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"Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects"

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ClinicalTrials.gov Identifier: NCT03677297
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
DR. SUKHADA DEO, Dr. D. Y. Patil Dental College & Hospital

Brief Summary:
Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.

Condition or disease Intervention/treatment Phase
Adult Periodontitis Drug: Rosuvastatin Phase 4

Detailed Description:

Source from where the patients will be selected:

10 patients with chronic periodontitis having two or more infrabony defects will be selected from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune - 18.

A detailed clinical examination, case history and written consent will be obtained from all the participants.

Before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed envelopes (SNOSE) randomization into control and test sites. The control site will be treated with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2% Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at 4 weeks, 3 and 6 month after surgery.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study
Actual Study Start Date : January 28, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ROSUVASTATIN
1.2% Rosuvastatin Gel. Insertion in infrabony defects once
Drug: Rosuvastatin
Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel
Other Name: No intervention used on Control site

Placebo Comparator: placebo
No intervention used on control site
Drug: Rosuvastatin
Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel
Other Name: No intervention used on Control site




Primary Outcome Measures :
  1. Bone fill [ Time Frame: 6 months ]

    Radiographic parameter measuring distance from cemento-enamel junction to the base of the defect.

    Difference in the measurement at the end of 6 months shows the amount of bone fill



Secondary Outcome Measures :
  1. Probing depth [ Time Frame: 6 months ]
    Clinical parameters- Reduction in this parameter is desired at the end of 6 months

  2. relative attachment level [ Time Frame: 6 months ]
    Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment

  3. plaque index [ Time Frame: 6 months ]
    Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health

  4. bleeding index [ Time Frame: 6 months ]
    Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age group between 30-50 years
  • Probing pocket depth ≥ 5mm following initial therapy.
  • Suitable interproximal angular infrabony defects of ≥3mm.
  • Involved teeth should be vital and asymptomatic.
  • Systemically healthy patients.
  • Patients who demonstrate acceptable oral hygiene prior to access flap surgery.
  • Patients agreed to sign informed consent and willing to return for the follow up visits.

Exclusion Criteria:

  • Systemic statin therapy
  • Known or suspected allergy to the statin group
  • Allergy to sulfur containing drugs
  • History of aggressive periodontitis.
  • Presence of gingival recession at the surgical site.
  • Mobility of study teeth ≥ grade I.
  • Use of tobacco in any form.
  • Pregnant and lactating women.
  • patients who have received any anti-inflammatory drugs and antibiotics in the previous six months.
  • H/O osteoporosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677297


Locations
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India
Sukhada Deo
Pune, Maharashtra, India, 411018
Sponsors and Collaborators
Dr. D. Y. Patil Dental College & Hospital
Investigators
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Principal Investigator: Sukhada D Deo, BDS Dr. D. Y. Patil Dental College & Hospital

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Responsible Party: DR. SUKHADA DEO, Principal investigator, Dr. D. Y. Patil Dental College & Hospital
ClinicalTrials.gov Identifier: NCT03677297     History of Changes
Other Study ID Numbers: DPU/R & R (D)/ 98(10)/ 16
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by DR. SUKHADA DEO, Dr. D. Y. Patil Dental College & Hospital:
Intervention Study
Rosuvastatin
Periodontitis

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors