NCT06834711

Brief Summary

The goal of this clinical study was to evaluate the effect of using different irrigation solutions in the final irrigation of root canal treatment procedures on the intensity of postoperative pain and periapical tissue healing in patients presenting with mandibular molars with chronic apical periodontitis. The main question it aims to answer is: \- Does controlled irrigation with chlorhexidin and N-asetil sistein in root canal treatment reduce the severity of postoperative pain? In the chlorhexidin group, unlike the control group, each root canal was irrigated with 3 mL %2 chlorhexidin solution in the final irrigation. In the N-asetil sistein group, unlike the control group, each root canal was irrigated with 3 mL 200 mg/ml N-asetil sistein solution in the final irrigation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed
Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

10 months

First QC Date

February 14, 2025

Last Update Submit

February 19, 2025

Conditions

Keywords

chronic apical periodontitispostoperative painN-asetil sisteminchlorhexidin

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain (10) imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. It may be used to help choose the right dose of pain medicine. Also called VAS.

    up to 72 hours

Study Arms (3)

Control Group

NO INTERVENTION

During root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% sodium hypochlorite (NaOCl). In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, 5 ml of 2.5% NaOCl was irrigated, and finally 5 ml of distilled water was used.

Chlorhexidine Group

EXPERIMENTAL

During root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% NaOCl. In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, each canal was irrigated with 3 ml of 2% chlorhexidine (CHX) and finally 5 ml of distilled water was used.

Drug: Chlorhexidine

N-asetil Sistein Group

EXPERIMENTAL

During root canal preparation, each canal was irrigated with a total of 18 ml of 2.5% NaOCl. In the final irrigation, each root canal was irrigated with 3 ml of 17% ethylene diamine tetra-acetic acid (EDTA) for 1 minute, followed by 5 ml of distilled water. Then, each canal was irrigated with 3 ml of N-acetyl Cysteine (NAC) (200 mg/ml) and finally 5 ml of distilled water was used.

Drug: N-Acetyl Cysteine

Interventions

The root canals were irrigated with 3 mL N-acetyl Cysteine (NAC)(200 mg/ml) in N-acetyl Cysteine group in the final irrigation.

N-asetil Sistein Group

The root canals were irrigated with 3 ml %2 chlorhexidine in chlorhexidin group in the final irrigation.

Chlorhexidine Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mandibular permanent molars with chronic apical periodontitis
  • Teeth with periapical index (PAI) score greater than 2
  • Teeth with periodontal pocket depth less than 3 mm
  • Patients without systemic disease (ASA 1-2)

You may not qualify if:

  • Patients who have used analgesic, anti-inflammatory or opioid drugs in the last 7 days or antibiotics in the last 3 months
  • Patients who report pregnancy, lactation or psychiatric disorders
  • Teeth with a history of root canal treatment, sinus tract or abscess, and teeth planned for prosthetic restoration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Sarıçam, 01250, Turkey (Türkiye)

Location

Related Publications (2)

  • Corazza BJM, Martinho FC, Khoury RD, Toia CC, Orozco EIF, Prado RF, Machado FP, Valera MC. Clinical influence of calcium hydroxide and N-acetylcysteine on the levels of resolvins E1 and D2 in apical periodontitis. Int Endod J. 2021 Jan;54(1):61-73. doi: 10.1111/iej.13403. Epub 2020 Oct 3.

    PMID: 32896000BACKGROUND
  • Comparative evaluation of N-acetylcysteine and chlorhexidine as final irrigation on the push-out bond strength of different sealers: An in vitro study

    BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AcetylcysteineChlorhexidine

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 ProteinsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cukurova University, Faculty of Dentistry

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 19, 2025

Study Start

February 15, 2024

Primary Completion

December 12, 2024

Study Completion

January 5, 2025

Last Updated

February 20, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations