frame: Three months ]
    radiographic analysis for bone defect



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


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Responsible Party: Amirhossein Farahmand, The effect of lovastatin gel in the treatment of chronic periodontitis a randomized controlled trial with split-mouth, Islamic Azad University, Tehran
ClinicalTrials.gov Identifier: NCT03178526     History of Changes
Other Study ID Numbers: 25187
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Periodontitis
Alveolar Bone Loss
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Insulin
Lovastatin
L 647318
Dihydromevinolin
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors