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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04836078
Other study ID # Simvastatin in periodontitis
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 10, 2020
Est. completion date October 10, 2020

Study information

Verified date April 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 10, 2020
Est. primary completion date August 10, 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Assiut University Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pocket depth Will be measured in millimetre Before the beginning of study
Primary Pocket depth Will be measured in millimetre By the end of study after 6 months of 6 months
Primary Clinical attachment loss Will be measured in millimetre Before beginning of the study
Primary Clinical attachment loss Will be measured in millimetre By the end of study after 6 months of 6 months
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