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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

Primary Purpose

Intracanal Medication, N-acetylcystine, Calcium Hydroxide

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
N-acetyl cysteine
Calcium hydroxide
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracanal Medication

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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: Medically compromised patients. Pregnant women Patients undergoing previous endodontic treatment or analgesics and/or antibiotics have been administrated by the patient during the past 24 hours preoperatively. Patients reporting bruxism or clenching. Teeth that show association with acute periapical abscess and swelling. Greater than grade I mobility or pocket depth greater than 5mm. Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam Teeth with vital pulp. Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.

Sites / Locations

  • FACULTY OF DENTISTRY-cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

N-acetylcysteine

Calcium hydroxide

Arm Description

intracanal medication of NAC paste

intracanal medication of Ca(OH)2 paste

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bacterial load reduction
Bacterial counting using agar Culture technique
Bacterial load reduction
Bacterial counting using agar Culture technique
Bacterial load reduction
Bacterial counting using agar Culture technique
Periapical MMP-9 level
using ELISA
Periapical MMP-9 level
using ELISA

Full Information

First Posted
December 9, 2022
Last Updated
December 16, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05666089
Brief 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
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracanal Medication, N-acetylcystine, Calcium Hydroxide, Mediators

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
intracanal medication of NAC paste
Arm Title
Calcium hydroxide
Arm Type
Active Comparator
Arm Description
intracanal medication of Ca(OH)2 paste
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Intervention Description
intracanal medication of NAC with concentration 1 gm/ml in the form of a paste
Intervention Type
Drug
Intervention Name(s)
Calcium hydroxide
Intervention Description
intracanal medication of calcium hydroxide paste (metapaste)
Primary Outcome Measure Information:
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
6 hours post-instrumentation.
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
12 hours post-instrumentation
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
24 hours post-instrumentation
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
48 hours post-instrumentation
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
6 hours post-obturation.
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
12 hours post-obturation
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
24 hours post-obturation
Title
Intensity of postoperative pain
Description
Intensity of postoperative pain will be measured using numerical rating scale (NRS)
Time Frame
48 hours post-obturation
Secondary Outcome Measure Information:
Title
Bacterial load reduction
Description
Bacterial counting using agar Culture technique
Time Frame
Sample 1 (S1): after access preparation and pre-instrumentation.
Title
Bacterial load reduction
Description
Bacterial counting using agar Culture technique
Time Frame
Sample 2 (S2): at the end of 1st visit post-instrumentation.
Title
Bacterial load reduction
Description
Bacterial counting using agar Culture technique
Time Frame
Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)
Title
Periapical MMP-9 level
Description
using ELISA
Time Frame
at 1st visit post- instrumentation.
Title
Periapical MMP-9 level
Description
using ELISA
Time Frame
after 2 weeks at 2nd visit (pre-obturation).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Medically compromised patients. Pregnant women Patients undergoing previous endodontic treatment or analgesics and/or antibiotics have been administrated by the patient during the past 24 hours preoperatively. Patients reporting bruxism or clenching. Teeth that show association with acute periapical abscess and swelling. Greater than grade I mobility or pocket depth greater than 5mm. Non-restorable teeth or teeth that could not be adequately isolated with a rubber dam Teeth with vital pulp. Immature teeth. Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
Facility Information:
Facility Name
FACULTY OF DENTISTRY-cairo university
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Safwa Es. Abd Elglil, MSc. (cairo university)
Phone
01001259618
Email
safwaessam91@GMAIL.COM

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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