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

Primary Purpose

Anesthesia

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Brufen Retard

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibuprofen sustained release

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT05053009

First Posted

September 11, 2021

Last Updated

September 21, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT05053009

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 2021 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anesthesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Triple

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ibuprofen sustained release

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Brufen Retard

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficacy of buccal infiltration anaesthesia measured using Visual analogue scale

Description

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

Time Frame

During root canal treatment procedures

Secondary Outcome Measure Information:

Title

Intensity of intraoperative pain

Description

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

Time Frame

During root canal treatment procedures

Title

Postoperative pain

Description

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

Time Frame

up to 48 hours after endodontic treatment

Title

Number of needed analgesic tablets in case of intolerable pain

Description

The patient will record the number of analgesic tablets taken in case of intolerable pain

Time Frame

up to 48 hours after endodontic treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mariam Ah Hossam, B.D.S

Phone

01110913251

Ext

002

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

12. IPD Sharing Statement

Learn more about this trial

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

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