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)

Overview

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 .

Interventions

• Other Irrigation
  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

Primary outcome measures

• Change in bacterial count. [Time frame: Day 1]

Secondary outcome measures (1)

• post operative pain evaluation [Time frame: 6,12,24,48,72 hour]

Eligibility criteria

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.

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Cairo university — Cairo

Identifiers

NCT: NCT05860712 · 17279

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗