Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial

The objective of this randomized double-blind study was to evaluate the effect of betamethasone in the control of postoperative pain in patients undergoing endodontic treatment.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Bethametasone; Drug: Placebo

Detailed Description

To prevent post endodontic treatment pain, systemic administration of corticosteroids may have their effect maximized if the infiltration is performed in the oral mucosa, near the periapex of the tooth, which concentrates the inflammatory process. The administration of corticosteroids at this moment, taking advantage of the anesthetic effect still present, ensures continuous comfort during the postoperative period.

The objective of this randomized double-blind clinical trial was to evaluate the effect of the systemic administration of betamethasone - through infiltration in the oral mucosa - to control pain and edemas in patients undergoing emergency endodontic treatment.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Diamantina, Minas Gerais, Brazil, 39100000
      • Universidade Federal dos Vales do Jequitinhonha e Mucuri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 72 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals had to have a tooth with pain of endodontic origin justifying emergency care;
• Individuals diagnosed with irreversible pulpitis or necrosis associated to pericementitis.

Exclusion Criteria:

Individuals who presented:

• Pregnancy or lactation;
• Use of corticosteroids;
• History of hypersensitivity to the drugs used in this study;
• Pain associated with abscesses of endodontic origin;
• Individuals with tuberculosis;
• Individuals with systemic fungal infections;
• Individuals with simple ocular herpes;
• Individuals with glaucoma;
• Individuals with acute psychosis.
• Individuals with psychotic tendencies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group betamethasone; Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg	Drug: Bethametasone; The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.; Other Names: Group 1
Placebo Comparator: Group placebo; sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg	Drug: Placebo; The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.; Other Names: Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"	During the post-surgical interval of 4 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"	4 hours after treatment
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"	During the post-surgical interval of 24 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"	24 hours after treatment
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"	During the post-surgical interval of 48 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"	48 hours after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic consumption	Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.	4 hours after treatment
Analgesic consumption	Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.	24 hours after treatment
Analgesic consumption	Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.	48 hours after treatment

Collaborators and Investigators

• Sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
• Collaborators: University of Campinas, Brazil
• Investigators: Principal Investigator: Marcos P. Pinheiro, PhD, Federal University of Valleys of Jequitinhonha and Mucuri

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Estimate): August 12, 2016
• Last Update Submitted That Met QC Criteria: August 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Pain measurement; Steroids
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease Attributes; Pain, Postoperative; Emergencies
• Other Study ID Numbers: ufvjm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED