Role of Simvastatin Microsponges in Treatment of Periodontitis
NCT ID: NCT04836078
Last Updated: 2021-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
24 participants
INTERVENTIONAL
2020-02-10
2020-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Plain chitosan gel group
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 .
open flap subgingival debridement
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.
Subgingival injection of chitosan 2% gel
Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly
Chitosan gels containing free Simvastatin
Will be injected subgingivally with simvastatin microsponges dispersed into chitosan 2% gel. .
open flap subgingival debridement
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.
Subgingival injection of chitosan 2% gel
Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly
Chitosan gels containing Simvastatin microsponges
This group will be injected subgingivally with free simvastatin dispersed into chitosan 2% gel containing .
open flap subgingival debridement
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.
Subgingival injection of chitosan 2% gel
Group (III); injected subgingivally with placebo chitosan 2% gel weekly
Interventions
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open flap subgingival debridement
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.
Subgingival injection of chitosan 2% gel
Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly
Subgingival injection of chitosan 2% gel
Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly
Subgingival injection of chitosan 2% gel
Group (III); injected subgingivally with placebo chitosan 2% gel weekly
Eligibility Criteria
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Inclusion Criteria
* patients with normal lipid profile
* nonsmokers
* patients free from any systemic disorders
* committed patients to complete the treatment with follow-ups.
Exclusion Criteria
* patients taking lipid lowering drugs
* smokers
* pregnant
* Lactating women women, patients with mental or psychological illness and medically compromised patients.
30 Years
50 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Mortada
Lecturer at the Department of Periodontology and Oral Implantology , Faculty of Dentistry , Assiut University, Egypt
Locations
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Assiut University
Asyut, , Egypt
Countries
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Other Identifiers
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Simvastatin in periodontitis
Identifier Type: -
Identifier Source: org_study_id
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