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Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Bethametasone
Placebo
Sponsored by
Federal University of the Valleys of Jequitinhonha and Mucuri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Steroids, Pain measurement

Eligibility Criteria

10 Years - 72 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal dos Vales do Jequitinhonha e Mucuri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group betamethasone

Group placebo

Arm Description

Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg

sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg

Outcomes

Primary Outcome Measures

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"
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"
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"

Secondary Outcome Measures

Analgesic consumption
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Analgesic consumption
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Analgesic consumption
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.

Full Information

First Posted
August 1, 2016
Last Updated
August 11, 2016
Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
Collaborators
University of Campinas, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02865746
Brief Title
Betamethasone to Control Postoperative Pain in Emergency Endodontic Care
Official Title
Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
Collaborators
University of Campinas, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Steroids, Pain measurement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group betamethasone
Arm Type
Active Comparator
Arm Description
Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg
Arm Title
Group placebo
Arm Type
Placebo Comparator
Arm Description
sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg
Intervention Type
Drug
Intervention Name(s)
Bethametasone
Other Intervention Name(s)
Group 1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Group 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
Description
During the post-surgical interval of 4 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Time Frame
4 hours after treatment
Title
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
Description
During the post-surgical interval of 24 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Time Frame
24 hours after treatment
Title
Pain determined using the "Point Verbal Rating Scale - Modified VRS4"
Description
During the post-surgical interval of 48 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Time Frame
48 hours after treatment
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Time Frame
4 hours after treatment
Title
Analgesic consumption
Description
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Time Frame
24 hours after treatment
Title
Analgesic consumption
Description
Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Time Frame
48 hours after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcos P. Pinheiro, PhD
Organizational Affiliation
Federal University of Valleys of Jequitinhonha and Mucuri
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal dos Vales do Jequitinhonha e Mucuri
City
Diamantina
State/Province
Minas Gerais
ZIP/Postal Code
39100000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

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