Effect of Different Chelation Protocols on the Healing of Periapical Lesions in Teeth With Chronic Apical Periodontitis

NCT07353008 | Active Not Recruiting

• 1 other identifier: 2801
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effects of different irrigation protocols using ethylenediaminetetraacetic acid (EDTA) and etidronic acid (HEBP) on periapical lesion healing and postoperative pain in single-rooted, single-canal mandibular anterior and premolar teeth diagnosed with chronic apical periodontitis.

Conditions

Chronic Apical Periodontitis

Keywords

Etidronic acid (HEBP); Ethylenediaminetetraacetic acid (EDTA); Sequential chelation; Consecutive chelation

Outcome Measures

Primary Outcomes (1)

• Periapical Lesion Healing

  Radiographic periapical status assessed using the Periapical Index (PAI) according to Ørstavik et al., with scores ranging from 1 (normal periapical structures) to 5 (severe apical periodontitis), based on the degree of periapical radiolucency. The primary outcome will be periapical lesion healing, evaluated by changes in periapical index (PAI) scores on periapical radiographs taken before treatment and at the 12-month follow-up.

  1 year

Study Arms (3)

Group I: Final irrigation with 2.5% NaOCl and 17% EDTA

ACTIVE COMPARATOR

After preparation of the access cavity the working length (WL) will be determined using an electronic apex locator (Root ZX \[Morita, Tokyo, Japan\]) and confirmed radiographically. Following glide path preparation, the root canals will be shaped to the working length using a Resiproc files (VDW, Munich, Germany) in accordance with the manufacturer's instructions, employing the crown-down preparation technique. During canal preparation, irrigation will be performed with a total of 20 mL of 2.5% NaOCl. After completion of preparation, irrigation will be carried out with 10 mL of distilled water, followed by sequential irrigation with 3 mL of 17% EDTA, 10 mL of distilled water, and 2 mL of 2.5% NaOCl.

Procedure: Final irrigation with 2.5% NaOCl and 17% EDTA

Group II: Final irrigation with 2.5% NaOCl and 9% HEBP

EXPERIMENTAL

After preparation of the access cavity, the working length (WL) will be determined using an electronic apex locator (Root ZX \[Morita, Tokyo, Japan\]) and confirmed radiographically. Following glide path preparation, the root canals will be shaped to the working length using a Resiproc files (VDW, Munich, Germany) in accordance with the manufacturer's instructions, employing the crown-down preparation technique. During canal preparation, irrigation will be performed with a total of 20 mL of 2.5% NaOCl. After completion of preparation, irrigation will be carried out with 10 mL of distilled water, followed by final irrigation with 5 mL of 2.5% NaOCl-9% HEBP.

Procedure: Final irrigation with 2.5% NaOCl and 9% HEBP

Group III: Irrigation with 2.5% NaOCl-9% HEBP during both preparation and final irrigation

EXPERIMENTAL

After preparation of the access cavity, the working length (WL) will be determined using an electronic apex locator (Root ZX \[Morita, Tokyo, Japan\]) and confirmed radiographically. Following glide path preparation, the root canals will be shaped to the working length using a Resiproc files (VDW, Munich, Germany) in accordance with the manufacturer's instructions, employing the crown-down preparation technique. During both canal preparation and final irrigation, a total of 25 mL of 2.5% NaOCl-9% HEBP will be used for irrigation.

Procedure: Irrigation with 2.5% NaOCl-9% HEBP during both preparation and final irrigation

Interventions

Final irrigation with 2.5% NaOCl and 17% EDTA PROCEDURE

During canal preparation, irrigation will be performed with a total of 20 mL of 2.5% NaOCl. After completion of preparation, irrigation will be carried out with 10 mL of distilled water, followed by sequential irrigation with 3 mL of 17% EDTA, 10 mL of distilled water, and 2 mL of 2.5% NaOCl.

Group I: Final irrigation with 2.5% NaOCl and 17% EDTA

Final irrigation with 2.5% NaOCl and 9% HEBP PROCEDURE

During canal preparation, irrigation will be performed with a total of 20 mL of 2.5% NaOCl. After completion of preparation, irrigation will be carried out with 10 mL of distilled water, followed by final irrigation with 5 mL of 2.5% NaOCl-9% HEBP.

Group II: Final irrigation with 2.5% NaOCl and 9% HEBP

Irrigation with 2.5% NaOCl-9% HEBP during both preparation and final irrigation PROCEDURE

During both canal preparation and final irrigation, a total of 25 mL of 2.5% NaOCl-9% HEBP will be used for irrigation.

Group III: Irrigation with 2.5% NaOCl-9% HEBP during both preparation and final irrigation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Eligible patients will present with restorable mandibular single-rooted premolar and anterior teeth, a healthy periodontal status (periodontal pocket depth ≤3 mm), and a clinical diagnosis of chronic apical periodontitis. The diagnosis of chronic apical periodontitis will be based on the absence of clinical symptoms, the presence of pulpal necrosis, negative responses to electric pulp testing and cold testing, and the detection of a radiolucent area in the periapical region on radiographic examination. In addition, included teeth must exhibit a periapical lesion with a Periapical Index (PAI) score of 2 or higher.

You may not qualify if:

• Patients with systemic diseases (such as diabetes mellitus, hypertension, chronic liver disease, or coagulation disorders), those with bone metabolism disorders and/or those using medications that affect bone metabolism (including steroids and bisphosphonates), and pregnant patients will be excluded from the study.
• In addition, teeth presenting with periodontal pocket depths greater than 3 mm, internal or external root resorption, vertical or horizontal root fractures, a history of previous root canal treatment, the presence of a sinus tract, or intraoral or extraoral abscess associated with the involved tooth, as well as teeth deemed non-restorable, will not be included in the study.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Department of Endodontics, Faculty of Dentistry, Hatay Mustafa Kemal University

Hatay, 31000, Turkey (Türkiye)

Location

Related Publications (5)

• Campello AF, Rodrigues RCV, Alves FRF, Miranda KR, Brum SC, Mdala I, Siqueira JF Jr, Rocas IN. Enhancing the Intracanal Antibacterial Effects of Sodium Hypochlorite with Etidronic Acid or Citric Acid. J Endod. 2022 Sep;48(9):1161-1168. doi: 10.1016/j.joen.2022.06.006. Epub 2022 Jun 22.

  PMID: 35750221 RESULT

• Hazar E, Hazar A. Effects of phytic acid and etidronic acid using continuous and sequential chelation on the removal of smear layer, dentin microhardness, and push-out bond strength of calcium silicate-based cement. BMC Oral Health. 2025 Apr 24;25(1):633. doi: 10.1186/s12903-025-06010-5.

  PMID: 40275217 RESULT

• Tartari T, Wilchenski BS, de Souza Lima LA, Vivan RR, Ballal V, Duarte MAH. The use of sodium hypochlorite mixed with etidronic acid during canal preparation increases debris extrusion. Aust Endod J. 2023 Dec;49(3):584-591. doi: 10.1111/aej.12788. Epub 2023 Aug 11.

  PMID: 37571801 RESULT

• Razumova S, Brago A, Kryuchkova A, Troitskiy V, Bragunova R, Barakat H. Evaluation of the efficiency of smear layer removal during endodontic treatment using scanning electron microscopy: an in vitro study. BMC Oral Health. 2025 Jan 28;25(1):151. doi: 10.1186/s12903-025-05510-8.

  PMID: 39875846 RESULT

• Pandya DS, Kritika S, Sanjeev K, Mahalaxmi S, Neelakantan P. Endotoxin Levels after Calcium Hydroxide Placement in Root Canals Irrigated with Continuous or Sequential Chelation in Previously Treated Teeth with Symptomatic Apical Periodontitis: A Randomized Controlled Clinical Trial. J Endod. 2025 Nov;51(11):1519-1525. doi: 10.1016/j.joen.2025.08.004. Epub 2025 Aug 18.

  PMID: 40835176 RESULT

MeSH Terms

Interventions

Edetic Acid; Therapeutic Irrigation

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study is designed as a prospective, parallel-group, double-blind, randomized controlled clinical trial.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)