Antimicrobial Efficacy of Four Different Irrigation Protocols

NCT03668899 | Completed Results

• 1 other identifier: A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

proper disinfection of root canal system before obturation is a must for long term success of endodontic treatment, therefore a proper irrigant is mandatory, therefore investigators are studying the antibacterial effects of 4 different irrgating solutions in root canal treatment of patients diagnosed with necrotic pulps in their mandibular posterior teeth. patients will be recruited from outpatient clinic of the endodontic department in cairo university. endodontic treatment will be carried out as usual and samples from the infected root canals will be collected before and after preparation to be cultivated and analyzed at the laboratories of microbiology of faculty of medicine, cairo university

Conditions

Dental Pulp Necrosis

Outcome Measures

Primary Outcomes (1)

• Number of Colony Forming Units Per Millilitre

  activity of the irrigating solution against bacteria in the root canal system, the less the number of colony forming units the better the irrigating solution is

  1 week after culture

Secondary Outcomes (1)

• Numerical Rating Scale

  after 6 hours,12 hours, 24 hours, 48 hours, 72 hours and 7 days postoperatively

Study Arms (4)

Chitosan NPs group

EXPERIMENTAL

irrigation with Chitosan nanoparticles (final flush)

Procedure: irrigation

Chlorhexidine group

EXPERIMENTAL

irrigation with CHX (final flush)

Procedure: irrigation

Combination group

EXPERIMENTAL

irrigation with CHX/ nano Chitosan combination (final flush)

Procedure: irrigation

Hypochlorite group

ACTIVE COMPARATOR

irrigation with NaOCL (final flush)

Procedure: irrigation

Interventions

irrigation PROCEDURE

irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection

Chitosan NPs group; Chlorhexidine group; Combination group; Hypochlorite group

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient's age between 22-45 years.
• Both male and female.
• Patient who are medically free and with good health
• Necrotic Mandibular posterior teeth

You may not qualify if:

• Pregnant females.
• Teeth with vital inflamed pulps, symptomatic periapical abscess and facial cellulitis, periodontally diseased and hopeless teeth.
• Teeth with previous fillings and/ or previous endodontic treatment

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Amira Farouk
• Organization: CairoU

Amirafarouk77@gmail.com

01007192834

Study Officials

• Maha Nasr, Masters

  studying for PhD in Cairo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of Endodontics

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: January 25, 2020
• Primary Completion: April 30, 2020
• Study Completion: August 15, 2020
• Last Updated: June 29, 2025
• Results First Posted: June 29, 2025

Record last verified: 2025-06

Locations

EG (1)