NCT06787196

Brief Summary

This study aims to evaluate the effect of single-dose intravenous dexamethasone on postoperative pain and other complications in compacted tooth and cyst enucleation procedures performed under general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2024

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

December 27, 2024

Last Update Submit

May 12, 2025

Conditions

Tooth Extraction Status NosCysts DentalGeneral Anesthesia

Keywords

Dexamethasonepostoperative painmaxillofascial surgery

Outcome Measures

Primary Outcomes (1)

  • IV dexamethasone (DXM) changes postoperative complications

    Postoperative pain, swelling, and restricted mouth opening are identified as key postoperative concerns. The anti-inflammatory effects of dexamethasone (DXM) are utilized to address these complications.

    6 months

Study Arms (1)

Dexamethasone

EXPERIMENTAL

At the end of the procedure, patients received a single IV dose of Dexamethasone (0.1 mg/kg) before being extubated.

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Dexamethasone, single-dose, 8 mg IV administered intraoperatively

Also known as: Dekort
Dexamethasone

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-II
  • underwent split-mouth surgery

You may not qualify if:

  • Patients undergoing corticosteroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Funda Arun

Selçuklu, Konya, 42000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Radicular CystPain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Periodontal CystOdontogenic CystsJaw CystsBone CystsCystsNeoplasmsJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesPeriapical DiseasesPeriodontal DiseasesMouth DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Hasan Kucukkolbasi, prof.

    Selcuk University

    STUDY CHAIR

  • Emine Taskin, resid.

    Selcuk University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Dr.

Study Record Dates

First Submitted

December 27, 2024

First Posted

January 22, 2025

Study Start

January 1, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

May 13, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)