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

Not Applicable

Completed

• Conditions: Chronic Apical Periodontitis
• Interventions: Drug: Conventional Calcium Hydroxide (CH); Drug: Nanocalcium Hydroxide (NCH)

• Registration Number: NCT07057336
• Lead Sponsor: Cukurova University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-14
• Primary Completion: 2025-01-15
• Study Completion: 2025-02-20
• Status Verified: 2025-06
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Calcium Hydroxide (CH)	Conventional Calcium Hydroxide (CH)	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.
Nanocalcium Hydroxide (NCH)	Nanocalcium Hydroxide (NCH)	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	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.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Sarıçam, Turkey