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| ID | Type | Description | Link |
|---|---|---|---|
| PACTR202511513893768 | Registry Identifier | The Pan African Clinical Trial Registry (PACTR) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium hydroxide (Ca(OH)₂) | Active Comparator | UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days |
|
| N-acetylcysteine (NAC) | Experimental | N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium hydroxide (Ca(OH)₂) | Drug | UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity | 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." | 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. |
| Assessment of periapical healing | 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. | A CBCT scan will be taken preoperatively and at six months follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the level of periapical tissues biomarkers | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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| ID | Term |
|---|---|
| D002126 | Calcium Hydroxide |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D017610 | Calcium Compounds |
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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.
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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.
| N-Acetylcysteine (NAC) | Drug | N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days |
|
|
| Samples will be collected from the periapical tissue fluid at two different points: before (S1) and after 7 days of administration of medications (S2). |
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000838 |
| Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |