Enhancing Anaesthetic Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Comparative Randomized Controlled Trial

NCT ID: NCT06330519

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intraligamentary dexamethazone

Group Type EXPERIMENTAL

Dexamethasone sodium phosphate injection

Intervention Type DRUG

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

Endo-ice cryotherapy

Group Type ACTIVE_COMPARATOR

1,1,1,2 tetrafluoroethane

Intervention Type OTHER

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

Intraoral soft tissue cryotherapy

Group Type ACTIVE_COMPARATOR

intraoral soft tissue cryotherapy

Intervention Type OTHER

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

Inferior Alveolar nerve block only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexamethasone sodium phosphate injection

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

Intervention Type DRUG

1,1,1,2 tetrafluoroethane

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

Intervention Type OTHER

intraoral soft tissue cryotherapy

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

Intervention Type OTHER

Other Intervention Names

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Endo-ice

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ainshams University Dentistry

Identifier Type: -

Identifier Source: org_study_id

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