NCT04836078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

March 25, 2021

Last Update Submit

April 5, 2021

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (4)

  • Pocket depth

    Will be measured in millimetre

    Before the beginning of study

  • Pocket depth

    Will be measured in millimetre

    By the end of study after 6 months of 6 months

  • Clinical attachment loss

    Will be measured in millimetre

    Before beginning of the study

  • Clinical attachment loss

    Will be measured in millimetre

    By the end of study after 6 months of 6 months

Study Arms (3)

Plain chitosan gel group

PLACEBO COMPARATOR

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 .

Procedure: open flap subgingival debridementProcedure: Subgingival injection of chitosan 2% gel

Chitosan gels containing free Simvastatin

ACTIVE COMPARATOR

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

Procedure: open flap subgingival debridementProcedure: Subgingival injection of chitosan 2% gel

Chitosan gels containing Simvastatin microsponges

EXPERIMENTAL

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

Procedure: open flap subgingival debridementProcedure: Subgingival injection of chitosan 2% gel

Interventions

open flap subgingival debridementPROCEDURE

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.

Chitosan gels containing Simvastatin microspongesChitosan gels containing free SimvastatinPlain chitosan gel group
Subgingival injection of chitosan 2% gelPROCEDURE

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

Plain chitosan gel group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71111111, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Gels

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer at the Department of Periodontology and Oral Implantology , Faculty of Dentistry , Assiut University, Egypt

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 8, 2021

Study Start

February 10, 2020

Primary Completion

August 10, 2020

Study Completion

October 10, 2020

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)