NCT07738302

Brief Summary

Evaluation and comparing the effect of cryotherapy and dexamethasone on inflammatory mediators and post-operative pain in symptomatic irreversible pulpitis with acute apical periodontitis.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Aug 2026

Shorter than P25 for not_applicable

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

Study Progress1%
Aug 2026Sep 2026

First Submitted

Initial submission to the registry

July 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 26, 2026

Last Update Submit

July 26, 2026

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • post-operative pain

    VAS scale (visual analogue scale)

    7 days

Study Arms (4)

cold NaOCl , dexamethasone

EXPERIMENTAL

for 1st visit and cold saline as final rinse for 2nd visit

Combination Product: cold NaOCl , dexamethasone

NaOCl, dexamethasone

EXPERIMENTAL

for 1st visit and saline as final rinse for 2nd visit (room temperature)

Combination Product: NaOCl, dexamethasone

cold NaOCl and cold saline

EXPERIMENTAL

for both visits final rinse for 2nd visit

Combination Product: cold NaOCl and cold saline

NaOCl and saline

ACTIVE COMPARATOR

for both visits final rinse for 2nd visit (room temperature)

Combination Product: NaOCl and saline

Interventions

cold NaOCl , dexamethasoneCOMBINATION_PRODUCT

irrigation solution

cold NaOCl , dexamethasone
NaOCl, dexamethasoneCOMBINATION_PRODUCT

irrigation solution

NaOCl, dexamethasone
cold NaOCl and cold salineCOMBINATION_PRODUCT

irrigation solution

cold NaOCl and cold saline
NaOCl and salineCOMBINATION_PRODUCT

irrigation solution

NaOCl and saline

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Medically free Patients. (ASA I and II)
  • Age between 20-50 years old.
  • Males \& Females.
  • Patients' acceptance for participating in the trial through an informed consent (Appendix I)
  • Diagnosed clinically and radiographically with symptomatic irreversible pulpitis with apical peridontitits
  • No periapical radiolucency
  • Patent canals with n

You may not qualify if:

  • Non restorable teeth.
  • No bleeding upon conducting access preparation.
  • Teeth presenting with:
  • History of trauma or previous endodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexamethasoneSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

July 26, 2026

First Posted

July 31, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07