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

Primary Purpose

Adult Periodontitis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
Dr. D. Y. Patil Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Periodontitis focused on measuring Intervention Study, Rosuvastatin, Periodontitis

Eligibility Criteria

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

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.

Sites / Locations

  • Sukhada Deo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ROSUVASTATIN

placebo

Arm Description

1.2% Rosuvastatin Gel. Insertion in infrabony defects once

No intervention used on control site

Outcomes

Primary Outcome Measures

Bone fill
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

Probing depth
Clinical parameters- Reduction in this parameter is desired at the end of 6 months
relative attachment level
Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment
plaque index
Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health
bleeding index
Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health

Full Information

First Posted
August 17, 2018
Last Updated
September 18, 2018
Sponsor
Dr. D. Y. Patil Dental College & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03677297
Brief Title
"Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects"
Official Title
Comparative Evaluation of Treatment Of Infrabony Defects With and Without 1.2% Rosuvastatin Gel: In-Vivo Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 28, 2016 (Actual)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. D. Y. Patil Dental College & Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Periodontitis
Keywords
Intervention Study, Rosuvastatin, Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ROSUVASTATIN
Arm Type
Experimental
Arm Description
1.2% Rosuvastatin Gel. Insertion in infrabony defects once
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
No intervention used on control site
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
No intervention used on Control site
Intervention Description
Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel
Primary Outcome Measure Information:
Title
Bone fill
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Probing depth
Description
Clinical parameters- Reduction in this parameter is desired at the end of 6 months
Time Frame
6 months
Title
relative attachment level
Description
Clinical parameters- Reduction in this parameter at the end of 6 months shows gain in attachment
Time Frame
6 months
Title
plaque index
Description
Clinical parameters- Reduction in plaque index at the end of 6 months shows improvement in gingival health
Time Frame
6 months
Title
bleeding index
Description
Clinical parameters- Reduction in bleeding index at the end of 6 months shows improvement in gingival health
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sukhada D Deo, BDS
Organizational Affiliation
Dr. D. Y. Patil Dental College & Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sukhada Deo
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411018
Country
India

12. IPD Sharing Statement

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

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