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

The Effect of Ibuprofen Sustained Release Oral Premedication on Intraoperative and Postoperative Pain After Single-visit Root Canal Treatment of Mandibular Molars With Symptomatic Irreversible Pulpitis and Apical Periodontitis

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05053009

Enrollment

Registered

2021-09-22

Start date

2021-11-30

Completion date

2022-10-31

Last updated

2021-09-22

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

Conditions

Anesthesia

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

Interventions

DRUGBrufen Retard

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Triple

Intervention model description

Parallel assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

1. Systemically healthy patients (ASA I or II). 2. 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.

Exclusion criteria

1. Allergy to Ibuprofen 2. Medically compromised patients having significant systemic disorders. (ASA III or IV). 3. History of intolerance to NSAIDS. 4. Patients with two or more adjacent teeth requiring endodontic treatment. 5. Pregnant or nursing females. 6. 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.

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale	During root canal treatment procedures	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

Secondary

Measure	Time frame	Description
Intensity of intraoperative pain	During root canal treatment procedures	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
Postoperative pain	up to 48 hours after endodontic treatment	Intensity of pain felt after endodontic treatment recorded by the patient using VAS where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
Number of needed analgesic tablets in case of intolerable pain	up to 48 hours after endodontic treatment	The patient will record the number of analgesic tablets taken in case of intolerable pain

Contacts

Primary ContactMariam Ah Hossam, B.D.S

mariam.ahmed.hosam@dentistry.cu.edu.eg01110913251

Outcome results

None listed

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