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The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo (PreOp)

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ClinicalTrials.gov Identifier: NCT03116672
Recruitment Status : Completed
First Posted : April 17, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Jorge Paredes Vieyra, Universidad Autonoma de Baja California

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.

Condition or disease Intervention/treatment Phase
Pulpitis - Irreversible Drug: one dose ketorolac 10 mg Drug: One dose Diclofenac Drug: Placebo oral capsule Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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.

Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : February 6, 2017
Actual Study Completion Date : February 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ketorolac 10 mg
Administration of one dose Ketorolac 10 mg 15 minutes before treatment
Drug: one dose ketorolac 10 mg
Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.
Other Name: Dolac

Experimental: Diclofenac
Administration of one dose Diclofenac 15 minutes before treatment
Drug: One dose Diclofenac
Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.
Other Name: Diclofenaco

Experimental: Placebo oral capsule
Administration of Placebo capsule 15 minutes before treatment
Drug: Placebo oral capsule
Administration of Placebo, 15 minutes before the clinical procedure.
Other Name: Placebo OS




Primary Outcome Measures :
  1. 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 [ Time Frame: 1 year after RCT ]
    One dose administration before the RCT done


Secondary Outcome Measures :
  1. Level of Post operative pain after administration of single dose before RCT [ Time Frame: One year after root canal treatment ]
    One dose of placebo



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116672


Locations
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Mexico
Jose Clemente
Tijuana, BC, Mexico, 22000
Sponsors and Collaborators
Universidad Autonoma de Baja California
Investigators
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Study Director: Miguel O Osuna, DDS SECRETARIA DE SALUD DE BC

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: UABC
Clinical trial that evaluate drug and placebo
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: protocol guide
Clinical Guide

Publications of Results:
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Responsible Party: Jorge Paredes Vieyra, Principal Investigator. PhD, Universidad Autonoma de Baja California
ClinicalTrials.gov Identifier: NCT03116672     History of Changes
Other Study ID Numbers: One Dose 2017
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Invitation to participate. Offer to the public All the clinical procedure and risks were explained to each participant.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jorge Paredes Vieyra, Universidad Autonoma de Baja California:
pain
Diclofenac
NSAID
Ketorolac

Additional relevant MeSH terms:
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Pulpitis
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Diclofenac
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action