Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

• Principal Investigator: Marcos P. Pinheiro, PhD; Federal University of Valleys of Jequitinhonha and Mucuri

More Information

• Responsible Party: Federal University of the Valleys of Jequitinhonha and Mucuri
• ClinicalTrials.gov Identifier: NCT02865746
• Other Study ID Numbers: ufvjm
• First Posted: August 12, 2016
• 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:

Emergencies; Pain, Postoperative; Disease Attributes; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations