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Completed

NCT Number: NCT04836078

Role of Simvastatin Microsponges in Treatment of Periodontitis

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Assiut University

Asyut, 71111111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

open flap subgingival debridement

Procedure

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

Procedure

Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly

Primary outcomes

  1. Pocket depth

    Time frame: Before the beginning of study

    Will be measured in millimetre

  2. Pocket depth

    Time frame: By the end of study after 6 months of 6 months

    Will be measured in millimetre

  3. Clinical attachment loss

    Time frame: Before beginning of the study

    Will be measured in millimetre

  4. Clinical attachment loss

    Time frame: By the end of study after 6 months of 6 months

    Will be measured in millimetre

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Performance of Simvastatin Microsponges as a Local Treatment for Chronic Periodontitis - Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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