Antibacterial Effect of NaOCl With Etidronic Acid in Apical Periodontitis Treatment

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)

• Registration Number: NCT06597825
• Lead Sponsor: Mustafa Kemal University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-17
• Primary Completion: 2020-12-23
• Study Completion: 2021-01-10
• Status Verified: 2024-09
• Study First Submitted: 2024-09-01
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
İrrigation protocols (Group I)	root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)	Group I: the root canal was irrigated with 1 ml of 17% EDTA (Microvem, Istanbul, Turkey), and the solution was kept in the canal for 1 minute. The canal was subsequently irrigated with 2 ml of distilled water and 3 ml of 2.5% NaOCl for 1 minute.
İrrigation protocols (Group II)	root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)	Group II: HEDP (DualRinse HEDP, Medcem, Vienna, Austria), containing 0.9 mg of etidronic acid per capsule, was added to 10 ml of 2.5% NaOCl in a sterile container according to the manufacturer's instructions. The solution, which was prepared just before use in the canal, was mixed for 1 min to ensure that the powder was fully dissolved. The canal was then irrigated with 4 ml of the 2.5% NaOCl - 9% HEDP combined solution for 2 minutes.
İrrigation protocols (Group III)	root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)	Group III: A similar irrigation protocol to that of Group I was followed, with an additional 1-minute sonic activation using the EA device on 3 ml of 2.5% NaOCl. The tip of the EA was placed 2 mm away from the WL and the irrigant was activated with 10,000 cycles per minute with a tip size 0.04/35.
İrrigation protocols (Group IV)	root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)	Group IV: Similar to Group II, the canal was filled with 4 ml of the 2.5% NaOCl - 9% HEDP combined solution for 1 minute. The tip of the EA was placed 2 mm away from the WL, followed by 1 minute of sonic activation with the EA device (10,000 cycles per minute with a tip size 0.04/35).

Primary Outcome Measures

Name	Time	Method
Total bacterial load (CFU/ml) in root canal samples of teeth	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.

Trial Locations

Locations (1)

Hatay Mustafa Kemal University Dentistry Faculty Department of Endodontics; 🇹🇷 Antakya, Hatay, Turkey