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Role of Simvastatin Microsponges in Treatment of Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
open flap subgingival debridement
Subgingival injection of chitosan 2% gel
Subgingival injection of chitosan 2% gel
Subgingival injection of chitosan 2% gel
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with chronic periodontitis with minimum two sites of pocket depth > 5 mm
  • patients with normal lipid profile
  • nonsmokers
  • patients free from any systemic disorders
  • committed patients to complete the treatment with follow-ups.

Exclusion Criteria:

  • patients with hyperlipidemia
  • patients taking lipid lowering drugs
  • smokers
  • pregnant
  • Lactating women women, patients with mental or psychological illness and medically compromised patients.

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Plain chitosan gel group

Chitosan gels containing free Simvastatin

Chitosan gels containing Simvastatin microsponges

Arm Description

After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel .

Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .

This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .

Outcomes

Primary Outcome Measures

Pocket depth
Will be measured in millimetre
Pocket depth
Will be measured in millimetre
Clinical attachment loss
Will be measured in millimetre
Clinical attachment loss
Will be measured in millimetre

Secondary Outcome Measures

Full Information

First Posted
March 25, 2021
Last Updated
April 5, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04836078
Brief Title
Role of Simvastatin Microsponges in Treatment of Periodontitis
Official Title
Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
October 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
the aim of our study is to enhance the dissolution and subsequently the local penetration of the drug through the sulcus in addition to controlling the drug release so that, the drug could be potentially absorbed.
Detailed Description
Patients will be divided randomly into three groups: Group (I);will be treated with subgingival debridement and subgengival injection of chitosan 2% gel containing a microsponges formulated (SV), Group (II); will be treated with subgingival debridement and subgingival injection of chitosan 2% gel containing free (SV) and Group (III); will be treated by subgingival debridement and placebo gel injected subgingivally. Pocket depth and clinical attachment loss bone gain were recorded preoperative and six months postoperative for all groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plain chitosan gel group
Arm Type
Placebo Comparator
Arm Description
After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement . Randomization will be performed and concealment from the assessors. For root conditioning purpose, Group (I) ; will be injected subgingivally with chitosan 2% gel .
Arm Title
Chitosan gels containing free Simvastatin
Arm Type
Active Comparator
Arm Description
Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .
Arm Title
Chitosan gels containing Simvastatin microsponges
Arm Type
Experimental
Arm Description
This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .
Intervention Type
Procedure
Intervention Name(s)
open flap subgingival debridement
Intervention Description
After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors.
Intervention Type
Procedure
Intervention Name(s)
Subgingival injection of chitosan 2% gel
Intervention Description
Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly
Intervention Type
Procedure
Intervention Name(s)
Subgingival injection of chitosan 2% gel
Intervention Description
Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly
Intervention Type
Procedure
Intervention Name(s)
Subgingival injection of chitosan 2% gel
Intervention Description
Group (III); injected subgingivally with placebo chitosan 2% gel weekly
Primary Outcome Measure Information:
Title
Pocket depth
Description
Will be measured in millimetre
Time Frame
Before the beginning of study
Title
Pocket depth
Description
Will be measured in millimetre
Time Frame
By the end of study after 6 months of 6 months
Title
Clinical attachment loss
Description
Will be measured in millimetre
Time Frame
Before beginning of the study
Title
Clinical attachment loss
Description
Will be measured in millimetre
Time Frame
By the end of study after 6 months of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with chronic periodontitis with minimum two sites of pocket depth > 5 mm patients with normal lipid profile nonsmokers patients free from any systemic disorders committed patients to complete the treatment with follow-ups. Exclusion Criteria: patients with hyperlipidemia patients taking lipid lowering drugs smokers pregnant Lactating women women, patients with mental or psychological illness and medically compromised patients.
Facility Information:
Facility Name
Assiut University
City
Assuit
ZIP/Postal Code
71111111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Role of Simvastatin Microsponges in Treatment of Periodontitis

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