Evaluation of Post-Operative Pain Following the Use of Nano-Calcium Hydroxide

NCT07057336 | Completed DMC

• 1 other identifier: 05.04.2024/143
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effect of different intracanal medicaments-conventional calcium hydroxide (CH) and nano-sized calcium hydroxide (NCH)-on the intensity of postoperative pain following root canal treatment in asymptomatic necrotic single-rooted teeth. The primary research question of this study is as follows: Does the use of nano-sized calcium hydroxide, compared to conventional calcium hydroxide, result in significantly reduced postoperative pain after root canal treatment? In both groups, standardized instrumentation will be performed using rotary NiTi files and 2.5% sodium hypochlorite irrigation. After cleaning and shaping, canals will be medicated with either CH or NCH, followed by temporary sealing.

Conditions

Chronic Apical Periodontitis

Keywords

Calcium Hydroxide; Nanocalcium Hydroxide; Postoperative pain; Chronic apical periodontitis; Intracanal medicament

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.

  up to 72 hours

Study Arms (2)

Conventional Calcium Hydroxide (CH)

EXPERIMENTAL

Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. Canals were then dried using sterile paper points. Conventional calcium hydroxide (CH) paste was introduced into the canal using a Lentulo spiral. A sterile cotton pellet was placed in the pulp chamber, and the cavity was sealed with glass ionomer cement.

Drug: Conventional Calcium Hydroxide (CH)

Nanocalcium Hydroxide (NCH)

EXPERIMENTAL

Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. Canals were then dried using sterile paper points. Nanocalcium hydroxide (NCH) paste was placed into the canal using a Lentulo spiral to ensure uniform distribution. The access cavity was temporarily restored with a sterile cotton pellet and glass ionomer cement.

Drug: Nanocalcium Hydroxide (NCH)

Interventions

Conventional Calcium Hydroxide (CH) DRUG

Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. The cavity was sealed temporarily with a sterile cotton pellet and glass ionomer cement. Conventional calcium hydroxide was retained for 7 days before final obturation.

Conventional Calcium Hydroxide (CH)

Nanocalcium Hydroxide (NCH) DRUG

Following completion of canal shaping with rotary instrumentation and irrigation using 5 mL of 2.5% sodium hypochlorite (NaOCl), canals were flushed sequentially with 5 mL distilled water, 5 mL of 17% ethylenediaminetetraacetic acid (EDTA), another 5 mL of distilled water, 5 mL of 2.5% NaOCl, and finally 5 mL of distilled water. The cavity was sealed temporarily with a sterile cotton pellet and glass ionomer cement. Nanocalcium hydroxide was retained for 7 days before final obturation.

Nanocalcium Hydroxide (NCH)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years
• Single-rooted permanent maxillary or mandibular teeth
• Asymptomatic teeth with necrotic pulps confirmed by negative response to cold test
• Presence of periapical radiolucency (PAI score 2-5)
• No sensitivity to percussion or palpation
• Patients who signed informed consent

You may not qualify if:

• Pregnancy or lactation
• Systemic diseases requiring antibiotic prophylaxis (e.g., infective endocarditis, immunosuppression)
• Use of antibiotics, corticosteroids, or analgesics within the past 7 days
• History of chemotherapy or radiotherapy
• Uncontrolled diabetes mellitus or hypertension
• Chronic renal failure, hematologic disorders
• Teeth with root resorption, previous endodontic treatment, or multirooted anatomy
• Teeth with periodontal pockets \>4 mm or mobility
• Inability to attend follow-up visits
• Patients with extensive coronal destruction rendering definitive restoration unfeasible

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (1)

• Amir N, Mansoor E, Eeman N, Ahmed MN, Mansoor E, Mansoor E, Hussain K, Afreixo V, Mansoor A, Brochado Martins JF, Palma PJ. Jasminum-based Nano-reinforced Calcium Hydroxide Reduces Postoperative Pain in Symptomatic Apical Periodontitis: A Randomized Controlled Trial. J Endod. 2025 Aug;51(8):996-1005. doi: 10.1016/j.joen.2025.05.016. Epub 2025 Jun 2.

  PMID: 40466913 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hamdi Oğuz Yoldaş, DDS PHD

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: May 14, 2024
• Primary Completion: January 15, 2025
• Study Completion: February 20, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)