Injectable Diclofenac for the Prevention of Post-operative Dental Pain
DP4
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
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 pain
Started Jan 2013
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 15, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
August 28, 2014
CompletedSeptember 5, 2014
August 1, 2014
4 months
October 1, 2012
August 13, 2014
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Curve (AUC) of the Pain Scores.
Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Secondary Outcomes (12)
Postsurgical Extra-oral Swelling
measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Trismus
measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Peak Pain Intensity
measured from end of surgery up to 12 hours postsurgery
Time to First Use of Rescue Medication.
measured from end of surgery up to 1 week postsurgery
Amount of Rescue Medication
consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
- +7 more secondary outcomes
Study Arms (5)
Diclofenac sodium 5 mg/mL
EXPERIMENTALDiclofenac sodium 12.5 mg/mL
EXPERIMENTALDiclofenac sodium 25 mg/mL
EXPERIMENTALDiclofenac sodium 50 mg/mL
EXPERIMENTALPlacebo 1 mL
PLACEBO COMPARATORInterventions
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Eligibility Criteria
You may qualify if:
- Out-patients of either gender.
- Patients aged ≥ 18 to ≤ 65 years old.
- 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.
- Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.
You may not qualify if:
- General
- Patients refusing to give written informed consent.
- Patients not able to understand the purposes of the study or not willing to return for the control visits.
- Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
- Patients enrolled in any clinical trial in the previous 3 months.
- 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.
- Pregnant or breast-feeding women.
- Alcohol or drug abuse in the previous 12 months.
- Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The School of Dentistry University of Birmingham
Birmingham, B4 6NN, United Kingdom
Related Publications (1)
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.
PMID: 29202646DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Thomas Dietrich
- Organization
- The School of Dentistry, University of Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Dietrich, MD
The School of Dentistry, University of Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 15, 2012
Study Start
January 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
September 5, 2014
Results First Posted
August 28, 2014
Record last verified: 2014-08