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

Impacted Third Molar Tooth Clinical Trial

Official title:

Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02519426
• Other study ID #: J&D Classification Validation
• Status: Active, not recruiting
• Phase: N/A
• First received: August 3, 2015
• Last updated: March 1, 2016
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth Extraction Status Nos
• Tooth, Impacted

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	The University of Trieste	Trieste
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	University of Trieste

Countries where clinical trial is conducted

Italy,  Lithuania, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the mandibular third molar surgery	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.	Up to 2 hours	No
Secondary	Composite assessment of the surgical technique and of intra - and post-operative complications	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.	7 days	No
Secondary	Pain and Discomfort assessment with VAS scale	surgery with 10 grade VAS scale, where 0=no pain, 10=Worst possible, unbearable, excruciating pain.	7 days	No
Secondary	NSAID assumption	Patient every day NSAID (Ibuprofen 400 mg) tablet count taken in in the consecutive 7 days after surgery.	7 days	No