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N-acetylcysteine for Root Canal Treatment of Necrotic Teeth With Apical Periodontitis

NCT ID: NCT07262554

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-15

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Apical Periodontitis

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Calcium hydroxide (Ca(OH)₂)

UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days

Group Type ACTIVE_COMPARATOR

Calcium hydroxide (Ca(OH)₂)

Intervention Type DRUG

UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days

N-acetylcysteine (NAC)

N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days

Group Type EXPERIMENTAL

N-Acetylcysteine (NAC)

Intervention Type DRUG

N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days

Interventions

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Calcium hydroxide (Ca(OH)₂)

UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days

Intervention Type DRUG

N-Acetylcysteine (NAC)

N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days

Intervention Type DRUG

Other Intervention Names

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Acetylcysteine N-Acetyl-L-cysteine

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Mai Hussein

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PACTR202511513893768

Identifier Type: REGISTRY

Identifier Source: secondary_id

9258326

Identifier Type: -

Identifier Source: org_study_id