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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05666089

Enrollment

Registered

2022-12-27

Start date

2023-02-01

Completion date

2024-03-01

Last updated

2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calcium Hydroxide, Intracanal Medication, Mediators, N-acetylcystine

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.

Interventions

DRUGN-acetyl cysteine

intracanal medication of NAC with concentration 1 gm/ml in the form of a paste

DRUGCalcium hydroxide

intracanal medication of calcium hydroxide paste (metapaste)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Intensity of postoperative pain	6 hours post-instrumentation.	Intensity of postoperative pain will be measured using numerical rating scale (NRS)

Secondary

Measure	Time frame	Description
Bacterial load reduction	Sample 1 (S1): after access preparation and pre-instrumentation.	Bacterial counting using agar Culture technique
Periapical MMP-9 level	at 1st visit post- instrumentation.	using ELISA

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026