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

A

Alexandria University

Status and phase

Active, not recruiting
Phase 2

Conditions

Apical Periodontitis

Treatments

Drug: N-Acetylcysteine (NAC)
Drug: Calcium hydroxide (Ca(OH)₂)

Study type

Interventional

Funder types

Other

Identifiers

NCT07262554
PACTR202511513893768 (Registry Identifier)
9258326

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Calcium hydroxide (Ca(OH)₂)
Active Comparator group
Description:
UltraCal XS calcium hydroxide (Ca(OH)₂) intracanal medication for 7 days
Treatment:
Drug: Calcium hydroxide (Ca(OH)₂)
N-acetylcysteine (NAC)
Experimental group
Description:
N-acetylcysteine (NAC) intracanal medication for 7 days and 600 mg/day oral NAC for 21 days
Treatment:
Drug: N-Acetylcysteine (NAC)

Trial contacts and locations

1

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Central trial contact

Mahmoud R Aboelseoud, PhD (Endo); Mai M Hussein, MSc (Endo)

Data sourced from clinicaltrials.gov

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