NCT06330519

Brief Summary

The goal of this clinical trial is to assess the effect of

  • Preoperative intraligamentary corticosteroids injection
  • Cryotherapy which is cold application on :
  • Hard tooth structure ( crown of the tooth )
  • Soft tissue overlying roots on the efficacy of the inferior alveolar nerve block anaesthesia in patients with mandibular molars with symptomatic irreversible pulpitis. The main question it aims to answer are: • Does intraligamentary dexamethazone injection increase the success rate of inferior alveolar nerve block without the need for oral premedication. Participants will describe their preoperative pain level to the investigator and describe their pain level during the treatment. Researchers will compare cryotherapy to see if it increases the success rate of inferior alveolar nerve block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

May 9, 2025

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

March 8, 2024

Last Update Submit

May 6, 2025

Conditions

Pulpitis - Irreversible

Keywords

dexamethasoneintraligamentarycryotherapy

Outcome Measures

Primary Outcomes (1)

  • The effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block

    Percentage of the successful participants among total participants

    Assessed up to 30 minutes, from lip numbness point until the end of pulp extirpation.

Study Arms (4)

intraligamentary dexamethazone

EXPERIMENTAL
Drug: Dexamethasone sodium phosphate injection

Endo-ice cryotherapy

ACTIVE COMPARATOR
Other: 1,1,1,2 tetrafluoroethane

Intraoral soft tissue cryotherapy

ACTIVE COMPARATOR
Other: intraoral soft tissue cryotherapy

Inferior Alveolar nerve block only

NO INTERVENTION

Interventions

Dexamethasone sodium phosphate injectionDRUG

Patients receive 0.8ml of dexamethazone by periodontal ligament injection 30 minutes before the inferior alveolar nerve block

intraligamentary dexamethazone
1,1,1,2 tetrafluoroethaneOTHER

EndoIce (1,1,1,2 tetrafluoroethane) applied on the buccal, lingual (3 s/surface), and occlusal surfaces (4 s) for a total of 10 s then standard IANB was administered

Also known as: Endo-ice
Endo-ice cryotherapy
intraoral soft tissue cryotherapyOTHER

Small ice packs (wrapped in sterile gauze) placed intraorally in the mouth on the vestibular surface of the treated tooth for 5 minutes then standard IANB was administered

Intraoral soft tissue cryotherapy

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
  • Having a mandibular molar tooth diagnosed with symptomatic irreversible pulpitis (hot tooth - vital pulp, intermittent or continuous sharp pain that lasts longer after removal of the stimulus).

You may not qualify if:

  • Presence of any systemic disease or allergic reactions.
  • Vulnerable group; prisoners, pregnant females, mentally ill, etc…
  • The presence of a periapical radiolucency.
  • Teeth with open apices.
  • A previous root canal treatment.
  • Sinus tracts.
  • Local gum swelling around the affected tooth.
  • Severe periodontal disease .
  • Presence of periodontal pockets \>3 mm in the affected tooth.
  • Absence of bleeding in the pulp chamber on access cavity preparation.
  • Patients with doubted diagnosis due to multiple carious teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

dexamethasone 21-phosphatenorfluraneDental Pulp Test

Intervention Hierarchy (Ancestors)

Diagnosis, OralDentistry

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2024

First Posted

March 26, 2024

Study Start

February 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 30, 2024

Last Updated

May 9, 2025

Record last verified: 2024-03

Locations

EG(1)