Clinical trial NCT05666089: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Intracanal Medication
N-acetylcystine
Calcium Hydroxide
Mediators
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intensity of postoperative pain
timeFrame: 6 hours post-instrumentation.
measure: Intensity of postoperative pain
timeFrame: 12 hours post-instrumentation
measure: Intensity of postoperative pain
timeFrame: 24 hours post-instrumentation
measure: Intensity of postoperative pain
timeFrame: 48 hours post-instrumentation
measure: Intensity of postoperative pain
timeFrame: 6 hours post-obturation.
measure: Intensity of postoperative pain
timeFrame: 12 hours post-obturation
measure: Intensity of postoperative pain
timeFrame: 24 hours post-obturation
measure: Intensity of postoperative pain
timeFrame: 48 hours post-obturation
Secondary outcomes:
measure: Bacterial load reduction
timeFrame: Sample 1 (S1): after access preparation and pre-instrumentation.
measure: Bacterial load reduction
timeFrame: Sample 2 (S2): at the end of 1st visit post-instrumentation.
measure: Bacterial load reduction
timeFrame: Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)
measure: Periapical MMP-9 level
timeFrame: at 1st visit post- instrumentation.
measure: Periapical MMP-9 level
timeFrame: after 2 weeks at 2nd visit (pre-obturation).
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: FACULTY OF DENTISTRY-cairo university
Study officials:
References: