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
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Basic Information
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COMPLETED
PHASE4
188 participants
INTERVENTIONAL
2023-02-01
2024-03-30
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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intraligamentary dexamethazone
Dexamethasone sodium phosphate injection
Patients receive 0.8ml of dexamethazone by periodontal ligament injection 30 minutes before the inferior alveolar nerve block
Endo-ice cryotherapy
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
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
Inferior Alveolar nerve block only
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
40 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Other Identifiers
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Ainshams University Dentistry
Identifier Type: -
Identifier Source: org_study_id
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