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

Pulpitis - Irreversible Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116672
• Other study ID #: One Dose 2017
• Status: Completed
• Phase: N/A
• First received: March 28, 2017
• Last updated: April 14, 2017
• Start date: February 2, 2016
• Est. completion date: February 10, 2017

Study information

• Verified date: April 2017
• Source: Universidad Autonoma de Baja California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 10, 2017
• Est. primary completion date: February 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulpitis
• Pulpitis - Irreversible

Intervention

Drug:
• one dose ketorolac 10 mg
Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.
• One dose Diclofenac
Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.
• Placebo oral capsule
Administration of Placebo, 15 minutes before the clinical procedure.

Locations

Country	Name	City	State
Mexico	Jose Clemente	Tijuana	BC

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year after RCT
Secondary	Level of Post operative pain after administration of single dose before RCT	One dose of placebo	One year after root canal treatment