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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Pulpitis - Irreversible

Treatments: Drug: Dexamethasone sodium phosphate injection; Other: 1,1,1,2 tetrafluoroethane; Other: intraoral soft tissue cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06330519

Ainshams University Dentistry

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

188 participants in 4 patient groups

intraligamentary dexamethazone

Experimental group

Treatment:

Drug: Dexamethasone sodium phosphate injection

Endo-ice cryotherapy

Active Comparator group

Treatment:

Other: 1,1,1,2 tetrafluoroethane

Intraoral soft tissue cryotherapy

Active Comparator group

Treatment:

Other: intraoral soft tissue cryotherapy

Inferior Alveolar nerve block only

No Intervention group