Clinical trial NCT02519426: Clinical Validation of a Novel Classification for Predicting Surgical Complexity in Mandibular Wisdom Teeth Surgery
Official title: Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Impacted Third Molar Tooth
Tooth Extraction Status Nos
Keywords: Third molar
Classification
Inferior alveolar nerve
Lingual nerve injuries
Mandibular canal
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: University of Trieste
First posted: 2015-08-11
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total number of 110 (including eventual drop outs) third molar surgery patients will be selected randomly. One tooth per patient is going to be evaluated. It should be noted that if a single patient has a bilateral impacted tooth to be extracted it will be randomly selected only one to be analyzed. In total 104 extraction are going to be evaluated. Patients will be divided into two groups according to Juodzbalys and Daugela classification score (x\<9\>y). Sample size of 52 subjects per group was calculated to detect a mean difference between the two groups of 10 minutes with an expected SD of 18 minutes. Power was set at 80% and alpha at 0.05.

Brief summary: The study evaluates and validates a new classification proposed by Juodzbalys and Daugela in 2013 predicting the complexity of impacted mandibular third molars surgical extraction, comparing it with other two, scientifically approved (Pell and Gregory, Winter) classifications.

Detailed description: The extraction of mandibular impacted wisdom teeth is the most widespread surgical procedure performed in oral surgery. There are many situations indicating the extraction of those teeth as well as risks and protective factors that may contraindicate it. A reliable classification predicting the complexity of the surgical procedure and the related risk of complications would greatly help the surgeon in the diagnostic phase.

The aim of the study is to evaluate if the classification proposed by Juodzbalys and Daugela in 2013 could be effective in predicting the complexity of impacted mandibular third molars surgical extraction, and to compare its effectiveness with commonly used Pell and Gregory, Winter classifications.

A blind expert surgeon will assess postoperatively all CBCTs (Cone beam computed tomographies) and OPGs (orthopantomographs) not older than 12 months, and will assign the score for each extracted tooth for the three classification (Juodzbalys and Daugela - Pell and Gregory - Winter). Duration of the surgical procedure, assessment of the surgical technique and of intra- and post-operative complications will be considered as the main parameters to evaluate surgical difficulty. VAS (Visual Analogue Scale) pain score and NSAID (Nonsteroidal anti-inflammatory drug) pills count taken by each patient of the 7 days postoperative period will be also evaluated.

Statistical unit analyzed will be the single tooth. It should be noted that if a single patient has a bilateral impacted tooth to be extracted it will be randomly selected only one to be analyzed. Patients will be divided into two groups according to Juodzbalys and Daugela classification score (x\<9≤y), two groups according to each predicted extraction difficulty to Pell Gregory (x\<Class 2B≤y) and Winter (x\<Horizontal impaction≤y) classifications.

Eligibility 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

Primary outcomes:
measure: Duration of the mandibular third molar surgery
timeFrame: Up to 2 hours
Secondary outcomes:
measure: Composite assessment of the surgical technique and of intra - and post-operative complications
timeFrame: 7 days
measure: Pain and Discomfort assessment with VAS scale
timeFrame: 7 days
measure: NSAID assumption
timeFrame: 7 days
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: The University of Trieste
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: The University of Trieste
name: Claudio Stacchi, DDS,MSc,Prof
role: STUDY_CHAIR
affiliation: The Lithuanian University of Health Sciences
name: Gintaras Juodzbalys, DDS,PhD,Prof
role: STUDY_CHAIR
affiliation: The Lithuanian University of Health Sciences
name: Povilas Daugela, DDS, Assist.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Trieste
name: Federico Berton, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Trieste
name: Teresa Lombardi, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Trieste
name: Roberto Di Lenarda, DDS,MSc,Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: The Lithuanian University of Health Sciences
name: Tautvydas Andriulionios, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Juodzbalys G, Daugela P. Mandibular third molar impaction: review of literature and a proposal of a classification. J Oral Maxillofac Res. 2013 Jul 1;4(2):e1. doi: 10.5037/jomr.2013.4201.