Effect of Ibuprofen Sustained Release on Intraoperative and Postoperative Pain in Mandibular Molars

NCT05053009 | Unknown DMC

• 1 other identifier: ENDO3-7-1
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is conducted to evaluate the effect of Ibuprofen sustained release premedication on the success of buccal infiltration anaesthesia, intaroperative pain and post operative pain in mandibular molars with symptomatic irreversible pulpitis and apical periodontitis

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale

  intensity of pain during root canal treatment procedures is recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain

  During root canal treatment procedures

Secondary Outcomes (3)

• Intensity of intraoperative pain

  During root canal treatment procedures

• Postoperative pain

  up to 48 hours after endodontic treatment

• Number of needed analgesic tablets in case of intolerable pain

  up to 48 hours after endodontic treatment

Study Arms (2)

Ibuprofen sustained release

EXPERIMENTAL

Single dose of 800 mg Brufen Retard oral premedication will be administered 1 hour before local anesthesia

Drug: Brufen Retard

Placebo

PLACEBO COMPARATOR

1 capsule of 500 mg of glucose oral premedication will be adminstered 1 hour before local anesthesia

Drug: Brufen Retard

Interventions

Brufen Retard DRUG

800 mg tablet of Brufen Retard will be adminstered orally one hour before local anesthesia

Ibuprofen sustained release; Placebo

Eligibility Criteria

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

You may qualify if:

• Systemically healthy patients (ASA I or II).
• Patients with Mandibular molar teeth diagnosed with:
• Pre-operative sharp pain marked on VAS scale by reading not less than 6.
• Vital exaggerated response of pulp tissue to cold pulp tester (ethyl chloride spray) and electric pulp tester.
• Normal periapical radiographic appearance or slight widening in lamina dura.
• Positive response and pain provoked by percussion.

You may not qualify if:

• Allergy to Ibuprofen
• Medically compromised patients having significant systemic disorders. (ASA III or IV).
• History of intolerance to NSAIDS.
• Patients with two or more adjacent teeth requiring endodontic treatment.
• Pregnant or nursing females.
• Teeth that have:
• Periodontal affection (with pocket depth greater than 5mm, associated with swelling or fistulous tract, or greater than grade I mobility)
• No possible restorability.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Mariam Ah Hossam, B.D.S

CONTACT

01110913251; mariam.ahmed.hosam@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at faculty of dentistry, Cairo University

Model Details: Parallel assignment

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: September 22, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09