Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-15

Study Completion Date

2023-12-15

Brief Summary

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Removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients. Antibiotics, analgesics and/or anti-inflammatory drugs are prescribed for the treatment of complications encountered. Anti-inflammatory is the property of a substance or treatment that reduces inflammation or swelling. Anti-inflammatory drugs make up about half of analgesics, remedying pain by reducing inflammation as opposed to opioids, which affect the central nervous system to block pain signaling to the brain. Based on this information, in this study, it is aimed to evaluate the effects of deflazacort preoperatively on the postoperative pain, swelling and trismus.

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Detailed Description

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Conditions

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Impacted Third Molar Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Deflazacort

Deflazacort is a glucocorticoid used as an anti-inflammatory drug. We used deflazacort 30 mg tablet. Patient took a pill once preoperatively (1 hour ago) in third molar surgery.

Group Type EXPERIMENTAL

Deflazacort 30 MG Oral Tablet

Intervention Type DRUG

After the taken a deflazacort pill once preoperatively (one hour ago), local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml . The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation. Following the extraction, granulation tissues were removed, and bleeding was controlled. Finally, the mucoperiosteal flap was repositioned by 3.0 silk sutures.

Sugar pill

Placebo is an inert substance or treatment which is designed to have no therapeutic value. Patients took sugar pill for plasebo once one hour before operation.

Group Type PLACEBO_COMPARATOR

Sugar pill

Intervention Type DRUG

Sugar pill

Interventions

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Deflazacort 30 MG Oral Tablet

After the taken a deflazacort pill once preoperatively (one hour ago), local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml . The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation. Following the extraction, granulation tissues were removed, and bleeding was controlled. Finally, the mucoperiosteal flap was repositioned by 3.0 silk sutures.

Intervention Type DRUG

Sugar pill

Intervention Type DRUG

Other Intervention Names

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FLANTADIN 30 MG 10 TABLET

Eligibility Criteria

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Inclusion Criteria

* absence of any systemic disease,
* having bilateral impacted mandibular third molar teeth in a similar position
* absence of allergy to any of the drugs used in the study,
* absence of pregnancy/lactating state,
* no history of any medication use during at least 2 week before the operation.

Exclusion Criteria

* not regularly coming to the controls,
* not using their medicines regularly,
* using any additional medication that may affect the outcome of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No