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Other

FS with ZOE Materials for Toothache

Phase < 1
Recruiting
Led By Jayakumar Jayaraman, BDS MDS PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial compares the effectiveness of two base materials (containing eugenol & without eugenol) used in primary molar pulpotomies to determine which one is more successful.

Who is the study for?
This trial is for children aged 3 to 7 with toothache due to reversible pulpitis in primary molars, which are not overly resorbed and can be restored with a crown. Kids mustn't have spontaneous pain, signs of advanced pulp issues, excessive bleeding, swelling or fistulae, nor any root resorption seen on x-rays.Check my eligibility
What is being tested?
The study compares two base materials used in pulpotomies: one eugenol based (traditional ZOE) and one non-eugenol based (Cavit), both combined with Ferric Sulfate. It's designed to see if the non-eugenol option reduces failures like internal resorption.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of treatment, allergic reactions to materials used, or failure of the pulpotomy leading to further dental problems such as infection or tooth loss.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical success rate
Radiographic success rate

Trial Design

2Treatment groups
Experimental Treatment
Group I: non-eugenol based ZOE and Ferric SulfateExperimental Treatment1 Intervention
non-eugenol based ZOE and Ferric Sulfate in primary molar pulpotomy procedures.
Group II: eugenol based zinc oxide and Ferric SulfateExperimental Treatment1 Intervention
eugenol based zinc oxide and Ferric Sulfate in primary molars pulpotomies procedures.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
699 Previous Clinical Trials
22,884,895 Total Patients Enrolled
Jayakumar Jayaraman, BDS MDS PhDPrincipal InvestigatorVirginia Commonwealth University

Media Library

FS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05557812 — Phase < 1
Toothache Research Study Groups: non-eugenol based ZOE and Ferric Sulfate, eugenol based zinc oxide and Ferric Sulfate
Toothache Clinical Trial 2023: FS Highlights & Side Effects. Trial Name: NCT05557812 — Phase < 1
FS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557812 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total participant count for this research endeavor?

"Indeed, according to clinicaltrials.gov, this research endeavour remains recruiting participants since it was first advertised on February 2nd 2023 and last modified on June 6th of the same year. 150 patients are necessary from a single location for successful completion of the investigation."

Answered by AI

Does the research encompass individuals aged 60 or older?

"Eligibility for this trial is limited to children between the ages of 3 and 7. Additionally, there are 11 studies available for those younger than 18 years old, as well as 8 trials designed specifically for elderly participants over 65."

Answered by AI

Are new participants still welcomed to join this experiment?

"Clinicaltrials.gov confirms that this trial is open for enrolment, having been initially posted on February 2nd 2023 and last amended on the 6th of the same month."

Answered by AI

What criteria must I satisfy to partake in this clinical investigation?

"This medical trial seeks 150 participants aged 3-7 years old who are suffering from a toothache. Those selected must have carious teeth with reversible pulpitis and no more than one third of the roots undergoing physiological resorption, as well as being restorable by stainless steel crowns."

Answered by AI
~0 spots leftby May 2024