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

Primary Purpose

Impacted Third Molar Tooth

Status
Active
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Deflazacort 30 MG Oral Tablet
Sugar pill
Sponsored by
Yuzuncu Yıl University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Impacted Third Molar Tooth focused on measuring deflazacort, pain, edema, trismus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Van Yuzuncu Yil University, Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Deflazacort

Sugar pill

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative Pain
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Postoperative Pain
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Postoperative Edema
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.
Postoperative Trismus
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Postoperative Pain
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Postoperative Pain
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Postoperative Pain
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Postoperative Pain
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Postoperative Pain
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Postoperative Edema
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.
Postoperative Trismus
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.

Secondary Outcome Measures

Full Information

First Posted
April 24, 2020
Last Updated
August 20, 2023
Sponsor
Yuzuncu Yıl University
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1. Study Identification

Unique Protocol Identification Number
NCT04365088
Brief Title
Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus
Official Title
Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
deflazacort, pain, edema, trismus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deflazacort
Arm Type
Experimental
Arm Description
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.
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Deflazacort 30 MG Oral Tablet
Other Intervention Name(s)
FLANTADIN 30 MG 10 TABLET
Intervention Description
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
Intervention Name(s)
Sugar pill
Intervention Description
Sugar pill
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 1st day
Title
Postoperative Pain
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 2nd day
Title
Postoperative Edema
Description
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.
Time Frame
Postoperative 2nd day
Title
Postoperative Trismus
Description
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time Frame
Postoperative 2nd day
Title
Postoperative Pain
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 3d day
Title
Postoperative Pain
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 4th day
Title
Postoperative Pain
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 5th day
Title
Postoperative Pain
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 6th day
Title
Postoperative Pain
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 7th day
Title
Postoperative Edema
Description
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.
Time Frame
Postoperative 7th day
Title
Postoperative Trismus
Description
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time Frame
Postoperative 7th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
State/Province
Tuşba
ZIP/Postal Code
65080
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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