NCT07453160

Brief Summary

Brief Summary (A short description for the lay public) This study aims to find out if the type of cleaning solution used during a root canal affects the pain a patient feels the next day. A root canal procedure involves cleaning the inside of the tooth. Two common cleaning solutions are chlorhexidine (CHX) and sodium hypochlorite (NaOCl, also known as bleach). While both are effective, it is not clear if one causes more discomfort than the other. In this research, half of the participants will have their root canal cleaned with CHX, and the other half with NaOCl. We will then ask all participants to rate their pain 24 hours after the procedure using a simple pain scale. Our goal is to see if there is a difference in pain levels between the two groups. The results will help dentists choose the best solution to make their patients more comfortable after treatment

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable postoperative-pain

Status
not yet recruiting

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

February 12, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 12, 2026

Last Update Submit

March 3, 2026

Conditions

Keywords

Postoperative painRoot canal treatment

Outcome Measures

Primary Outcomes (2)

  • Postoperative pain intensity at 24 hours

    Pain intensity measured using a 4-point Visual Analog Scale (VAS): 0 = no pain, 1 = mild pain, 2 = moderate pain (required analgesics with relief), 3 = severe pain (analgesics no relief). Patient-reported 24 hours post-treatment.

    24 hours after root canal treatment completion

  • Postoperative pain intensity at 24 hours

    Pain intensity measured using a 4-point Visual Analog Scale (VAS): 0 = no pain, 1 = mild pain, 2 = moderate pain (required analgesics with relief), 3 = severe pain (analgesics no relief). Patient-reported 24 hours post-treatmen

    24 hours after root canal treatment completion

Study Arms (2)

2% Chlorhexidine Group

EXPERIMENTAL

Root canal irrigation with 2% chlorhexidine gluconate solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min.

Procedure: Chlorhexidine gluconate 2%Drug: Sodium hypochlorite 5.25%

5.25% Sodium Hypochlorite Group

ACTIVE COMPARATOR

Root canal irrigation with 5.25% sodium hypochlorite solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min.

Procedure: Chlorhexidine gluconate 2%Drug: Sodium hypochlorite 5.25%

Interventions

2% chlorhexidine gluconate solution used as root canal irrigant. Clear, colorless, odorless liquid. Broad-spectrum antimicrobial with substantivity (binds to dental tissues, prolonged effect up to 72 hours). Does not dissolve organic tissue. Lower cytotoxicity than NaOCl. Applied at 2 mL per instrument, delivered via 27-gauge side-vented Max-i-Probe needle placed 1-2 mm short of working length, passive flow at 2-4 mL/min, continuous needle motion. Room temperature. Final irrigation with same solution

2% Chlorhexidine Group5.25% Sodium Hypochlorite Group

5.25% sodium hypochlorite solution used as root canal irrigant. Pale yellow liquid with characteristic chlorine odor. Broad-spectrum antimicrobial with rapid bactericidal action. Dissolves organic pulp tissue and necrotic debris. Cytotoxic to periapical tissues if extruded. No substantivity. Applied at 2 mL per instrument, delivered via 27-gauge side-vented Max-i-Probe needle placed 1-2 mm short of working length, passive flow at 2-4 mL/min, continuous needle motion. Room temperature. Final irrigation with same solution.

2% Chlorhexidine Group5.25% Sodium Hypochlorite Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-65 years
  • Any gender
  • Requiring non-surgical root canal treatment
  • Willing to provide written informed consent
  • Able to report postoperative pain using a validated pain assessment scale -

You may not qualify if:

  • Systemic conditions affecting pain perception (e.g., diabetes with neuropathy, fibromyalgia)
  • Medications affecting pain perception (e.g., chronic analgesics, corticosteroids, antidepressants)
  • Preoperative dental pain in the tooth scheduled for treatment
  • Pregnancy or lactation
  • Teeth with resorbed roots
  • Mobile teeth (pathological mobility)
  • Open apices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Faiz Rahman, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Resident, Department of Operative Dentistry

Study Record Dates

First Submitted

February 12, 2026

First Posted

March 5, 2026

Study Start

February 15, 2026

Primary Completion

June 15, 2026

Study Completion

June 15, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03