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TO EVALUATE THE EFFECT THAT PRODUCE THE MIX OF DEXAMETASONE+BUPIVACAINE+ARTICAINE+EPINEFRINE IN THE COMFORT OF POSTQUIRURGICAL PAIN AFTER THE THIRD MOLAR REMOVING.

CLINICAL TRIAL TO EVALUATE THE EFFICACY AND THE SECURITY OF DEXAMETASONE+BUPIBACAINE+ARTICAINE+EPINEFRINE “VERSUS” ARTICAINE+EPINEFRINE IN THE POSTQUIRURGICAL PAIN OF THIRD MOLAR SURGERY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-000996-18-ES
Enrollment
Unknown
Registered
2015-02-16
Start date
2015-04-23
Completion date
Unknown
Last updated
2015-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

THIRD MOLAR REMOVING

Interventions

Trade Name: Articaina-epinefrina Product Name: Articaina-Epinefrina Product Code: Ultracain Pharmaceutical Form: Injection Trade Name: Dexametasona Product Name: Dexametasona Product Code: Dexametaso

Sponsors

Complejo Hospitalario Torrecárdenas
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. ADULT PATIENTS BETWEEN 18-45 YEARS OLD, AGE RANGE IN THAT USUALLY , THE THIRD MOLAR EMERGE OR PRODUCE THE DIFFERENT PÀTOLOGIES DERIVATES OF INCOMPLETE OR NOT ,EMERGING OF THIS ONE. 2. MEN AND WOMEN WIL BE SELECTED. 3 ONLY ONE PROCEDURE BY ONLY ONE SURGICAL ACT, I.E.,ONLY ONE EXTRACTION FOR EACH PATIENT AND INCIDENT. 4 PROCEDURE DONE UNDER LOCAL ANESTHESIA. 5 PATIENTS WHO HAVE AUTHORIZED THIRD REMOVING, SIGNING THE PATIENT INFORMATION FORM. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.PATIENTS UNDER 18 OR HIGHER 46 YEARS OLD. 2. MULTIPLE PROCEDURE, I.E., MORE THAN ONE EXTRACTION IN THE SAME SURGICAL ACT. 3 ANTICOAGULATED PATIENTS. 4. PATIENTS UNDER ONCOLOGICAL TREATMENT. 5. PATIENTS UNDER BISPHOSPHONATES TREATMENT 6. PATIENTS WTITH SISTEMIC PATHOLOGY THAT SHOULD BE PRODUCED INTERFERENCES WITH THE RESULT. 7. THIRD MOLAR WITH ODONTOGENIC CYST ASSOCIATES. 8. PATIENTS WHO HAVE RECIVIED LOCOREGIONAL RADIOTHERAPIC TREATMENT 9. PREVIOUS SURGERY IN THE INFERIOR RETROMOLAR TRIANGULE. 10 MENTAL DISSABILITY PATIENTS 11. PATIENETSWHO HAVE BEEN OPERATED UNDER GENERAL ANESTHESIA OR SEDATTION. 12. PRESENCE OF ACTIVE DISCHARGE INFECTION IN THE TIME OF SURGERY 13 PATIENTS WITH ALLERGIES AND/OR INTOLERANCE TO THE DRUGS THAT THIS STUDY USES. 14. PATIENTS WHO HAVE ALLERGIES TO BETALACTAMICS OR NSAID. 15. PREGNANT WOMEN OR WITH POSSIBILITY ( CHECKED WITH PREGNANT TEST) 16. PATIENTS WHO DON´T WANT, AUTHORIZE TO ENJOY IN THE STUDY OR NOT UNTHERSTAND THE SPANISH LANGUAGE. 17 ANY MEDICAL OR SURGICAL CONDITION THAT , UNDER THE RESEARCHER JUDGMENT, PUTS THE PATIENT UNDER DANGER SITUATION OR TO PREVENT THE PATIENT DON´T MEET THE REQUERIMENTS OR FINISH THE STUDY.

Design outcomes

Primary

MeasureTime frame
Main Objective: TO EVALUATE THE EFFECT AND THE SECURITY OF ARTICAINE-EPINEFRINE, BIPIVACAINE+DEXAMETASONE( THOSE LAST ONE ASSOCIATES ) AGAINST ARTICAINE-EPINEFRINE IN THE CONTROL OF POSTQUIRURGICAL PAIN AFTER THE INFERIOR THIRD MOLAR SURGERY;Secondary Objective: NOT APPLICABLE;Primary end point(s): TO EVALUATE THE EFFECT AND THE SECURITY OF ARTICAINE-EPINEFRINE, BIPIVACAINE+DEXAMETASONE( THOSE LAST ONE ASSOCIATES ) AGAINST ARTICAINE-EPINEFRINE IN THE CONTROL OF POSTQUIRURGICAL PAIN AFTER THE INFERIOR THIRD MOLAR SURGERY.;Timepoint(s) of evaluation of this end point: 24 HOURS

Secondary

MeasureTime frame
Secondary end point(s): NOT APPLICABLE;Timepoint(s) of evaluation of this end point: NOT APPLICABLE

Countries

Spain

Contacts

Public ContactFIBAO

FIBAO

jgalvan@fibao.es950016901

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026