Clinical trial NCT06597825: Antibacterial Effect of NaOCl With Etidronic Acid in Apical Periodontitis Treatment
Official title: Antibacterial Effect of Sodium Hypochlorite Combined With Etidronic Acid in Apical Periodontitis Treatment: A Prospective, Single Blinded, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Bacterial reduction
etidronic acid
root canal irrigation
sodium hypochlorite
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total bacterial load (CFU/ml) in root canal samples of teeth
timeFrame: From enrollment to the end of treatment at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antakya
country: Turkey
facility: Hatay Mustafa Kemal University Dentistry Faculty Department of Endodontics
state: Hatay
Study officials:
References:
citation: 1. Siqueira JF Jr, Rôças IN. Clinical implications and microbiology of bacterial persistence after treatment procedures. J Endod 2008;34:1291-12301.e3. 2. Ricucci D, Siqueira JF Jr, Bate AL, Pitt Ford TR. Histologic investigation of root canal-treated teeth with apical periodontitis: a retrospective study from twenty-four patients. J Endod 2009;35:493-502. 3. Zandi H, Petronijevic N, Mdala I, et al. Outcome of endodontic retreatment using 2 root canal irrigants and influence of infection on healing as determined by a molecular method: a randomized clinical trial. J Endod 2019;45:1089-10898.e5. 4. Rodrigues RCV, Zandi H, Kristoffersen AK, Enersen M, Mdala I, Ørstavik D, Rôças IN, Siqueira JF Jr. Influence of the Apical Preparation Size and the Irrigant Type on Bacterial Reduction in Root Canal-treated Teeth with Apical Periodontitis. J Endod. 2017 Jul;43(7):1058-1063. 5. Rôças IN, Provenzano JC, Neves MA, Siqueira JF Jr. Disinfecting Effects of Rotary Instrumentation with Either 2.5% Sodium Hypochlorite or 2% Chlorhexidine as the Main Irrigant: A Randomized Clinical Study. J Endod. 2016 Jun;42(6):943-7. 6. Paiva SS, Siqueira JF Jr, Rôças IN, Carmo FL, Ferreira DC, Curvelo JA, Soares RM, Rosado AS. Supplementing the antimicrobial effects of chemomechanical debridement with either passive ultrasonic irrigation or a final rinse with chlorhexidine: a clinical study. J Endod. 2012 Sep;38(9):1202-6. 7. Siqueira JF Jr, Rôças IN. Optimizing single-visit disinfection with supplementary approaches: a quest for predictability. Aust Endod J 2011;37:92-8.