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

NCT02519426 | Unknown

• 1 other identifier: J&D Classification Validation
• Study Type: observational
• Target: 110
• Locations: 2 countries
• Sites: 2

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.

Conditions

Impacted Third Molar Tooth; Tooth Extraction Status Nos

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Composite assessment of the surgical technique and of intra - and post-operative complications

  7 days

• Pain and Discomfort assessment with VAS scale

  7 days

• NSAID assumption

  7 days

Study Arms (6)

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.

Procedure: Mandibular third molar surgery

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.

Procedure: Mandibular third molar surgery

Pell Gregory index <Class 2B

Mandibular third molar surgery patients with Pell Gregory index Class 1A, Class 1B, Class 1C, or Class 2A

Procedure: Mandibular third molar surgery

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

Procedure: Mandibular third molar surgery

Winter index <Horizontal impaction

Mandibular third molar surgery patients with Winter predicted index of Mesio-Angular, Disto-Angular or Vertical impaction

Procedure: Mandibular third molar surgery

Winter index ≥Horizontal impaction

Mandibular third molar surgery patients with Winter predicted index of Horizontal, Buccal / Lingual Obliquity, Transverse, Inverse impaction

Procedure: Mandibular third molar surgery

Interventions

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.

Cumulative complexity score <9; Cumulative complexity score y≥9; Pell Gregory index <Class 2B; Pell Gregory index ≥Class 2B; Winter index <Horizontal impaction; Winter index ≥Horizontal impaction

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• University of Trieste: collaborator

Study Sites (2)

The University of Trieste

Trieste, 34149, Italy

Location

Lithuanian University of Health Sciences

Kaunas, 50009, Lithuania

Location

Related 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.

  PMID: 24422029 BACKGROUND

MeSH Terms

Conditions

Lingual Nerve Injuries

Condition Hierarchy (Ancestors)

Trigeminal Nerve Injuries; Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 11, 2015
• Study Start: February 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 2, 2016

Record last verified: 2016-03

Locations

LI (1); IT (1)