Betamethasone to Control Postoperative Pain in Emergency Endodontic Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group betamethasone

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

Group Type ACTIVE_COMPARATOR

Bethametasone

Intervention Type 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.

Group placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Group 1 Group 2

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

72 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes