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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05666089
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracanal Medication; N-acetylcystine; Calcium Hydroxide; Mediators	Drug: N-acetyl cysteine; Drug: Calcium hydroxide	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Intensity of postoperative pain [6 hours post-instrumentation.]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

2. Intensity of postoperative pain [12 hours post-instrumentation]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

3. Intensity of postoperative pain [24 hours post-instrumentation]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

4. Intensity of postoperative pain [48 hours post-instrumentation]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

5. Intensity of postoperative pain [6 hours post-obturation.]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

6. Intensity of postoperative pain [12 hours post-obturation]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

7. Intensity of postoperative pain [24 hours post-obturation]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

8. Intensity of postoperative pain [48 hours post-obturation]

   Intensity of postoperative pain will be measured using numerical rating scale (NRS)

Secondary Outcome Measures

1. Bacterial load reduction [Sample 1 (S1): after access preparation and pre-instrumentation.]

   Bacterial counting using agar Culture technique

2. Bacterial load reduction [Sample 2 (S2): at the end of 1st visit post-instrumentation.]

   Bacterial counting using agar Culture technique

3. Bacterial load reduction [Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)]

   Bacterial counting using agar Culture technique

4. Periapical MMP-9 level [at 1st visit post- instrumentation.]

   using ELISA

5. Periapical MMP-9 level [after 2 weeks at 2nd visit (pre-obturation).]

   using ELISA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FACULTY OF DENTISTRY-cairo university	Cairo		Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Safwa Essam Mohammed Ahmed Abd el-glil, Assistant lecturer, Cairo University
• ClinicalTrials.gov Identifier: NCT05666089
• Other Study ID Numbers: safwaendo91
• First Posted: Dec 27, 2022
• Last Update Posted: Dec 27, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dental Pulp Necrosis; Pain, Postoperative; Acetylcysteine; Calcium; N-monoacetylcystine

Study Results

No Results Posted as of Dec 27, 2022