Phentolamines and their role in everyday dentistry

Phase 1

• Conditions: Patients with dental decay, root canal treatment or tooth to be extracted will be studied; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2020-000714-15-BE
• Lead Sponsor: B ERASME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-26
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Critères d’inclusions :
- Patients from 10 to 65 years.

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Critères d’exclusions :
- Patients less than 10 years.
- Patients presenting former contraindication with receiving adrenaline injection ( common local anesthesia)
(Asmathique cortico-dépendant, cancer of former cancer of adrenal gland, pregnant woman, Patient with diabete uncontrolled).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Showing that the utilisation of Phentolamines mesylates, statistically reduced the residual anaesthesia after a dental routine care rather than no utilisation.;Secondary Objective: Comparison of satisfaction induced for the patients by answering a questionnaire.;Primary end point(s): Reaching the number of patients required (40) ;Timepoint(s) of evaluation of this end point: MAY 2020

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Reaching timepoint N*1;Timepoint(s) of evaluation of this end point: May 2020