Clinical trial NCT01706588: Injectable Diclofenac for the Prevention of Post-operative Dental Pain
Official title: Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: diclofenac, postsurgical pain, oral surgery
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2012-10-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.


Eligibility criteria: Inclusion Criteria:

1. Out-patients of either gender.
2. Patients aged ≥ 18 to ≤ 65 years old.
3. Subjects able and willing to give their written consent prior to inclusion in the study.
4. Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
5. Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
6. Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.

Exclusion Criteria:

General

1. Patients refusing to give written informed consent.
2. Patients not able to understand the purposes of the study or not willing to return for the control visits.
3. Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
4. Patients enrolled in any clinical trial in the previous 3 months.
5. Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
6. Pregnant or breast-feeding women.
7. Alcohol or drug abuse in the previous 12 months.
8. Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.

Primary outcomes:
measure: Area Under the Curve (AUC) of the Pain Scores.
timeFrame: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Secondary outcomes:
measure: Postsurgical Extra-oral Swelling
timeFrame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
measure: Trismus
timeFrame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
measure: Peak Pain Intensity
timeFrame: measured from end of surgery up to 12 hours postsurgery
measure: Time to First Use of Rescue Medication.
timeFrame: measured from end of surgery up to 1 week postsurgery
measure: Amount of Rescue Medication
timeFrame: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
measure: Rescue Medication Consumption
timeFrame: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
measure: Patient and Investigator Global Evaluation of the Effectiveness of Treatment
timeFrame: at 6 hour postsurgery and on Day 3
measure: Time to Onset of Pain
timeFrame: measured from end of surgery up to 12 hours postsurgery
measure: Wound Healing
timeFrame: at 6 hour postsurgery, and on day 3 and 1 week postsurgery
measure: Recurrent Bleeding
timeFrame: every hour up to 6 hour postsurgery
measure: Vital Signs
timeFrame: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
measure: Number of Patients With Adverse Events
timeFrame: from signature of the informed consent to 1 week postsurgery
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: The School of Dentistry University of Birmingham
Study officials:
affiliation: The School of Dentistry, University of Birmingham
name: Thomas Dietrich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorecki P, Rainsford KD, Taneja P, Bulsara Y, Pearson D, Saund D, Ahmed B, Dietrich T. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial. J Dent Res. 2018 Apr;97(4):381-387. doi: 10.1177/0022034517744207. Epub 2017 Dec 4.