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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07057336
Enrollment
90
Registered
2025-07-09
Start date
2024-05-14
Completion date
2025-12-20
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Apical Periodontitis

Keywords

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

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.

Interventions

DRUGConventional 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. 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.

DRUGNanocalcium 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. The cavity was sealed temporarily with a sterile cotton pellet and glass ionomer cement. Nanocalcium hydroxide was retained for 7 days before final obturation.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale (VAS)up to 72 hoursThe 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORHamdi Oğuz Yoldaş, DDS PHD

Cukurova University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026