Effect of Preoperative Oral Ibuprofen on Anesthetic Efficacy of Inferior Alveolar Nerve Block With Supplemental Buccal and Lingual Infiltrations Using Articaine in Mandibular Molar Teeth With Irreversible Pulpitis

NCT05927922 | Completed Phase 1

• 1 other identifier: ENDO 3/7/1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of preoperative oral Ibuprofen on anesthetic efficacy of inferior alveolar nerve block with supplemental buccal and lingual infiltrations using articaine in mandibular molar teeth with irreversible pulpitis.

Conditions

Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Success rate of local anesthesia

  Success rate of local anesthesia through measuring pain during root canal treatment using HP VAS. It is a line numbered from 0-170mm, where pain levels are categorized as follows: * "0" = no pain * 1-54mm = faint, weak or mild pain * 55-114mm = moderate pain * 114-170mm = strong, intense or severe pain, "170mm" being the most intense pain conceivable. where success is defined as no or mild pain (0-54mm) throughout the procedure

  During access cavity preparation and cleaning and shaping procedures of root canal treatment.

Secondary Outcomes (1)

• Degree of post-operative pain

  6, 12, 24 and 48 hours post-operatively.

Study Arms (2)

Premedication with 600 mg of Oral Ibuprofen

EXPERIMENTAL

Premedication with 600 mg of Oral Ibuprofen (Abbott, Egypt) will be given 1 hour before IANB.

Drug: Oral Ibuprofen (Abbott, Egypt)

Placebo will be given 1 hour before inferior alveolar nerve block

PLACEBO COMPARATOR

Drug: Oral Ibuprofen (Abbott, Egypt)

Interventions

Oral Ibuprofen (Abbott, Egypt) DRUG

ibuprofen is analegisic drug used to relieve pain

Placebo will be given 1 hour before inferior alveolar nerve block; Premedication with 600 mg of Oral Ibuprofen

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females with age between 18-50 years.
• Systemically healthy patients (ASA I or II).
• patient's signs and symptoms give diagnosis of symptomatic irreversible pulpitis in mandibular molar teeth including: i. Presence of sharp pain upon thermal stimulus, lingering pain (often 30 seconds or longer after stimulus removal), spontaneity (unprovoked pain) and referred pain (According to American Association of Endodontics, 2013). According to Azim et al (2022), a clinical diagnosis for symptomatic irreversible pulpitis based on subjective (lingering pain to thermal changes for extended period).
• ii. Pre-operative sharp pain marked on VAS scale by reading not less than 6. iii. exaggerated response with continuous lingering pain to cold pulp tester using ethyl chloride spray (Walter Ritter Gmbh +Co.-pharmaceutical - Germany. The Egyptian pharmaceutical trading company) and electric pulp tester (Denjoy dental CO., LTD.Changsha.P.R China).
• iv. Normal periapical radiographic appearance or slight widening of the periodontal ligament space.
• v.Presence of objective findings such as caries or fracture, deep restorations. vi. No pain on percussion.

You may not qualify if:

• Allergy to articaine or Ibuprofen
• History of intolerance to NSAIDs.
• Patients who have taken analgesics or anti-inflammatory drugs 12 hours before treatment.
• Patients with two or more adjacent teeth requiring endodontic treatment.
• Pregnant or nursing females.
• Teeth that have periodontal affection (with a pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility)
• Non-restorable teeth.
• Teeth fracture and resorption.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of dentistry Cairo university

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study will be a double-blinded randomized controlled trial where the patient \& operator will not be aware of the intervention used. -the treatment groups will be anonymous to the assessing statistician at the end of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohamed Ahmed Abdelhameed

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: June 20, 2023
• Primary Completion: June 20, 2024
• Study Completion: June 25, 2024
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)