Impact of Different Techniques on The Efficacy of Anaesthesia in Mandibular Molars With Acute Irreversible Pulpitis

Pulpitis - Irreversible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06330519
• Other study ID #: Ainshams University Dentistry
• Status: Completed
• Phase: Phase 4
• Start date: September 25, 2023
• Est. completion date: February 21, 2024

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• Dexamethasone sodium phosphate injection
Patients receive 0.8ml of dexamethazone by periodontal ligament injection 30 minutes before the inferior alveolar nerve block

Other:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.