Impacted Third Molar ToothNCT02519426
Clinical Validation of a Novel Classification for Predicting Surgical Complexity in Mandibular Wisdom Teeth Surgery
An observational study of Impacted Third Molar Tooth and Tooth Extraction Status Nos, run by Lithuanian University of Health Sciences at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Impacted Third Molar Tooth, Tooth Extraction Status Nos
- What is being tested?
- Mandibular third molar surgery
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial
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.
Read the 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.
- Being tested
- Mandibular third molar surgery
- Keywords
- Third molar, Classification, Inferior alveolar nerve, Lingual nerve injuries, Mandibular canal
- Medical subject headings
- Lingual Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular third molar surgeryProcedure or 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: Mandibular third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 7 days
NSAID assumption
Patient every day NSAID (Ibuprofen 400 mg) tablet count taken in in the consecutive 7 days after surgery.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Trieste
- Responsible party
- Principal investigator, Povilas Daugela, Lithuanian University of Health Sciences
- Investigators
- Claudio Stacchi, DDS,MSc,Prof, Study chair, The University of TriesteGintaras Juodzbalys, DDS,PhD,Prof, Study chair, The Lithuanian University of Health SciencesPovilas Daugela, DDS, Assist., Principal investigator, The Lithuanian University of Health SciencesFederico Berton, DDS, Principal investigator, The University of TriesteTeresa Lombardi, DDS, Principal investigator, The University of TriesteRoberto Di Lenarda, DDS,MSc,Prof, Principal investigator, The University of TriesteTautvydas Andriulionios, DDS, Principal investigator, The Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519426
- Sponsor's protocol ID
- J&D Classification Validation
- Status last verified
- Mar 2016
- First submitted
- 3 Aug 2015
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24422029
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of a Novel Classification for Predicting Surgical Complexity of Impacted Mandibular Third Molar Extraction: an Observational Clinical Trial
- ClinicalTrials.gov ID
- NCT02519426
- Acronym / sponsor ID
- J&D Classification Validation
- Keywords
- Third molar, Classification, Inferior alveolar nerve, Lingual nerve injuries, Mandibular canal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- University of Trieste
- Study start
- Feb 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cumulative complexity score <9 | – | Procedure: Mandibular third molar surgeryMandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score lower than 9. |
| Cumulative complexity score y≥9 | – | Procedure: Mandibular third molar surgeryMandibular third molar surgery patients with Juodzbalys and Daugela impacted mandibular third molars surgical extraction complexity index cumulative score higher than 9. |
| Pell Gregory index <Class 2B | – | Procedure: Mandibular third molar surgeryMandibular third molar surgery patients with Pell Gregory index Class 1A, Class 1B, Class 1C, or Class 2A |
| Pell Gregory index ≥Class 2B | – | Procedure: Mandibular third molar surgeryMandibular third molar surgery patients with Pell Gregory index Class 2B, Class 2C, Class 3A, Class 3B, or Class 3C |
| Winter index <Horizontal impaction | – | Procedure: Mandibular third molar surgeryMandibular third molar surgery patients with Winter predicted index of Mesio-Angular, Disto-Angular or Vertical impaction |
| Winter index ≥Horizontal impaction | – | Procedure: Mandibular third molar surgeryMandibular third molar surgery patients with Winter predicted index of Horizontal, Buccal / Lingual Obliquity, Transverse, Inverse impaction |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular third molar surgeryMandibular 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. | Procedure or surgery | 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 |
Primary outcome
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.
3 secondary outcomes
Composite assessment of the surgical technique and of intra - and post-operative complications
Time frame: 7 days
Pain and Discomfort assessment with VAS scale
Time frame: 7 days
NSAID assumption
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
- Background: PubMed 24422029Juodzbalys 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Stacchi, DDS,MSc,Prof study chair
The University of Trieste
Gintaras Juodzbalys, DDS,PhD,Prof study chair
The Lithuanian University of Health Sciences
Povilas Daugela, DDS, Assist. principal investigator
The Lithuanian University of Health Sciences
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Third Molar Tooth and Tooth Extraction Status Nos, run by Lithuanian University of Health Sciences at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the mandibular third molar surgery (time frame: Up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02519426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2016.