The Effect of Different Intracanal Medicaments on Periapical Lesion Healing

NCT07237620 | Recruiting

• 1 other identifier: 1109202503
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is planned to evaluate the effects of two different intracanal medicaments-calcium hydroxide and diclofenac sodium-on periapical healing following endodontic retreatment. Fifty-four patients will be included and randomly assigned into two groups according to the type of medicament used. All procedures will be performed by a single experienced endodontist under standardized clinical conditions. Periapical lesion healing will be assessed radiographically at baseline and after 12 months using fractal analysis to quantitatively evaluate bone regeneration. The primary outcome will be the change in the fractal dimension values between the initial and follow-up radiographs.

Conditions

Periapical Lesion Healing; Apical Periodontitis

Keywords

Apical Periodontitis; intracanal medicaments; Diclofenac sodium; Calcium hydroxide; Fractal analysis; Endodontic retreatment

Outcome Measures

Primary Outcomes (1)

• Periapical Lesion Healing

  The primary outcome is to be the reduction in periapical lesion volume, which will be assessed by fractal analysis of periapical radiographs obtained before treatment and at the 12-month follow-up.

  1 year

Study Arms (2)

Diclofenac sodium

EXPERIMENTAL

1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water. After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point.

Procedure: Diclofenac sodium

Calcium hydroxide

ACTIVE COMPARATOR

1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water.After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length. The medicament is to be condensed to the canal orifice with a sterile paper point.

Procedure: Diclofenac sodium

Interventions

Diclofenac sodium PROCEDURE

Group 1: 1 g of CH (Kalsin, Konya, Turkey) is to be mixed with 1 mL of distilled water. Group 2: 1 g of DCS (Fagron, Rotterdam, Netherlands) is to be mixed with 1 mL of distilled water. After preparation, the medicaments are to be placed into the canal using a size 25 lentulo spiral (Dentsply Sirona, Switzerland) set 2 mm short of the working length.

Also known as: Calcium hydroxide

Calcium hydroxide; Diclofenac sodium

Eligibility Criteria

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

You may qualify if:

• The study is planned to include patients aged 18-60 years who are systemically healthy (ASA I-II), present with apical periodontitis after primary root canal treatment, and have single-rooted, root-filled mandibular teeth with a periapical index (PAI) score of ≥3.
• Endodontic treatment failure is to be evaluated based on clinical and radiographic examinations. The duration of the initial endodontic treatment is to be at least four years or longer and/or the teeth are to exhibit clinical symptoms and signs. Previous root canal fillings are to be assessed for obturation quality and classified as satisfactory if they meet the following criteria: no visible voids, good condensation, and termination within 1-2 mm of the radiographic apex. If one or more of these criteria are not fulfilled, the obturation is to be classified as poor quality.
• The presence of post-treatment apical periodontitis, poor obturation quality, and/or persistent or newly developed symptoms (such as spontaneous pain, tenderness to palpation or percussion) and/or sinus tract formation are to be considered as indications for retreatment.

You may not qualify if:

• Patients with a history of psychiatric disorders, allergic reactions, or pregnancy, and those who have taken analgesics within seven days prior to treatment or antibiotics within the previous three months, are to be excluded from the study.
• Teeth presenting with a periodontal pocket depth greater than 4 mm, severe coronal destruction preventing rubber dam placement, vertical root fracture, internal or external resorption, ankylosis, overfilling, open apex, or that have undergone surgical or nonsurgical retreatment after primary therapy are to be excluded. Teeth with perforation or fractured instruments are also to be excluded.

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Merve Sarı

Hatay, Antakya, 31060, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• Negm MM. Effect of intracanal use of nonsteroidal anti-inflammatory agents on posttreatment endodontic pain. Oral Surg Oral Med Oral Pathol. 1994 May;77(5):507-13. doi: 10.1016/0030-4220(94)90233-x.

  PMID: 8028874 BACKGROUND

• Zhang S, Qu X, Tang H, Wang Y, Yang H, Yuan W, Yue B. Diclofenac Resensitizes Methicillin-Resistant Staphylococcus aureus to beta-Lactams and Prevents Implant Infections. Adv Sci (Weinh). 2021 May 3;8(13):2100681. doi: 10.1002/advs.202100681. eCollection 2021 Jul.

  PMID: 34258168 BACKGROUND

• de Freitas RP, Greatti VR, Alcalde MP, Cavenago BC, Vivan RR, Duarte MA, Weckwerth AC, Weckwerth PH. Effect of the Association of Nonsteroidal Anti-inflammatory and Antibiotic Drugs on Antibiofilm Activity and pH of Calcium Hydroxide Pastes. J Endod. 2017 Jan;43(1):131-134. doi: 10.1016/j.joen.2016.09.014. Epub 2016 Dec 6.

  PMID: 27939738 BACKGROUND

• Adl A, Motamedifar M, Malekzadeh P, Sedigh-Shams M. Disinfection of dentinal tubules with diclofenac sodium and N-Acetylcysteine compared with calcium hydroxide as intracanal medicaments against Enterococcus faecalis. Aust Endod J. 2022 Dec;48(3):386-391. doi: 10.1111/aej.12575. Epub 2021 Oct 7.

  PMID: 34617640 BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Diclofenac; Calcium Hydroxide

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Merve Sarı, DDS,MSc

  Mustafa Kemal University Hatay, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Sarı, DDS,MSc

CONTACT

+905546430401; sarimerve94@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients are to be randomly assigned into two groups (Ca(OH)₂ and DCS) using a four-block randomization technique (allocation ratio 1:1) via www.randomizer.org. The intracanal medicaments are to be prepared by an independent clinician not involved in the study. Both the operator and the patient are to be blinded to the type of medicament used. The medicaments will have similar appearance, color, and consistency to maintain blinding.
• 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: November 16, 2025
• First Posted: November 20, 2025
• Study Start: September 15, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)