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NCT Number: NCT06330519

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

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.

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Key information

Conditions

Pulpitis - Irreversible

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexamethasone sodium phosphate injection

Drug

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

1,1,1,2 tetrafluoroethane

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

Other names: Endo-ice

intraoral soft tissue cryotherapy

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

Primary outcomes

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

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

    Percentage of the successful participants among total participants

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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