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Trial record 29 of 272 for:    Betamethasone

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

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Bethametasone Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Periapical Injection of Betamethasone to Control Postoperative Pain in Emergency Endodontic Care - A Randomized Double Blind Clinical Trial
Study Start Date : July 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : December 2005


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 Name: 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 Name: Group 2




Primary Outcome Measures :
  1. 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"

  2. 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"

  3. 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"


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   10 Years to 72 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865746


Locations
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Brazil
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, Brazil, 39100000
Sponsors and Collaborators
Federal University of the Valleys of Jequitinhonha and Mucuri
University of Campinas, Brazil
Investigators
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Principal Investigator: Marcos P. Pinheiro, PhD Federal University of Valleys of Jequitinhonha and Mucuri

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Responsible Party: Federal University of the Valleys of Jequitinhonha and Mucuri
ClinicalTrials.gov Identifier: NCT02865746     History of Changes
Other Study ID Numbers: ufvjm
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Federal University of the Valleys of Jequitinhonha and Mucuri:
Steroids
Pain measurement
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Emergencies
Pain, Postoperative
Disease Attributes
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents