NCT04365088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

4.9 years

First QC Date

April 24, 2020

Last Update Submit

August 20, 2023

Conditions

Impacted Third Molar Tooth

Keywords

deflazacortpainedematrismus

Outcome Measures

Primary Outcomes (11)

  • 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 1st day

  • 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 2nd day

  • 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 2nd day

  • 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 2nd day

  • 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 3d day

  • 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 4th day

  • 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 5th day

  • 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 6th day

  • 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 7th day

  • 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 7th day

  • 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 7th day

Study Arms (2)

Deflazacort

EXPERIMENTAL

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.

Drug: Deflazacort 30 MG Oral Tablet

Sugar pill

PLACEBO COMPARATOR

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.

Drug: Sugar pill

Interventions

Deflazacort 30 MG Oral TabletDRUG

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.

Also known as: FLANTADIN 30 MG 10 TABLET
Deflazacort
Sugar pillDRUG

Sugar pill

Sugar pill

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yuzuncu Yil University, Faculty of Dentistry

Van, Tuşba, 65080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainEdemaTrismus

Interventions

deflazacortTabletsSugars

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpasmNeuromuscular ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Oral and Maxillofacial Surgery Department

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

December 15, 2018

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)