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

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ClinicalTrials.gov Identifier: NCT02519426
Recruitment Status : Unknown
Verified March 2016 by Povilas Daugela, Lithuanian University of Health Sciences.
Recruitment status was:  Active, not recruiting
First Posted : August 11, 2015
Last Update Posted : March 2, 2016
Sponsor:
Collaborator:
University of Trieste
Information provided by (Responsible Party):
Povilas Daugela, Lithuanian University of Health Sciences

Tracking Information
First Submitted Date August 3, 2015
First Posted Date August 11, 2015
Last Update Posted Date March 2, 2016
Study Start Date February 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2015)
Duration of the mandibular third molar surgery [ Time Frame: Up to 2 hours ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 9, 2015)
  • Composite assessment of the surgical technique and of intra - and post-operative complications [ Time Frame: 7 days ]
    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.
  • Pain and Discomfort assessment with VAS scale [ Time Frame: 7 days ]
    surgery with 10 grade VAS scale, where 0=no pain, 10=Worst possible, unbearable, excruciating pain.
  • NSAID assumption [ Time Frame: 7 days ]
    Patient every day NSAID (Ibuprofen 400 mg) tablet count taken in in the consecutive 7 days after surgery.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Validation of a Novel Classification for Predicting Surgical Complexity in Mandibular Wisdom Teeth Surgery
Official Title Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Impacted Third Molar Tooth
  • Tooth Extraction Status Nos
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.
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: 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
    Intervention: Procedure: Mandibular third molar surgery
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 9, 2015)
110
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy,   Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number NCT02519426
Other Study ID Numbers J&D Classification Validation
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Povilas Daugela, Lithuanian University of Health Sciences
Study Sponsor Lithuanian University of Health Sciences
Collaborators University of Trieste
Investigators
Study Chair: Claudio Stacchi, DDS,MSc,Prof The University of Trieste
Study Chair: Gintaras Juodzbalys, DDS,PhD,Prof The Lithuanian University of Health Sciences
Principal Investigator: 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
PRS Account Lithuanian University of Health Sciences
Verification Date March 2016