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

Calcium Hydroxide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666089
• Other study ID #: safwaendo91
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calcium Hydroxide
• Dental Pulp Necrosis
• Pain, Postoperative

Intervention

Drug:
• N-acetyl cysteine
intracanal medication of NAC with concentration 1 gm/ml in the form of a paste
• Calcium hydroxide
intracanal medication of calcium hydroxide paste (metapaste)

Locations

Country	Name	City	State
Egypt	FACULTY OF DENTISTRY-cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	6 hours post-instrumentation.
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	12 hours post-instrumentation
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	24 hours post-instrumentation
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	48 hours post-instrumentation
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	6 hours post-obturation.
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	12 hours post-obturation
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	24 hours post-obturation
Primary	Intensity of postoperative pain	Intensity of postoperative pain will be measured using numerical rating scale (NRS)	48 hours post-obturation
Secondary	Bacterial load reduction	Bacterial counting using agar Culture technique	Sample 1 (S1): after access preparation and pre-instrumentation.
Secondary	Bacterial load reduction	Bacterial counting using agar Culture technique	Sample 2 (S2): at the end of 1st visit post-instrumentation.
Secondary	Bacterial load reduction	Bacterial counting using agar Culture technique	Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)
Secondary	Periapical MMP-9 level	using ELISA	at 1st visit post- instrumentation.
Secondary	Periapical MMP-9 level	using ELISA	after 2 weeks at 2nd visit (pre-obturation).