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NCT Number: NCT05860712

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

The aim of the study is to evaluate effectiveness of cinnamon extract versus sodium hypochlorite as root canal irrigant for in pulpectomy of primary teeth in reduction of bacterial count .

Recruiting

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Preservation of primary teeth with non-vital pulp is a major problem in pediatric dentistry, as it is a poly-microbial and dominated by obligatory anaerobic bacteria. Regarding these case preferable treatment modality is pulpectomy . The objective of pulpectomy is complete removal of necrotic and irreversibly infected pulp of an affected tooth but due to limited ability of mechanical preparation to eliminate entrapped micro-organisms in the canal space owing to the tortuous and complex nature of the root canal system .Thus, the use of antimicrobial agents has been recommended as an adjunct to mechanical instrumentation in deciduous teeth . Due to potential side effects, safety concerns of synthetic drugs and cytotoxic reactions of commercial intra canal irrigants and their limited ability to eliminate bacteria from dentinal tubules . Finding the best irrigating solution for endodontic therapy in primary and permanent teeth is still a working progress .There is a growing interest in using sustainable products of natural origin as an alternative to commercially available industrial ones .Cinnamon , which has gained popularity in recent time due its antibacterial , antifungal , anti-inflammatory & antiseptic activity . It has shown effectiveness against S. mutans and E. fecalis organisms . It is also known to show a wide spectrum of action on gram positive and gram negative bacteria .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children:
  • Aged 4 to 8, in good general health, and medically free.
  • Cooperative patients who will comply to dental treatment .
  • Parents provided with written informed consent.
  • No previous history of antibiotics administration or last dose was taken from at least 2 weeks.
  • Teeth:
  • Carious primary molars with irreversible pulpitis.
  • Presence of localized swelling ,sinus and pain on percussion which indicate non vital pulp .
  • Presence of periapical and furcation radiolucency .
  • In periapical radiograph teeth have no more than 1/3 of root resorption.

Exclusion criteria

  • Children:
  • Children with medical, physical, or mental conditions.
  • Severly Uncooperative children .
  • Teeth:
  • Primary molars with any congenital anomalies.
  • Teeth with un-restorable crowns .
  • Root resorbtion more than half of the root.

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Treatment and study plan

Irrigation

Other

Cinnamon to be prepared were mixed with 50% ethanol and this suspension was placed on the magnetic stirrer for 4 hours.Whitman's filter paper was used to obtain the filtrate which was then dried to obtain the extract. The extract was dried to evaporate the solvent to prevent the influence of extracting agent (ethanol) on the final extract. Cinnamon extract was obtained using cinnamon bark which was pulverized into medium coarse granules. The extracting agent and the procedure to obtain the final extract.These extracts were stored in dark coloured bottles at 4 degree Celsius until use.

Primary outcomes

  1. Change in bacterial count.

    Time frame: Day 1

    Quantitative.(Colony Forming Unit ) take sample by paper point before and after irrigation by control of interventional

Secondary outcomes

  1. post operative pain evaluation

    Time frame: 6,12,24,48,72 hour

    four point facial pain intensity scoring system

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation Of Antimicrobial Potency Of A Novel Cinnamon Extract Irrigant Versus Sodium Hypochlorite Irrigant Following Pulpectomy Of Primary Teeth . (A Randomized Clinical Trial)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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