NCT07340944

Brief Summary

This study aimed to evaluate the efficacy of N-acetylcysteine (NAC) used as an intracanal medicament on antibacterial activity, periapical RANKL/OPG ratio, and postoperative pain levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 6, 2026

Last Update Submit

January 14, 2026

Conditions

Chronic Apical Periodontitis

Keywords

N-acetylcysteinecalcium hydroxidedouble antibiotic pasteintracanal medicamentRANKLosteoprotegerinpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Antibacterial efficacy of intracanal medicaments, RANKL/OPG ratio and effect on postoperative pain

    The antibacterial activity of intracanal medicaments will be measured by PCR analysis, Rankl/opg ratio will be measured by ELISA analysis and postoperative level will be measured by VAS.

    The medication will remain in the canal for one week. Patients will receive treatment within one month.

Study Arms (3)

N-acetylcysteine group

EXPERIMENTAL

NAC was placed into the root canal as an intracanal medication.

Drug: N Acetyl Cysteine

Calcium Hydroxide Group

ACTIVE COMPARATOR

Ca(OH)2 was placed into the root canal as an intracanal medication.

Drug: Calcium Hydroxide (Ca(OH)2)

Double Antibiotic Paste Group

ACTIVE COMPARATOR

DAP was placed into the root canal as an intracanal medication.

Drug: Double Antibiotic Paste

Interventions

N Acetyl CysteineDRUG

NAC was placed into the root canal as an intracanal medication. The medication was removed after one week. Root canal treatment was completed. Treatment was completed for 15 patients in the group within one month.

N-acetylcysteine group
Calcium Hydroxide (Ca(OH)2)DRUG

Ca(OH)2 was placed into the root canal as an intracanal medication. The medication was removed after one week. Root canal treatment was completed. Treatment was completed for 15 patients in the group within one month.

Calcium Hydroxide Group
Double Antibiotic PasteDRUG

DAP was placed into the root canal as an intracanal medication. The medication was removed after one week. Root canal treatment was completed. Treatment was completed for 15 patients in the group within one month.

Double Antibiotic Paste Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-vital teeth confirmed by clinical and pulp sensitivity tests
  • Teeth with a single canal and diagnosed with asymptomatic apical periodontitis
  • Periapical assessment (PAI) of 2 or greater
  • Teeth with a pocket depth not exceeding 3 mm
  • Teeth without excessive root curvature (Schneider class 1) and with visible root canals on radiographs
  • Permanent teeth with complete root development
  • Patients between the ages of 18 and 65
  • Teeth without previous endodontic treatment

You may not qualify if:

  • Patients who refused to participate in the study
  • Patients with any systemic disease
  • Patients who received antibiotic treatment within the last 3 months
  • Patients who were pregnant or suspected of being pregnant
  • Teeth with excessive crown damage that would not allow for the placement of a rubber dam
  • Teeth with root fractures, pathological findings or mobility,
  • Presence of any resorption in the involved tooth,
  • Patients with active swelling and tenderness to palpation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AcetylcysteineCalcium Hydroxide

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsHydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • Ceren Yeniay

    Ataturk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

September 10, 2022

Primary Completion

January 9, 2023

Study Completion

May 15, 2024

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)