Clinical & Radiographic Evaluation of LSTR in Non-vital Primary Molars Using Two Different Vehicles

NCT05079802 | Unknown Phase 3

• 1 other identifier: PED21-7D
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

LSTR will be done for primary teeth with significant root resorption needing non-vital pulp therapy to save such teeth for up to 12 months. The first part will be in vitro study to compare the antimicrobial effect of double antibiotic paste mixed with chitosan nanoparticle vs double antibiotic paste mixed with propylene glycol. The second part will be randomized clinical trial comparing the clinical and radiographic success of LSTR in study group where double antibiotic mix is mixed with chitosan nanoparticles and control group where double antibiotic paste is mixed with propylene glycol .

Conditions

Resorption of Tooth or Root

Outcome Measures

Primary Outcomes (2)

• Clinical outcomes through clinical examination

  No pain. No abnormal mobility. No swelling

  Follow up will be for one year with recall visits at 1, 3, 6 and 12 months

• Radiographic outcomes by comparing pre and post treatment radiographic pathologic radiolucent area/s size/s

  Decrease in size / absence of interradicular radiolucency. Decrease in size /absence of internal resorption.

  Follow up will be for one year with recall visits at 1, 3, 6 and 12 months

Study Arms (2)

Group 1

EXPERIMENTAL

study group

Drug: Double antibiotic paste mixed with chitosan nanoparticles

Group 2

OTHER

control group

Drug: Double antibiotic paste mixed with propylene glycol

Interventions

Double antibiotic paste mixed with chitosan nanoparticles DRUG

Lesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with chitosan nanoparticles gel

Also known as: DAP mixed with CHNPs

Group 1

Double antibiotic paste mixed with propylene glycol DRUG

Lesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with propylene glycol

Also known as: DAP mixed with PG

Group 2

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Non-vital primary molars
• With root resorption more than 1 mm that needs to be retained a tooth for up to 12 months that otherwise would be extracted
• Without mobility up to grade I mobility.

You may not qualify if:

• Non-vital primary molars
• With perforation into the bifurcation.
• Badly broken down.
• With no root resorption.
• With excessive bone loss in furcation area involving underlying tooth germ.
• Nearing exfoliation.
• Participants that
• Have previous history of allergy to the antibiotics used in the study.
• Their caregivers do not oblige to signing the informed consent.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Propylene Glycol

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Olaa Abdel Geleel, PhD

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Dina AH Ghaneya, MS

CONTACT

01006263615; dina.abdelhaleem88@gmail.com

Radwa AE El Shakhs, MS

CONTACT

01223183320; drradwaelshakhs@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisting teacher

Study Record Dates

• First Submitted: October 3, 2021
• First Posted: October 15, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share