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

NCT ID: NCT05860712

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-20
• Study Completion Date: 2024-11-22

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 .

Conditions

Irreversible Pulpitis; Caries,Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sodium hypochlorite Irrigation

standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, and a sharp spoon excavator will remove pulpal tissues to the orifice level , the working lengths of root canals were estimated by apex locator and Cleaning and shaping of the root canals was done by rotary files .The pre - irrigation sample were collected after debridement of the radicular pulp tissues by a sterile paper point ,then Second microbial sample : The canals were irrigated with Sodium hypochlorite Irrigation (group A) .All the microbiological culturing procedures were carried out in the Microbiology and Immunology Department , the plates were examined and the colonies were directly counted using colony forming unit .

Group Type: ACTIVE_COMPARATOR

Irrigation

Intervention Type: 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.

Cinnamon extract Irrigation

standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed handpiece with copious irrigation, and a sharp spoon excavator will remove pulpal tissues to the orifice level , the working lengths of root canals were estimated by apex locator and Cleaning and shaping of the root canals was done by rotary files .The pre - irrigation sample were collected after debridement of the radicular pulp tissues by a sterile paper point ,then Second microbial sample : The canals were irrigated with cinnamon Irrigation (group B) . All the microbiological culturing procedures were carried out in the Microbiology and Immunology Department , the plates were examined and the colonies were directly counted using colony forming unit .

Group Type: SHAM_COMPARATOR

Irrigation

Intervention Type: 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.

Interventions

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 extract.These extracts were stored in dark coloured bottles at 4 degree Celsius until use.

Intervention Type: OTHER

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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• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amany Hossam

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Amany H Hossam eldeen, M.sc

Role: primary

amany-ibrahim@dentistry.cu.edu.eg

01143416770

Yossra M Mohamed, Phd

Role: backup

yousra.mohamed@dentistry.cu.edu.eg

01273335144

Other Identifiers

17279

Identifier Type: -

Identifier Source: org_study_id