Modified Surface of PLGA Nanoparticles in Smart Hydrogel

NCT05442736 | Completed Early Phase 1 DMC

• 1 other identifier: PI (1643)
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat recurrent endodontic infections

Conditions

Antibiotic Resistant Infection

Keywords

nanoparticles; endodontics infection

Outcome Measures

Primary Outcomes (1)

• controlled release of the drug with associated with infection inhibition

  drug entrapped in nanoparticles incorporated in in situ gel inhibited the biofilm formation and bacterial recurrent infection

  two weeks

Study Arms (2)

Free drug

ACTIVE COMPARATOR

Free drug incorporated in in situ gels

Drug: Ciprofloxacin

drug entrapped in nanoparticles

ACTIVE COMPARATOR

drug entrapped in nanoparticles then incorporated in in situ gels

Drug: Ciprofloxacin

Interventions

Ciprofloxacin DRUG

studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel

Also known as: device

Free drug; drug entrapped in nanoparticles

Eligibility Criteria

• Age: 40 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Root canal filled single rooted teeth with post treatment disease manifested by one or more of the following signs and symptoms:
• History of recurrent acute and/or chronic periapical abscess
• Pain on palpation and/or percussion at least after one month of previous procedure
• Radiographic evidence of bone loss either as a new developing lesion or an increase in the size of a pre-existing one.

You may not qualify if:

• Teeth that were badly broken down indicated for extraction or with difficult isolation
• Immuno-compromised patients.
• Patients with history of taking antibiotics orally.
• Periodontally affected teeth.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

Mona Arafa

Cairo, 11841, Egypt

Location

Related Publications (1)

• Fereig SA, El-Zaafarany GM, Arafa MG, Abdel-Mottaleb MMA. Tackling the various classes of nano-therapeutics employed in topical therapy of psoriasis. Drug Deliv. 2020 Dec;27(1):662-680. doi: 10.1080/10717544.2020.1754527.

  PMID: 32393082 RESULT

MeSH Terms

Interventions

Ciprofloxacin; Equipment and Supplies

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mona Arafa

  The British University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Fifty-five patients having single rooted teeth with signs and/or symptoms of post treatment disease that were indicated for non-surgical root canal retreatment were participated in this study

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 5, 2022
• Study Start: April 2, 2022
• Primary Completion: April 16, 2022
• Study Completion: April 16, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)