Overview

This trial is active, not recruiting.

Conditions impacted third molar tooth, tooth extraction status nos
Treatment mandibular third molar surgery
Sponsor Lithuanian University of Health Sciences
Collaborator University of Trieste
Start date February 2015
End date December 2016
Trial size 110 participants
Trial identifier NCT02519426, J&D Classification Validation

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score lower than 9.
mandibular third molar surgery
Mandibular third molar surgery is a mandibular wisdom tooth removal procedure in which surgical access is required to completely remove a tooth. Even if the tooth is visible in the mouth without surgically exposing it, surgical techniques may be necessary to remove the tooth. This includes sectioning the tooth into two or more pieces, corticotomy, and removal with forceps and elevators, whether or not a soft tissue incision is made.
Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score higher than 9.
mandibular third molar surgery
Mandibular third molar surgery is a mandibular wisdom tooth removal procedure in which surgical access is required to completely remove a tooth. Even if the tooth is visible in the mouth without surgically exposing it, surgical techniques may be necessary to remove the tooth. This includes sectioning the tooth into two or more pieces, corticotomy, and removal with forceps and elevators, whether or not a soft tissue incision is made.
Mandibular third molar surgery patients with Pell Gregory index Class 1A, Class 1B, Class 1C, or Class 2A
mandibular third molar surgery
Mandibular third molar surgery is a mandibular wisdom tooth removal procedure in which surgical access is required to completely remove a tooth. Even if the tooth is visible in the mouth without surgically exposing it, surgical techniques may be necessary to remove the tooth. This includes sectioning the tooth into two or more pieces, corticotomy, and removal with forceps and elevators, whether or not a soft tissue incision is made.
Mandibular third molar surgery patients with Pell Gregory index Class 2B, Class 2C, Class 3A, Class 3B, or Class 3C
mandibular third molar surgery
Mandibular third molar surgery is a mandibular wisdom tooth removal procedure in which surgical access is required to completely remove a tooth. Even if the tooth is visible in the mouth without surgically exposing it, surgical techniques may be necessary to remove the tooth. This includes sectioning the tooth into two or more pieces, corticotomy, and removal with forceps and elevators, whether or not a soft tissue incision is made.
Mandibular third molar surgery patients with Winter predicted index of Mesio-Angular, Disto-Angular or Vertical impaction
mandibular third molar surgery
Mandibular third molar surgery is a mandibular wisdom tooth removal procedure in which surgical access is required to completely remove a tooth. Even if the tooth is visible in the mouth without surgically exposing it, surgical techniques may be necessary to remove the tooth. This includes sectioning the tooth into two or more pieces, corticotomy, and removal with forceps and elevators, whether or not a soft tissue incision is made.
Mandibular third molar surgery patients with Winter predicted index of Horizontal, Buccal / Lingual Obliquity, Transverse, Inverse impaction
mandibular third molar surgery
Mandibular third molar surgery is a mandibular wisdom tooth removal procedure in which surgical access is required to completely remove a tooth. Even if the tooth is visible in the mouth without surgically exposing it, surgical techniques may be necessary to remove the tooth. This includes sectioning the tooth into two or more pieces, corticotomy, and removal with forceps and elevators, whether or not a soft tissue incision is made.

Primary Outcomes

Measure
Duration of the mandibular third molar surgery
time frame: Up to 2 hours

Secondary Outcomes

Measure
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
NSAID assumption
time frame: 7 days

Eligibility Criteria

Male or female participants from 16 years up to 90 years old.

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

Additional Information

Official title Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial
Principal investigator Povilas Daugela, DDS, Assist.
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Lithuanian University of Health Sciences.