|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 April 2016 |
|
Main ID: |
NCT02519426 |
|
Date of registration:
|
03/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical Validation of a Novel Classification for Predicting Surgical Complexity in Mandibular Wisdom Teeth Surgery
|
|
Scientific title:
|
Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial |
|
Date of first enrolment:
|
February 2015 |
|
Target sample size:
|
110 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02519426 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Italy
|
Lithuania
| | | | | | |
|
Contacts
|
|
Name:
|
Povilas Daugela, DDS, Assist. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Lithuanian University of Health Sciences |
|
|
Name:
|
Federico Berton, DDS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The University of Trieste |
|
|
Name:
|
Roberto Di Lenarda, DDS,MSc,Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The University of Trieste |
|
|
Name:
|
Claudio Stacchi, DDS,MSc,Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The University of Trieste |
|
|
Name:
|
Teresa Lombardi, DDS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The University of Trieste |
|
|
Name:
|
Gintaras Juodzbalys, DDS,PhD,Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Lithuanian University of Health Sciences |
|
|
Name:
|
Tautvydas Andriulionios, DDS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Lithuanian University of Health Sciences |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Male and female patients with an age comprised between 16 to 90 years
- Healthy patients ( ASA (American Society of Anesthesiologists) Physical status index
= 2)
- CBCT and/or OPG performed not before than 12 months before surgery
- Complete roots formation of 38 or 48 at CBCT and/or OPG examination
- Signed informed consent
Exclusion Criteria:
- Smoking > 10 cigarettes per day
- Presence of any neoplastic lesion (benign or malignant), clinically or radiologically
evaluable, at the site or close to the impacted tooth
- Presence of any radiolucent lesion >1 cm at impacted tooth level
Age minimum:
16 Years
Age maximum:
90 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Impacted Third Molar Tooth
|
|
Tooth Extraction Status Nos
|
|
Intervention(s)
|
|
Procedure: Mandibular third molar surgery
|
|
Primary Outcome(s)
|
|
Duration of the mandibular third molar surgery
[Time Frame: Up to 2 hours]
|
|
Secondary Outcome(s)
|
|
NSAID assumption
[Time Frame: 7 days]
|
|
Composite assessment of the surgical technique and of intra - and post-operative complications
[Time Frame: 7 days]
|
|
Pain and Discomfort assessment with VAS scale
[Time Frame: 7 days]
|
|
Secondary ID(s)
|
|
J&D Classification Validation
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|