Clinical trial NCT05860712: Evaluation of Antimicrobial, Post Operative Pain of Cinnamon Extract Versus Sodium Hypochlorite Irrigant Following Pulpectomy of Primary Teeth
Official title: Evaluation Of Antimicrobial Potency Of A Novel Cinnamon Extract Irrigant Versus Sodium Hypochlorite Irrigant Following Pulpectomy Of Primary Teeth . (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreversible Pulpitis
Caries,Dental
Keywords: antimicrobial and post operative pain evaluation
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 26
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 .

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

* Children:

  1. Aged 4 to 8, in good general health, and medically free.
  2. Cooperative patients who will comply to dental treatment .
  3. Parents provided with written informed consent.
  4. No previous history of antibiotics administration or last dose was taken from at least 2 weeks.
* Teeth:

  1. Carious primary molars with irreversible pulpitis.
  2. Presence of localized swelling ,sinus and pain on percussion which indicate non vital pulp .
  3. Presence of periapical and furcation radiolucency .
  4. In periapical radiograph teeth have no more than 1/3 of root resorption.

Exclusion Criteria:

* Children:

  1. Children with medical, physical, or mental conditions.
  2. Severly Uncooperative children .
* Teeth:

  1. Primary molars with any congenital anomalies.
  2. Teeth with un-restorable crowns .
  3. Root resorbtion more than half of the root.

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Primary outcomes:
measure: Change in bacterial count.
timeFrame: Day 1
Secondary outcomes:
measure: post operative pain evaluation
timeFrame: 6,12,24,48,72 hour
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References: