NCT05951504

The Prospective Evaluation of Peri-Operative Glucocorticoid Use in the Management of Cervicofacial Infections of Odontogenic Origin

Completed Phase 2, PHASE3 Last updated 21 July 2023

What this trial tests

Phase 2, PHASE3 trial testing Methylprednisolone in Odontogenic Infection of Jaw (Disorder) in 29 participants. Completed in 1 July 2023.

Timeline

22 June 2022

Primary endpoint
30 March 2023

1 July 2023

Quick facts

Lead sponsor	University of Manitoba
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	22 June 2022
Primary completion	30 March 2023
Estimated completion	1 July 2023
Sites	1 location across Canada

Drugs / interventions tested

• Methylprednisolone (methylprednisolone) — full drug profile →

Conditions studied

• Odontogenic Infection of Jaw (Disorder) — all drugs for Odontogenic Infection of Jaw (Disorder) →

Sponsor

University of Manitoba

Who can join

Eligibility, any sex, with Odontogenic Infection of Jaw (Disorder). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a clinical trial. In Manitoba, the treatment of cervicofacial infections of odontogenic origin which require inpatient medical and surgical management by Oral and Maxillofacial Surgeons are treated in a reproducible and stepwise manner. After a standardized pre-operative diagnostic workup (including appropriate imaging, bloodwork, and pre-operative history and physical), these patients are taken to the operating room for appropriate surgical intervention (extraction of necessary teeth and incision/drainage of the associated abscess). These patients are then treated with a combination of antibiotics, steroids, and adjunctive medications as needed for supportive care until ready for discharge.

Intravenous corticosteroids are frequently administered following dentoalveolar and maxillofacial surgery procedures to decrease post-operative edema, improve patient comfort, and thus hasten recovery time. Within the context of primary and deep space odontogenic infections, one of the major sources of morbidity is the mass effect produced by edema causing airway obstruction. Additionally, manipulation of the soft tissues during the surgical procedure(s) (incision and drainage, extraction of teeth, etc.) may result in increased swelling around the airway. Inflammation and spasm of the muscles of mastication is another sequelae of infection, which can result in severe trismus. The literature supports the use of intravenous corticosteroids as an adjunctive treatment in the management of primary and deep space neck infections, and thus corticosteroid use is within the standard of care. However, the glucocorticoid dosing regimen is currently determined by the clinical judgment of the attending surgeon. One commonly used regimen for steroid dosing is prescribing Solumedrol 125mg IV X1 dose at the time of surgery. Another commonly used regimen for steroid dosing is prescribing Solumedrol 125mg IV X1 dose at the time of surgery, followed by 3 consecutive doses of Solumedrol 125mg IV every 6 hours post-operatively.

The goal of this study is to guide future decisions related to the treatment of patients with cervicofacial infections of odontogenic origin in Manitoba. This study is intended to follow the post-operative inpatient course of 30 patients with various cervicofacial infections of odontogenic origin. All will be treated via a standardized surgical protocol (incision/drainage and extraction of necessary teeth), antibiotics, and steroids. 15 patients will be randomly assigned to receive 1 dose of Solumedrol 125mg IV at the time of surgery but no doses following surgery. The remaining 15 patients will receive 1 dose of Solumedrol 125mg IV at the time of surgery plus 3 consecutive doses of Solumedrol 125mg IV every 6 hours post-operatively. In summary, the only impact of study involvement will be the determination of the intravenous glucocorticoid dosing schedule, as all patients will continue to receive the current standard of care (including surgical management, antibiotics, and intravenous corticosteroids).

To ensure the preservation of the highest level of patient care, in the rare instance where an attending surgeon decides peri-operatively that the pre-determined steroid dosing regimen will result in unsatisfactory treatment, the randomized patient assignment will be abandoned, and alternative treatment regimens will be used under the guidance of the attending Oral and Maxillofacial Surgeon.

Treatment will be undertaken at the Health Sciences Centre adult operating room and inpatient wards, the primary operating site for the University of Manitoba's attending on-call Oral and Maxillofacial Surgeons. The patient's post-operative course in hospital will be completed within the inpatient wards at the Health Sciences Centre, until the patients are deemed appropriate for discharge.

Specific patient outcomes will be evaluated at the time of hospital admission, daily while admitted to hospital, and at the time of hospital discharge. Outcomes evaluated will include:

* C reactive protein (CRP) levels (acute phase reactant which is a hematologic biomarker of inflammation)
* White blood cell (WBC) levels (hematologic biomarker of infection)
* Length of hospital admission (days)
* Trismus (in mm)
* Daily clinical examination findings (during morning inpatient rounds while admitted)

This study poses no additional risks to the patients involved, as these patients would be receiving intravenous glucocorticoids whether they were enrolled in the study or not. There are standard risks of complications involved with both the surgical and pharmaceutical treatment of cervicofacial infections of odontogenic origin, and these risks are discussed with patients pre-operatively and prior to hospital admission to obtain informed written consent.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.