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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02519426
Enrollment
110
Registered
2015-08-11
Start date
2015-02-28
Completion date
2016-12-31
Last updated
2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth, Tooth Extraction Status Nos

Keywords

Third molar, Classification, Inferior alveolar nerve, Lingual nerve injuries, Mandibular canal

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.

Interventions

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.

Sponsors

University of Trieste
CollaboratorOTHER
Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of the mandibular third molar surgeryUp to 2 hoursDuration 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

MeasureTime frameDescription
Composite assessment of the surgical technique and of intra - and post-operative complications7 daysSurgical 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 scale7 dayssurgery with 10 grade VAS scale, where 0=no pain, 10=Worst possible, unbearable, excruciating pain.
NSAID assumption7 daysPatient every day NSAID (Ibuprofen 400 mg) tablet count taken in in the consecutive 7 days after surgery.

Countries

Italy, Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026