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

Early Phase 1

Not yet recruiting

• Conditions: Calcium Hydroxide; N-acetylcystine; Mediators; Intracanal Medication
• Interventions: Drug: Calcium hydroxide; Drug: N-acetyl cysteine

• Registration Number: NCT05666089
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-16
• Last Update Submitted: 2022-12-16
• Study First Posted: 2022-12-27
• Last Update Posted: 2022-12-27
• Study Start: 2023-02-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium hydroxide	Calcium hydroxide	intracanal medication of Ca(OH)2 paste
N-acetylcysteine	N-acetyl cysteine	intracanal medication of NAC paste

Primary Outcome Measures

Name	Time	Method
Intensity of postoperative pain	48 hours post-obturation	Intensity of postoperative pain will be measured using numerical rating scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Bacterial load reduction	Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)	Bacterial counting using agar Culture technique
Periapical MMP-9 level	after 2 weeks at 2nd visit (pre-obturation).	using ELISA

Trial Locations

Locations (1)

FACULTY OF DENTISTRY-cairo university; 🇪🇬 Cairo, Egypt