NCT05666089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2023

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 27, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

December 9, 2022

Last Update Submit

December 16, 2022

Conditions

Intracanal MedicationN-acetylcystineCalcium HydroxideMediators

Outcome Measures

Primary Outcomes (8)

  • Intensity of postoperative pain

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

    6 hours post-instrumentation.

  • Intensity of postoperative pain

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

    12 hours post-instrumentation

  • Intensity of postoperative pain

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

    24 hours post-instrumentation

  • Intensity of postoperative pain

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

    48 hours post-instrumentation

  • Intensity of postoperative pain

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

    6 hours post-obturation.

  • Intensity of postoperative pain

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

    12 hours post-obturation

  • Intensity of postoperative pain

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

    24 hours post-obturation

  • Intensity of postoperative pain

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

    48 hours post-obturation

Secondary Outcomes (5)

  • Bacterial load reduction

    Sample 1 (S1): after access preparation and pre-instrumentation.

  • Bacterial load reduction

    Sample 2 (S2): at the end of 1st visit post-instrumentation.

  • Bacterial load reduction

    Sample 3 (S3): after 2 weeks intracanal medicament placement (pre-obturation)

  • Periapical MMP-9 level

    at 1st visit post- instrumentation.

  • Periapical MMP-9 level

    after 2 weeks at 2nd visit (pre-obturation).

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

intracanal medication of NAC paste

Drug: N-acetyl cysteine

Calcium hydroxide

ACTIVE COMPARATOR

intracanal medication of Ca(OH)2 paste

Drug: Calcium hydroxide

Interventions

N-acetyl cysteineDRUG

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

N-acetylcysteine
Calcium hydroxideDRUG

intracanal medication of calcium hydroxide paste (metapaste)

Calcium hydroxide

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FACULTY OF DENTISTRY-cairo university

Cairo, Egypt

Location

MeSH Terms

Interventions

AcetylcysteineCalcium Hydroxide

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsHydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

December 9, 2022

First Posted

December 27, 2022

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

December 27, 2022

Record last verified: 2022-12

Locations

EG(1)