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

• Conditions: Impacted Third Molar Tooth; Tooth Extraction Status Nos

• Registration Number: NCT02519426
• Lead Sponsor: Lithuanian University of Health Sciences

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-09
• Study First Posted: 2015-08-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of the mandibular third molar surgery	Up to 2 hours	Duration of the surgical procedure is counted from the beginning of surgical manipulations to complete removal of mandibular wisdom tooth and wound closure if applicable.

Secondary Outcome Measures

Name	Time	Method
Composite assessment of the surgical technique and of intra - and post-operative complications	7 days	Surgical approach (open flap, flapless), surgical technique (simple mobilization of the tooth, ostectomy, coronectomy, roots separation), used surgical devices (forceps and elevators, rotary carbide bur, rotary diamond bur, piezosurgery), as well as intra-operative side effects (apex fracture, inferior alveolar artery bleeding, fragment displacement in soft tissues, mandible fracture) and type of wound are evaluated.
Pain and Discomfort assessment with VAS scale	7 days	surgery with 10 grade VAS scale, where 0=no pain, 10=Worst possible, unbearable, excruciating pain.
NSAID assumption	7 days	Patient every day NSAID (Ibuprofen 400 mg) tablet count taken in in the consecutive 7 days after surgery.

Trial Locations

Locations (2)

The University of Trieste; 🇮🇹 Trieste, Italy

Lithuanian University of Health Sciences; 🇱🇹 Kaunas, Lithuania