NCT03567369

Brief Summary

To compare the efficacy of intramuscular injection of two anti-inflammatory drugs, Traumeel and Dexamethasone, used in the control of postoperative complications pain, edema and trismus after third molar extraction mandibular

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
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

June 25, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

May 14, 2018

Last Update Submit

June 12, 2018

Conditions

Molar, ThirdSurgery

Keywords

Third molarSurgerySwelling

Outcome Measures

Primary Outcomes (1)

  • Postoperative sequelae following thir molar extraction

    During the postoperative intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face and trismus by maximum mouth opening. The postoperative pain was self-recorded by the patient using visual analogue scale in 72 hours with an interval of eight hours

    up to seven days postoperative

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Dexamethasone 4,0 mg / mL

Drug: Dexamethasone

Traumeel S

EXPERIMENTAL

Traumeel 2,2 mg / mL

Drug: Traumeel S

Interventions

DexamethasoneDRUG

Dexamethasone 4,0 mg/mL

Also known as: Dexamethasone Acetate, Decadron®
Dexamethasone
Traumeel SDRUG

Traummel S 2,2 mg/mL

Traumeel S

Eligibility Criteria

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

You may qualify if:

  • Patients with indication of asymptomatic bilateral extractions of lower third molars;
  • Aged 18 years or older;
  • Have a good health and no disease.

You may not qualify if:

  • Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

Location

MeSH Terms

Interventions

Dexamethasonedexamethasone acetateCalcium DobesilateTraumeel S

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 14, 2018

First Posted

June 25, 2018

Study Start

April 2, 2018

Primary Completion

July 31, 2018

Study Completion

October 31, 2018

Last Updated

June 25, 2018

Record last verified: 2018-05

Locations

BR(1)