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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Apical Periodontitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

Visual Analogue Scale (VAS)

Time frame: up to 72 hours

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.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Evaluation of Post-Operative Pain Following the Use of Nano-Calcium Hydroxide as an Intracanal Medicament: A Randomized Controlled Trial

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jul 9, 2025
Registry last updated: Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed