Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diclofenac Potassium.
- Who it may be relevant to
- Registry conditions: Teeth With Acute Irreverseble Pulpitis. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis:A Randomized Controlled Trial
Overview
This study aims to assess the effect the intraligamentary injection of Diclofenac Potassium versus Articaine 4% on the anaesthetic efficacy \& intensity of intraoperative \& postoperative pain during single visit root canal treatment in patients with symptomatic irreversible pulpitis in mandibular molar teeth
Interventions
- Drug Diclofenac Potassium
NSAID
Primary outcome measures
- Efficacy of local anesthesia [Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment]
Secondary outcome measures (3)
- Intensity of intraoperative pain [Time frame: intraoperative ( access cavity preparation & instrumentation ) during root canal treatment]
- Post-operative pain [Time frame: 6, 12, 24 and 48 hours post-operatively]
- Number of needed analgesic tablets in case of intolerable pain [Time frame: Up to 2 days post operatively]
Eligibility criteria
Inclusion criteria
- Systemically healthy patient (ASA I or II).
- Mandibular Posterior teeth with:
Preoperative sharp pain, Absence or slight widening in the periodontal ligament (PDL), Vital response of pulp tissue to cold pulp test.
- patients who agree to provide written consent and the patients able to understand the pain scale and attend for recall appointments
Exclusion criteria
- Patients allergic to anesthetic solutions \& other NSAIDs.
- Pregnant or nursing females.
- Patients having significant systemic disorder (ASA III or IV).
- Gastrointestinal disorders.
- If the initial diagnosis revealed pain in more than one tooth.
- Hemostatic disorders or anti-coagulant therapy during the last month.
- Consumption of opioid or non-opioid analgesics or NSAIDs during the last 12 hours before treatment.
- Teeth that have:
i. Periodontal involvement (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility).
ii. No possible restorability. iii.Signs of pulpal necrosis; associated sinus tract or swelling.
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06500871 · ENDO 9-1-2