Clinical Validation of a Novel Classification for Predicting Surgical Complexity in Mandibular Wisdom Teeth Surgery

Lithuanian University of Health Sciences

Status

Unknown

Conditions

Impacted Third Molar Tooth

Tooth Extraction Status Nos

Treatments

Procedure: Mandibular third molar surgery

Study type

Observational

Funder types

Other

Identifiers

NCT02519426

J&D Classification Validation

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 estimated patients

Sex

All

Ages

16 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

110 participants in 6 patient groups

Cumulative complexity score <9

Description:

Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score lower than 9.

Treatment:

Procedure: Mandibular third molar surgery

Cumulative complexity score y≥9

Description:

Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score higher than 9.

Treatment:

Procedure: Mandibular third molar surgery

Pell Gregory index <Class 2B

Description:

Mandibular third molar surgery patients with Pell Gregory index Class 1A, Class 1B, Class 1C, or Class 2A

Treatment:

Procedure: Mandibular third molar surgery

Pell Gregory index ≥Class 2B

Description:

Mandibular third molar surgery patients with Pell Gregory index Class 2B, Class 2C, Class 3A, Class 3B, or Class 3C

Treatment:

Procedure: Mandibular third molar surgery