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

Impact of Different Techniques on the Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis: A Randomized Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06330519

Enrollment

188

Registered

2024-03-26

Start date

2023-02-01

Completion date

2024-03-30

Last updated

2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulpitis - Irreversible

Keywords

dexamethasone, intraligamentary, cryotherapy

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.

Interventions

DRUGDexamethasone sodium phosphate injection

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

OTHER1,1,1,2 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

OTHERintraoral 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The effect of intraligamentary dexamethazone injection on the success rate of inferior alveolar nerve block	Assessed up to 30 minutes, from lip numbness point until the end of pulp extirpation.	Percentage of the successful participants among total participants

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026