The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo (PreOp)
Primary Purpose
Pulpitis - Irreversible
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
one dose ketorolac 10 mg
One dose Diclofenac
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis - Irreversible focused on measuring pain, Diclofenac, NSAID, Ketorolac
Eligibility Criteria
Inclusion Criteria:
Patient selection was based on the following criteria:
- The aims and requirements of the study were freely accepted;
- Treatment was limited to patients in good health;
- Patients with symptomatic or asymptomatic teeth with vital pulps and apical periodontitis;
- A positive response to hot and cold pulp sensitivity tests;
- Presence of sufficient coronal tooth structure for rubber dam isolation;
- No prior endodontic treatment on the involved tooth and
- No analgesics or antibiotics were used five days before the clinical procedures began.
Exclusion Criteria:
Exclusion criteria included the following:
- Patients who did not meet inclusion requirements;
- Patients who did not provide authorization for participation;
- Patients who were younger than 16 years old;
- Patients who were pregnant;
- Patients who were diabetic;
- Patients with a positive history of antibiotic use within the past month;
- Patients whose tooth had been previously accessed or endodontically treated;
- Teeth with root resorption, and
- Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm, or the presence of a periapical radiolucency more than 2 cm diameter also were excluded of the study.
Sites / Locations
- Jose Clemente
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ketorolac 10 mg
Diclofenac
Placebo oral capsule
Arm Description
Administration of one dose Ketorolac 10 mg 15 minutes before treatment
Administration of one dose Diclofenac 15 minutes before treatment
Administration of Placebo capsule 15 minutes before treatment
Outcomes
Primary Outcome Measures
Level of post operative pain with administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis
One dose administration before the RCT done
Secondary Outcome Measures
Level of Post operative pain after administration of single dose before RCT
One dose of placebo
Full Information
NCT ID
NCT03116672
First Posted
March 28, 2017
Last Updated
April 14, 2017
Sponsor
Universidad Autonoma de Baja California
1. Study Identification
Unique Protocol Identification Number
NCT03116672
Brief Title
The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo
Acronym
PreOp
Official Title
The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo on Postoperative Pain in Teeth With Irreversible Pulpitis and Apical Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
February 10, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Baja California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim. To compare the outcome of preoperative administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis.
Detailed Description
The institutional review board of the Faculty od Odontology Tijuana México approved the study protocol and all the participants were treated in accordance with the Helsinki Declaration (www.cirp.org/library/ethics/helsinki). The study started in February 2016 and ended in February 2017. The main inclusion criteria were: a) A diagnosis of pulpitis confirmed by positive response to hot and cold tests and b) Clinical and radiographic evidence of symptomatic apical periodontitis. It was determined based on the clinical symptoms severe preoperative pain (VAS > 60) and severe percussion pain (VAS > 60). Confirmed by positive response to hot and cold tests. Thermal pulp testing was performed by the author, and radiographic interpretation was verified by one certified oral surgeon.
Patient selection.
Fifty-four of sixty-five patients (29 women and 25 men), 18 to 60 years of age with 54 eligible teeth consented to participate in the study. The study design is shown in Figure 1. The patients were randomly divided into three groups using a web program. The patient number and group number were recorded. Informed consent was obtained from each patient and the possible discomforts and risks were fully explained.
A total of 54 patients were divided into three groups (n = 18) according to the type of preoperative drug administrated, as follows: Group A: ketorolac 10mg (Siegfried Rhein S.A. de C.V, Mexico,DF), Group B: Diclofenac Na 50mg (Voltaren, Novartis Mexico), and Group C: A placebo (capsule filled with sugar).
A registered pharmacist compounded identical-appearing capsules of the ketorolac, Diclofenac Na and the placebo (opaque yellow size ''0'' capsules). All medications were placed in identical bottles so that they were indistinguishable to the investigator.
The administration of drugs and root canal treatment were performed by two different researchers. One assistant knew the allocation and the drug type in the capsules, but the operator and the patient did not know which drug type was administered.
Patient selection was based on the following criteria: 1) The aims and requirements of the study were freely accepted; 2) Treatment was limited to patients in good health; 3) Patients with symptomatic or asymptomatic teeth with vital pulps and apical periodontitis; 4) A positive response to hot and cold pulp sensitivity tests; 5) Presence of sufficient coronal tooth structure for rubber dam isolation; 6) No prior endodontic treatment on the involved tooth and 7) No analgesics or antibiotics were used five days before the clinical procedures began.
Exclusion criteria included the following: 1) Patients who did not meet inclusion requirements; 2) Patients who did not provide authorization for participation; 3) Patients who were younger than 16 years old; 4) Patients who were pregnant; 5) Patients who were diabetic; 6) Patients with a positive history of antibiotic use within the past month; 7) Patients whose tooth had been previously accessed or endodontically treated; 8) Teeth with root resorption, and 9) Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm, or the presence of a periapical radiolucency more than 2 cm diameter also were excluded of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis - Irreversible
Keywords
pain, Diclofenac, NSAID, Ketorolac
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patient selection.
Fifty-four of sixty-five patients (29 women and 25 men), 18 to 60 years of age with 54 eligible teeth consented to participate in the study. The patients were randomly divided into three groups using a web program. The patient number and group number were recorded. Informed consent was obtained from each patient and the possible discomforts and risks were fully explained.
A total of 54 patients were divided into three groups (n = 18) according to the type of preoperative drug administrated.
Masking
Participant
Masking Description
Patient selection.
Fifty-four of sixty-five patients (29 women and 25 men), 18 to 60 years of age with 54 eligible teeth consented to participate in the study. The patients were randomly divided into three groups using a web program. The patient number and group number were recorded. Informed consent was obtained from each patient and the possible discomforts and risks were fully explained.
A total of 54 patients were divided into three groups (n = 18) according to the type of preoperative drug administrated, as follows: Group A: Administration of ketorolac 10mg, Group B: Administration of Diclofenac Na 50mg, and Group C: A placebo (capsule filled with sugar).
After 15 minutes each participant received the treatment.
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ketorolac 10 mg
Arm Type
Experimental
Arm Description
Administration of one dose Ketorolac 10 mg 15 minutes before treatment
Arm Title
Diclofenac
Arm Type
Experimental
Arm Description
Administration of one dose Diclofenac 15 minutes before treatment
Arm Title
Placebo oral capsule
Arm Type
Experimental
Arm Description
Administration of Placebo capsule 15 minutes before treatment
Intervention Type
Drug
Intervention Name(s)
one dose ketorolac 10 mg
Other Intervention Name(s)
Dolac
Intervention Description
Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.
Intervention Type
Drug
Intervention Name(s)
One dose Diclofenac
Other Intervention Name(s)
Diclofenaco
Intervention Description
Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo OS
Intervention Description
Administration of Placebo, 15 minutes before the clinical procedure.
Primary Outcome Measure Information:
Title
Level of post operative pain with administration of single-dose ketorolac, non-steroidal anti-inflammatory drug and placebo on postoperative pain in teeth with irreversible pulpitis and apical periodontitis
Description
One dose administration before the RCT done
Time Frame
1 year after RCT
Secondary Outcome Measure Information:
Title
Level of Post operative pain after administration of single dose before RCT
Description
One dose of placebo
Time Frame
One year after root canal treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient selection was based on the following criteria:
The aims and requirements of the study were freely accepted;
Treatment was limited to patients in good health;
Patients with symptomatic or asymptomatic teeth with vital pulps and apical periodontitis;
A positive response to hot and cold pulp sensitivity tests;
Presence of sufficient coronal tooth structure for rubber dam isolation;
No prior endodontic treatment on the involved tooth and
No analgesics or antibiotics were used five days before the clinical procedures began.
Exclusion Criteria:
Exclusion criteria included the following:
Patients who did not meet inclusion requirements;
Patients who did not provide authorization for participation;
Patients who were younger than 16 years old;
Patients who were pregnant;
Patients who were diabetic;
Patients with a positive history of antibiotic use within the past month;
Patients whose tooth had been previously accessed or endodontically treated;
Teeth with root resorption, and
Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm, or the presence of a periapical radiolucency more than 2 cm diameter also were excluded of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel O Osuna, DDS
Organizational Affiliation
SECRETARIA DE SALUD DE BC
Official's Role
Study Director
Facility Information:
Facility Name
Jose Clemente
City
Tijuana
State/Province
BC
ZIP/Postal Code
22000
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Invitation to participate. Offer to the public All the clinical procedure and risks were explained to each participant.
Citations:
PubMed Identifier
22892729
Citation
Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
http://www.uabc.mx
Available IPD/Information Identifier
UABC
Available IPD/Information Comments
Clinical trial that evaluate drug and placebo
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://www.uabc.mx
Available IPD/Information Identifier
protocol guide
Available IPD/Information Comments
Clinical Guide
Learn more about this trial
The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo
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