NCT05583643

Brief Summary

Periodontitis is a destructive chronic inflammatory disease characterized by periodontium damage and pocket formation between the tooth and the gingival margin resulting in ultimate tooth loss. Various topical anti-inflammatory drugs were used to treat inflammation in periodontitis. Introducing atorvastatin as a novel remedy for periodontitis treatment necessitates developing a syringeable modified delivery system capable of targeting inflammation within the periodontal pockets.

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 phase_1

Timeline
Completed

Started Dec 2021

Shorter than P25 for 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 13, 2022

Last Update Submit

October 17, 2022

Conditions

Periodontitis

Keywords

PeriodontitisNon-surgical treatmentAtorvastatinPhase 1 therapy

Outcome Measures

Primary Outcomes (3)

  • Probing depth

    6 weeks

  • Bleeding index

    6 weeks

  • Plaque index

    6 weeks

Secondary Outcomes (1)

  • Assessment of transforming growth factor in gingival crevicular fluid

    6 weeks

Study Arms (3)

Phase 1 therapy

OTHER
Other: Scaling and debridement only

Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel

ACTIVE COMPARATOR
Drug: Atorvastatin Calcium

Phase 1 therapy with atorvastatin loaded into in-situ gel

ACTIVE COMPARATOR
Drug: Atorvastatin Calcium

Interventions

Atorvastatin CalciumDRUG

Atorvastatin loaded into nano particles in-situ gel adjunctive to scaling and debridement

Phase 1 therapy with atorvastatin loaded into cubosomal in-situ gel
Scaling and debridement onlyOTHER

Scaling and debridement only

Phase 1 therapy

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy patients
  • Patients with moderate periodontitis

You may not qualify if:

  • Pregnant women
  • Lactating women
  • Patients with chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science and Technology (MUST)

Giza, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

AtorvastatinTooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant - Pharmaceutics Department - Faculty of Pharmacy

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 18, 2022

Study Start

December 7, 2021

Primary Completion

April 15, 2022

Study Completion

June 30, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)