92/5000 Preoperative Efficacy of Traumeel Versus Dexameth... | NCT03567369

Studies
92/5000 Preoperative Efficacy of Traumeel Versus Dexamethasone in the Control of Pain, Swelling and Trismus

NCT03567369

Sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri

Status

Unknown status

Last Update Posted

Jun 25, 2018Actual

Enrollment

17Estimated

Phase

Not Applicable

Conditions

Molar, Third
Surgery

Interventions

Dexamethasone
Traumeel S

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2, 2018Actual

Primary Completion Date

Jul 31, 2018Estimated

Completion Date

Oct 31, 2018Estimated

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

Jun 12, 2018

First Posted Date

Jun 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2018

Last Update Posted Date

Jun 25, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcos Luciano Pimenta Pinheiro, Principal Investigator, Federal University of the Valleys of Jequitinhonha and MucuriPrincipal Investigator

Lead Sponsor

Federal University of the Valleys of Jequitinhonha and MucuriOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dexamethasone	Experimental	Dexamethasone 4,0 mg / mL	Drug: Dexamethasone
Traumeel S	Experimental	Traumeel 2,2 mg / mL	Drug: Traumeel S

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Dexamethasone 4,0 mg/mL	Dexamethasone	Dexamethasone Acetate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Federal dos Vales do Jequitinhonha e Mucuri		Diamantina	Minas Gerais	39100000	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone
C018038	dexamethasone acetate
D002123	Calcium Dobesilate
C433370	Traumeel S

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided