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

Phase 4

Completed

• Conditions: Pulpitis - Irreversible
• Interventions: Drug: Dexamethasone sodium phosphate injection; Other: 1,1,1,2 tetrafluoroethane; Other: intraoral soft tissue cryotherapy

• Registration Number: NCT06330519
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Status Verified: 2024-03
• Primary Completion: 2024-03-01
• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Study Completion: 2024-03-30
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intraligamentary dexamethazone	Dexamethasone sodium phosphate injection	-
Endo-ice cryotherapy	1,1,1,2 tetrafluoroethane	-
Intraoral soft tissue cryotherapy	intraoral soft tissue cryotherapy	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt