search
Back to results

The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

Primary Purpose

Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Lovastatin gel
Placebo
Sponsored by
Islamic Azad University, Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    levostatin gel

    placebo gel

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Bone defect fill
    radiographic analysis for bone defect

    Secondary Outcome Measures

    Full Information

    First Posted
    June 5, 2017
    Last Updated
    July 2, 2019
    Sponsor
    Islamic Azad University, Tehran
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03178526
    Brief Title
    The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis
    Official Title
    The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis Randomized Controlled Trial Split-mouth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 24, 2015 (Actual)
    Primary Completion Date
    January 13, 2016 (Actual)
    Study Completion Date
    February 13, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Islamic Azad University, Tehran

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    levostatin gel
    Arm Type
    Active Comparator
    Arm Description
    levostatin gel 1.2% topical gel was put into teh periodontal pocket using an insulin syringe
    Arm Title
    placebo gel
    Arm Type
    Placebo Comparator
    Arm Description
    placebo gel 1.2% topical gel was put into the periodontal pocket using an insulin syringe
    Intervention Type
    Drug
    Intervention Name(s)
    Lovastatin gel
    Other Intervention Name(s)
    Group A
    Intervention Description
    Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    placebo gel
    Primary Outcome Measure Information:
    Title
    Bone defect fill
    Description
    radiographic analysis for bone defect
    Time Frame
    Three months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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: systemic disease pregnancy or breastfeeding allergy drug used smoking 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

    We'll reach out to this number within 24 hrs