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Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

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ClinicalTrials.gov Identifier: NCT02865746
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Collaborator:
University of Campinas, Brazil
Information provided by (Responsible Party):
Federal University of the Valleys of Jequitinhonha and Mucuri

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE July 2004
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • Pain determined using the "Point Verbal Rating Scale - Modified VRS4" [ Time Frame: 4 hours after treatment ]
    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" [ Time Frame: 24 hours after treatment ]
    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" [ Time Frame: 48 hours after treatment ]
    During the post-surgical interval of 48 hours, the pain was determined using the "Point Verbal Rating Scale - Modified VRS4"
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • Analgesic consumption [ Time Frame: 4 hours after treatment ]
    Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
  • Analgesic consumption [ Time Frame: 24 hours after treatment ]
    Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
  • Analgesic consumption [ Time Frame: 48 hours after treatment ]
    Each patient was contacted by phone to answer how many analgesic pills have taken. None, 1, 2 or more.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Betamethasone to Control Postoperative Pain in Emergency Endodontic Care
Official Title  ICMJE Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • 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 Name: Group 1
  • 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 Name: Group 2
Study Arms  ICMJE
  • Active Comparator: Group betamethasone
    Active Comparator: betamethasone disodium phosphate at a concentration of 4 mg / ml - dosage of 0.05 mg / kg
    Intervention: Drug: Bethametasone
  • Placebo Comparator: Group placebo
    sterile saline solution (sodium chloride 0.9% - 1 ml ampoules) - dosage of 0.05 mg / kg
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2016)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date May 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 72 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02865746
Other Study ID Numbers  ICMJE ufvjm
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Federal University of the Valleys of Jequitinhonha and Mucuri
Study Sponsor  ICMJE Federal University of the Valleys of Jequitinhonha and Mucuri
Collaborators  ICMJE University of Campinas, Brazil
Investigators  ICMJE
Principal Investigator: Marcos P. Pinheiro, PhD Federal University of Valleys of Jequitinhonha and Mucuri
PRS Account Federal University of the Valleys of Jequitinhonha and Mucuri
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP