Apical Periodontitis
Conditions
Keywords
N-acetylcysteine (NAC), Calcium hydroxide (Ca(OH)₂), Intracanal medication, Root canal treatment, Apical periodontitis, Postoperative pain, Periapical healing, Periapical tissue biomarkers, Cone-beam computed tomography (CBCT)
Brief summary
A randomized controlled trial comparing the postoperative pain intensity, periapical biomarkers level, and periapical healing in patients with necrotic mature teeth and apical periodontitis treated with N-acetylcysteine (NAC), as an intracanal and adjunctive systemic medication, versus calcium hydroxide (Ca(OH)₂) intracanal medication alone.
Interventions
DRUGCalcium hydroxide (Ca(OH)₂)
UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days
DRUGN-Acetylcysteine (NAC)
N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Two blinded and trained researchers, not involved in the intervention, will independently assess the pre- and postoperative radiographs. A blinded assessor will also perform the data analysis.
Intervention model description
Participants will be randomly assigned to one of two groups. Group I (control group): UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days; and Group II: N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days.
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Mature necrotic teeth. * Radiographic evidence of periapical bone loss. * Teeth that require primary endodontic treatment. * Restorable teeth.
Exclusion criteria
* Immature teeth * Teeth that had been previously accessed or endodontically treated. * Teeth with periodontal pockets deeper than 4 mm. * Patients with acute apical abscess. * Patients with systemic diseases. * Pregnant females. * Patients who received antibiotic therapy within the past month. * Patient on analgesics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | Pain will be recorded before the intervention, and patients will use the Numerical Rating Scale (NRS) to self-assess postoperative pain at 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, and 1 week. | Postoperative pain will be assessed using the Numerical Rating Scale (NRS), which is a scale from 0 (no pain) to 10 (worst pain imaginable). Patients will be asked to choose the number that represents their pain intensity. Pain level will be assigned as follows: 0, no pain; 1-3, mild pain; 4-6, moderate pain; 7-10, severe pain. |
| Assessment of periapical healing | A CBCT scan will be taken preoperatively and at six months follow-up. | Assessment of the percentage change in lesion volume through three-dimensional (3D) reconstruction of the lesions in Cone beam computed tomographic (CBCT) scans performed preoperatively and after a six-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the level of periapical tissues biomarkers | Samples will be collected from the periapical tissue fluid at two different points: before (S1) and after 7 days of administration of medications (S2). | The biomarker levels will be measured using enzyme-linked immunosorbent assay \[ELISA\]. Samples of periapical tissue fluid will be taken by inserting three sterile paper points into the root canal, about 2 mm beyond the working length, and holding them in place for 1 minute. The paper points will be transferred to a 1.5-mL Eppendorf and stored at -80°C until further analysis. |
Countries
Egypt
Outcome results
None listed