Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp

Effect of N-acetylcysteine Versus Calcium Hydroxide Used as an Intracanal Medicament on the Intensity of Postoperative Pain, Bacterial Load Reduction and Levels of MMP -9 in Periapical Fluids in Patients With Necrotic Pulp: A Randomized Clinical Trial

To compare the effect of N-acetylcysteine versus calcium hydroxide as intra canal medication on:

• Intensity of postoperative pain.
• Bacterial load reduction.
• levels of MMP -9 in Periapical Fluids.

Study Overview

• Status: Not yet recruiting
• Conditions: Calcium Hydroxide; Intracanal Medication; N-acetylcystine; Mediators
• Intervention / Treatment: Drug: N-acetyl cysteine; Drug: Calcium hydroxide

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry-Cairo University
    • Contact: Safwa Es. Abd Elglil, MSc. (cairo university); Phone Number: 01001259618; Email: safwaessam91@GMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are free from any physical or mental handicapping condition.

• Males & Females with

  • Mandibular single rooted permanent premolar teeth.
  • Absence of spontaneous pain.
  • Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
• Patients' acceptance to participate in the trial.
• Patients who can understand pain scale and can sign the informed consent (Appendix I)

Exclusion Criteria:

1. Medically compromised patients.
2. Pregnant women
3. Patients undergoing previous endodontic treatment or analgesics and/or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
4. Patients reporting bruxism or clenching.
5. Teeth that show association with acute periapical abscess and swelling.
6. Greater than grade I mobility or pocket depth greater than 5mm.
7. Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam
8. Teeth with vital pulp.
9. Immature teeth.
10. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N-acetylcysteine; intracanal medication of NAC paste	Drug: N-acetyl cysteine; intracanal medication of NAC with concentration 1 gm/ml in the form of a paste
Active Comparator: Calcium hydroxide; intracanal medication of Ca(OH)2 paste	Drug: Calcium hydroxide; intracanal medication of calcium hydroxide paste (metapaste)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	6 hours post-instrumentation.
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	12 hours post-instrumentation
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	24 hours post-instrumentation
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	48 hours post-instrumentation
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	6 hours post-obturation.
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	12 hours post-obturation
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	24 hours post-obturation
Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	48 hours post-obturation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial load reduction	Bacterial counting using agar Culture technique	Sample 1 (S1): after access preparation and pre-instrumentation.
Bacterial load reduction	Bacterial counting using agar Culture technique	Sample 2 (S2): at the end of 1st visit post-instrumentation.
Bacterial load reduction	Bacterial counting using agar Culture technique	Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)
Periapical MMP-9 level	using ELISA	at 1st visit post- instrumentation.
Periapical MMP-9 level	using ELISA	after 2 weeks at 2nd visit (pre-obturation).

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pain, Postoperative; Dental Pulp Necrosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Calcium-Regulating Hormones and Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Calcium; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: safwaendo91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No