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

Çukurova University

Status: Completed

Conditions: Chronic Apical Periodontitis

Treatments: Drug: Nanocalcium Hydroxide (NCH); Drug: Conventional Calcium Hydroxide (CH)

Study type: Interventional

Funder types: Other

Identifiers

NCT07057336

05.04.2024/143

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Conventional Calcium Hydroxide (CH)

Experimental group

Description:

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.

Treatment:

Drug: Conventional Calcium Hydroxide (CH)

Nanocalcium Hydroxide (NCH)

Experimental group

Description:

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.

Treatment:

Drug: Nanocalcium Hydroxide (NCH)