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

NCT05860712 | Recruiting

• 1 other identifier: 17279
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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 .

Conditions

Irreversible Pulpitis; Caries,Dental

Keywords

antimicrobial and post operative pain evaluation

Outcome Measures

Primary Outcomes (1)

• Change in bacterial count.

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

  Day 1

Secondary Outcomes (1)

• post operative pain evaluation

  6,12,24,48,72 hour

Study Arms (2)

Sodium hypochlorite Irrigation

ACTIVE COMPARATOR

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 .

Other: Irrigation

Cinnamon extract Irrigation

SHAM COMPARATOR

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 .

Other: Irrigation

Interventions

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.

Cinnamon extract Irrigation; Sodium hypochlorite Irrigation

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: January 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: November 22, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

EG (1)