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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05053009
• Other study ID #: ENDO3-7-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: October 2022

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: Mariam Ah Hossam, B.D.S
• Phone: 01110913251
• Email: mariam.ahmed.hosam[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intensity of intraoperative pain	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	Postoperative pain	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	up to 48 hours after endodontic treatment
Secondary	Number of needed analgesic tablets in case of intolerable pain	The patient will record the number of analgesic tablets taken in case of intolerable pain	up to 48 hours after endodontic treatment