Antibacterial Effect of NaOCl With Etidronic Acid in Apical Periodontitis Treatment

Mustafa Kemal University

Status: Completed

Conditions: Healthy

Treatments: Drug: root canal irrigation solutions (NaOCl+EDTA, NaOCl+HEDP)

Study type: Interventional

Funder types: Other

Identifiers

NCT06597825

Clinical Research-2019/37

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 4 patient groups

İrrigation protocols (Group I)

Experimental group

Description:

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.

Treatment:

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

İrrigation protocols (Group II)

Experimental group

Description:

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.

Treatment:

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

İrrigation protocols (Group III)

Experimental group

Description:

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.

Treatment:

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

İrrigation protocols (Group IV)

Experimental group

Description:

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).

Treatment:

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