NCT07852260

Brief Summary

The objective of this study is to evaluate the postoperative pain and antimicrobial efficacy when using super-oxidized water (Microcyn) and 2% Chlorhexidine as irrigating solutions in comparison to 2.5% Sodium hypochlorite in teeth with asymptomatic necrotic pulps.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 2, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 25, 2026

Last Update Submit

September 25, 2026

Conditions

Keywords

Postoperative pain, NRS, Bacterial load reduction

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity at 6 hours post-instrumentation

    A pain chart using numerical rating scale (NRS) will then be used to record the patients' pain level. The NRS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain.

    6 hours post-instrumentation

Study Arms (3)

Group A

ACTIVE COMPARATOR

Each canal will receive 2ml of super-oxidized water (Microcyn) irrigating solution between each instrument size and the subsequent one.

Other: super-oxidized water (Microcyn) irrigating solution

Group B

ACTIVE COMPARATOR

Each canal will receive 2ml of 2% chlorhexidine irrigating solution between each instrument size and the subsequent one.

Other: 2% chlorhexidine irrigating solution

Group C

ACTIVE COMPARATOR

Each canal will receive 2ml of 2.5 % sodium hypochlorite irrigating solution between each instrument size and the subsequent one.

Other: 2.5% sodium hypochlorite

Interventions

The difference in concentration of chlorine between NaOCl and super oxidized water such that the concentration of chlorine ions in NaOCl is much higher than that in super-oxidized water. However, considering the 90% reduction in biofilm thickness and 98% reduction in colony count of microorganisms by super-oxidized water as demonstrated

Group A

Chlorhexidine (CHX) has been indicated as an alternative irrigation agent in the preparation of the root canal system, due to its broad-spectrum antimicrobial capacity, dentin tubule disinfection, dentin adsorption, high substantivity, and low toxicity compared to NaOCl. The inability to dissolve organic tissues of the CHX provides controversial in the use of this irrigant, and due to this limitation, some authors do not indicate it as the main irrigation solution in endodontic treatment despite its utility as a final irrigation solution.

Group B

Sodium hypochlorite (NaOCl) is the most common and has been widely used in endodontics for more than 70 years because of its ability to act as a solvent for organic matter and its efficient antimicrobial action, however, at high concentrations, it is likely to irritate periradicular tissues.

Group C

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II.
  • Patients whose age ranges between 18 and 50 years.
  • Male and female patients.
  • Patients having a single canal-tooth with asymptomatic necrotic pulp.
  • Patients who can understand the number rating scale.
  • Patients who accept to participate in the trial and can sign the informed consent

You may not qualify if:

  • Pregnant females.
  • Patients with intraoral or extraoral swelling.
  • Patients whose tooth is non-restorable.
  • Teeth with open apices.
  • Teeth with radiographic evidence of root resorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of Dentistry Cairo university

Cairo, Cairo Governorate, 11553, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Central Study Contacts

Paunceh S Soliman, PHD candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
-In this proposed study, both the participant and assessor will be blinded. This is achieved where the outcome assessor will not be informed of the group in which the participant is enrolled for subjective outcomes. The participants will be blinded to the study hypothesis as to which intervention is expected to be better. * The patients who already do not know their treatment group will assess the level of their postoperative pain. * The laboratory technician at the microbiological department will not know the treatment group of the patients. * The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Group A: Each canal will receive 2ml of super-oxidized water (Microcyn) irrigating solution between each instrument size and the subsequent one. Group B: Each canal will receive 2ml of 2% chlorhexidine irrigating solution between each instrument size and the subsequent one. Group C: Each canal will receive 2ml of 2.5 % sodium hypochlorite irrigating solution between each instrument size and the subsequent one.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD candidate

Study Record Dates

First Submitted

September 25, 2026

First Posted

October 1, 2026

Study Start (Estimated)

November 2, 2026

Primary Completion (Estimated)

November 2, 2027

Study Completion (Estimated)

November 2, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) with other researchers due to participant confidentiality and privacy considerations.

Locations