Pulpitis - IrreversiblePreOpNCT03116672
The Outcome of Preoperative Administration of Single-dose Ketorolac, Non-steroidal Anti-inflammatory Drug and Placebo
A study testing one dose ketorolac 10 mg and One dose Diclofenac in people with Pulpitis - Irreversible, run by Universidad Autonoma de Baja California at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis - Irreversible
- What is being tested?
- one dose ketorolac 10 mg and One dose Diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteMexico
- Study dates
- 2 Feb 2016to 10 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Pulpitis - Irreversible
- Being tested
- one dose ketorolac 10 mg, One dose Diclofenac, Placebo oral capsule
- Keywords
- pain, Diclofenac, NSAID, Ketorolac
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one dose ketorolac 10 mgDrug
Also called Dolac
Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.
One dose DiclofenacDrug
Also called Diclofenaco
Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.
Placebo oral capsuleDrug
Also called Placebo OS
Administration of Placebo, 15 minutes before the clinical procedure.
| Study group | Role | What they receive |
|---|---|---|
| ketorolac 10 mg | Experimental | Administration of one dose Ketorolac 10 mg 15 minutes before treatment Receives: Drug: one dose ketorolac 10 mg |
| Diclofenac | Experimental | Administration of one dose Diclofenac 15 minutes before treatment Receives: Drug: One dose Diclofenac |
| Placebo oral capsule | Experimental | Administration of Placebo capsule 15 minutes before treatment Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year after RCT
Secondary outcomes (1)
Level of Post operative pain after administration of single dose before RCT
One dose of placebo
Measured: One year after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start2 Feb 2016
- Primary completion6 Feb 2017
- Study completion10 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulpitis - IrreversibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Paredes Vieyra, Universidad Autonoma de Baja California
- Investigators
- Miguel O Osuna, DDS, Study director, SECRETARIA DE SALUD DE BC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116672
- Sponsor's protocol ID
- One Dose 2017
- Acronym
- PreOp
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Invitation to participate. Offer to the public All the clinical procedure and risks were explained to each participant.
Publications
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.
PubMed 22892729
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03116672
- Acronym / sponsor ID
- PreOp / One Dose 2017
- Conditions
- Pulpitis - Irreversible
- Keywords
- pain, Diclofenac, NSAID, Ketorolac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 10 Feb 2017 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| ketorolac 10 mg | Experimental | Drug: one dose ketorolac 10 mgAdministration of one dose Ketorolac 10 mg 15 minutes before treatment |
| Diclofenac | Experimental | Drug: One dose DiclofenacAdministration of one dose Diclofenac 15 minutes before treatment |
| Placebo oral capsule | Experimental | Drug: Placebo oral capsuleAdministration of Placebo capsule 15 minutes before treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one dose ketorolac 10 mgAlso: DolacAdministration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure. | Drug | ketorolac 10 mg |
| One dose DiclofenacAlso: DiclofenacoAdministration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure. | Drug | Diclofenac |
| Placebo oral capsuleAlso: Placebo OSAdministration of Placebo, 15 minutes before the clinical procedure. | Drug | Placebo oral capsule |
Primary outcome
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
1 secondary outcome
Level of Post operative pain after administration of single dose before RCT
Time frame: One year after root canal treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Results publication: PubMed 22892729Paredes-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.
- Individual participant dataSharing planned: Yes. Invitation to participate. Offer to the public All the clinical procedure and risks were explained to each participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel O Osuna, DDS study director
SECRETARIA DE SALUD DE BC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one dose ketorolac 10 mg and One dose Diclofenac in people with Pulpitis - Irreversible, run by Universidad Autonoma de Baja California at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03116672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.