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| Name | Class |
|---|---|
| University of Trieste | OTHER |
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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.
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\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cumulative complexity score <9 | Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score lower than 9. |
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| Cumulative complexity score y≥9 | Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score higher than 9. |
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| Pell Gregory index <Class 2B | Mandibular third molar surgery patients with Pell Gregory index Class 1A, Class 1B, Class 1C, or Class 2A |
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| Pell Gregory index ≥Class 2B | Mandibular third molar surgery patients with Pell Gregory index Class 2B, Class 2C, Class 3A, Class 3B, or Class 3C |
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| Winter index <Horizontal impaction | Mandibular third molar surgery patients with Winter predicted index of Mesio-Angular, Disto-Angular or Vertical impaction |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular third molar surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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A total number of 110 (including eventual drop outs) third molar surgery patients will be selected randomly. One tooth per patient is going to be evaluated. 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. In total 104 extraction are going to be evaluated. Patients will be divided into two groups according to Juodzbalys and Daugela classification score (x<9>y). Sample size of 52 subjects per group was calculated to detect a mean difference between the two groups of 10 minutes with an expected SD of 18 minutes. Power was set at 80% and alpha at 0.05.
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Stacchi, DDS,MSc,Prof | The University of Trieste | Study Chair |
| Gintaras Juodzbalys, DDS,PhD,Prof | The Lithuanian University of Health Sciences | Study Chair |
| Povilas Daugela, DDS, Assist. | The Lithuanian University of Health Sciences | Principal Investigator |
| Federico Berton, DDS | The University of Trieste | Principal Investigator |
| Teresa Lombardi, DDS | The University of Trieste | Principal Investigator |
| Roberto Di Lenarda, DDS,MSc,Prof | The University of Trieste | Principal Investigator |
| Tautvydas Andriulionios, DDS | The Lithuanian University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Trieste | Trieste | 34149 | Italy | |||
| Lithuanian University of Health Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24422029 | Background | 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. |
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| Winter index ≥Horizontal impaction | Mandibular third molar surgery patients with Winter predicted index of Horizontal, Buccal / Lingual Obliquity, Transverse, Inverse impaction |
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| 7 days |
| 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 |
| NSAID assumption | Patient every day NSAID (Ibuprofen 400 mg) tablet count taken in in the consecutive 7 days after surgery. | 7 days |
| Kaunas |
| 50009 |
| Lithuania |
| ID | Term |
|---|---|
| D061222 | Lingual Nerve Injuries |
| ID | Term |
|---|---|
| D061221 | Trigeminal Nerve Injuries |
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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