Actively Recruiting

Phase Not Applicable
Age: 4Years - 8Years
All Genders
Healthy Volunteers
ID05860712

Evaluation of Antimicrobial Potency of Cinnamon Extract Versus Sodium Hypochlorite Irrigant Following Pulpectomy of Primary Teeth (Randomized Clinical Trial)

Led by Cairo University · Updated on 2024-08-22

26

Participants Needed

1

Research Sites

9 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effectiveness of cinnamon extract versus sodium hypochlorite as root canal irrigants during pulpectomy procedures in primary teeth with irreversible pulpitis. The study focuses on reducing bacterial count since primary teeth with non-vital pulp often contain multiple types of bacteria, including anaerobes, making treatment challenging. Researchers are exploring natural alternatives like cinnamon due to concerns about side effects and safety of synthetic irrigants. Participants will undergo a standardized pulpectomy where infected pulp tissue is removed mechanically using rotary files after estimating root canal length with an apex locator. Two groups will be compared: one receiving sodium hypochlorite irrigation and the other receiving cinnamon extract irrigation prepared from cinnamon bark. Microbial samples are collected before and after irrigation to assess bacterial reduction. Children aged 4 to 8 years with carious primary molars requiring pulpectomy will be involved. The study includes collection of microbial samples, assessment of bacterial colonies, and evaluation of post-operative pain at multiple time points up to 72 hours. All microbiological analysis is conducted in a specialized department. Participants will be monitored for changes in bacterial count on day 1 and pain levels over 3 days following treatment.

CONDITIONS

Brief Title

Evaluation of Antimicrobial, Post Operative Pain of Cinnamon Extract Versus Sodium Hypochlorite Irrigant Following Pulpectomy of Primary Teeth

Who Can Participate

Age: 4Years - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 4 to 8 years, in good general health and medically free
  • Cooperative patients able to comply with dental treatment
  • Parents have provided written informed consent
  • No antibiotics taken within the last 2 weeks
  • Carious primary molars with irreversible pulpitis
  • Teeth showing localized swelling, sinus, or pain on percussion indicating non-vital pulp
  • Presence of periapical and furcation radiolucency
  • Teeth with no more than one-third root resorption on radiograph
Not Eligible

You will not qualify if you...

  • Children with medical, physical, or mental conditions
  • Severely uncooperative children
  • Primary molars with congenital anomalies
  • Teeth with un-restorable crowns
  • Root resorption greater than half of the root

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants undergo a pulpectomy procedure where the root canals are cleaned and shaped, followed by irrigation with either cinnamon extract or sodium hypochlorite solution.

1 treatment visit (in-person)

Follow-up

Duration - 72 hours

Participants are monitored for post-operative pain at multiple timepoints after the treatment.

Visits at 6, 12, 24, 48, and 72 hours post-treatment

Trial Site Locations

Total: 1 location

1

Cairo university

Cairo, Egypt

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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