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Completed

NCT Number: NCT06597825

Antibacterial Effect of NaOCl With Etidronic Acid in Apical Periodontitis Treatment

Sodium hypochlorite (NaOCl), the most commonly used irrigation solution during chemomechanical preparation, plays a significant role in eliminating bacteria within root canals. Additionally, after preparation with different concentrations of NaOCl, 30% to 70% resistant bacteria were observed in the root canals. For this reason, new protocols have been developed to increase the effectiveness of NaOCl in chemomechanical preparation and to support disinfection within root canals. Recently, etidronic acid (1-hydroxyethane 1,1-diphosphonic acid [HEDP]), a biocompatible chelating agent, has emerged as an alternative irrigation solution. It has been suggested to combine and use this solution with NaOCl.

This study aims to evaluate the antimicrobial effectiveness of NaOCl in the root canal, which is used in combination with HEDP or sequentially with Ethylenediaminetetraacetic acid (EDTA) in the final irrigation after retreatment. Additionally, the effect of activation with Endoactivator (EA) on microbial reduction was assessed.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatay Mustafa Kemal University Dentistry Faculty Department of Endodontics

Antakya, Hatay, 31060, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The study included teeth from patients aged 18-65 years who had no systemic disease and had not undergone antibiotic therapy in the past three months. To ensure standardization, all the treatments were performed by a single clinician.

  • A minimum of 2 years since the initial root canal treatment
  • Single rooted mandibular premolar with apical periodontitis (AP) and a canal filling within 4 mm from the apex on radiographic examination
  • The absence of pain on palpation and percussion, healthy periodontal tissues, and no mobility,
  • Presence of a coronal restoration (teeth that have not retained permanent restoration over the previous root canal treatment).

Exclusion criteria

  • Patients who have received antibiotic therapy in the last 3 months,
  • Patients with diabetes, pregnancy, immunosuppression and cardiovascular disease,
  • Absence of a coronal restoration
  • Presence of pain on palpation and percussion, mobility.

Treatment and study plan

root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)

Drug

After cavity preparation with sterile burs, rubber dam components were applied to the tooth. The root canal filling material was removed via retreatment files. After the working length was determined, in all the groups, the canals were filled with distilled water. S1were taken from the canal after retreatment. Irrigation protocols were applied for 4 groups. S2 were taken from the canal. Intracanal medicament was placed in the root canal, the cavity was securely sealed. After 14 days,the medicament was removed with 10 mL of 17% EDTA and subsequently irrigated with 5 ml of distilled water, S3 was taken by sterile paper points. The final irrigation was performed according to the group to which the tooth belonged, and S4 was collected as before. the root canals were dried with sterile paper points and filled gutta-percha master cones and sealer.

Other names: Root canal irrigation activation (Endoactivator) (Device)

Primary outcomes

  1. Total bacterial load (CFU/ml) in root canal samples of teeth

    Time frame: From enrollment to the end of treatment at 2 weeks

    In all the groups, A sterile paper point of size R50 was placed at the working length (WL) and left in the canal for 1 minute. Three paper points were then placed into an Eppendorf tube containing phosphate-buffered saline (PBS). The samples taken from the canal after retreatment were recorded as the S1. After root canal preparation and irrigation protocols, S2 sample was taken. After dried protocol, medicament was placed in the root canal.After 14 days,the intracanal medicament was removed with 17% EDTA. The root canal was irrigated with 5 ml of distilled water.S3 was taken by sterile R50 paper points. The final irrigation was performed according to the group to which the tooth belonged,the S4 was collected as before.Each sample obtained from the patient was placed into culture medium.The inoculated plates were incubated at 37°C for 48 hours. After incubation, the total bacterial counts were determined by calculating the number of colony-forming units (CFU/ml) on the plates.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study title

Antibacterial Effect of Sodium Hypochlorite Combined With Etidronic Acid in Apical Periodontitis Treatment: A Prospective, Single Blinded, Randomised Clinical Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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