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Completed

NCT Number: NCT02865746

Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bethametasone

Drug

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

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Other

Collaborators

  • University of Campinas, Brazil

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Aug 12, 2016
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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