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Evaluation of the Effect of Intra-ligamentary Injection of Diclofenac Potassium Versus Articaine on Anaesthetic Efficacy in Mandibular Molars With Symptomatic Irreversible Pulpitis.

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

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06500871
Enrollment
40
Registered
2024-07-15
Start date
2024-08-31
Completion date
2025-07-31
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teeth With Acute Irreverseble Pulpitis

Brief summary

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

1. Patients allergic to anesthetic solutions & other NSAIDs. 2. Pregnant or nursing females. 3. Patients having significant systemic disorder (ASA III or IV). 4. Gastrointestinal disorders. 5. If the initial diagnosis revealed pain in more than one tooth. 6. Hemostatic disorders or anti-coagulant therapy during the last month. 7. Consumption of opioid or non-opioid analgesics or NSAIDs during the last 12 hours before treatment. 8. 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. \-

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of local anesthesiaintraoperative ( access cavity preparation & instrumentation ) during root canal treatmentusing Heft parker Visual Analogue scale Binary where success is defined as no pain or faint/weak /mild pain\<55 mm). if \>55 defined as failure

Secondary

MeasureTime frameDescription
Intensity of intraoperative painintraoperative ( access cavity preparation & instrumentation ) during root canal treatmentusing Heft parker Visual analogue scale score ranges from on a 170-mm VAS line with the ends labeled no pain and unbearable pain. .no pain (\< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (\> 54 mm and \< 114 mm), Severe pain (≥ 114 mm).
Post-operative pain6, 12, 24 and 48 hours post-operativelyusing Heft parker Visual analogue scale on a 170-mm VAS line with the ends labeled no pain and unbearable pain. .no pain (\< 5 mm), mild pain (≥ 5 mm and ≤ 54 mm), Moderate pain (\> 54 mm and \< 114 mm), Severe pain (≥ 114 mm).
Number of needed analgesic tablets in case of intolerable painUp to 2 days post operativelyby counting

Contacts

Primary ContactMai Eldeeb, master
mai.eldeeb@dentistry.cu.edu.eg01093738532

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026