NCT02519426|Unknown
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Sponsor study identifier
observational
110
2 countries
2
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 3, 2015
Actual (reported)August 11, 2015
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score lower than 9.
Mandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score higher than 9.
Mandibular third molar surgery patients with Pell Gregory index Class 1A, Class 1B, Class 1C, or Class 2A
Mandibular third molar surgery patients with Pell Gregory index Class 2B, Class 2C, Class 3A, Class 3B, or Class 3C
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.
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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.
The University of Trieste
Trieste, 34149, Italy
Lithuanian University of Health Sciences
Kaunas, 50009, Lithuania
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.
Claudio Stacchi, DDS,MSc,Prof
The University of Trieste
Gintaras Juodzbalys, DDS,PhD,Prof
The Lithuanian University of Health Sciences
Povilas Daugela, DDS, Assist.
The Lithuanian University of Health Sciences
Federico Berton, DDS
The University of Trieste
First Submitted
August 3, 2015
First Posted
August 11, 2015
Study Start
February 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)Trapezoidal Flap vs. Envelope Flap in Mandibular Third Molar Extraction.
Mandibular third molar surgery patients with Winter predicted index of Mesio-Angular, Disto-Angular or Vertical impaction
Mandibular third molar surgery patients with Winter predicted index of Horizontal, Buccal / Lingual Obliquity, Transverse, Inverse impaction
Contact the study team to confirm eligibility.
Teresa Lombardi, DDS
The University of Trieste
Roberto Di Lenarda, DDS,MSc,Prof
The University of Trieste
Tautvydas Andriulionios, DDS
The Lithuanian University of Health Sciences
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 2, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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