Impacted Third Molar ToothNCT06320665
Assessment of Vertical Pattern in Correlation With Third Molar Inclusion : A 3D CBCT Analysis
An observational study of Impacted Third Molar Tooth, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The objective is to compare the sagittal and vertical skeletal parameters of patients with an impacted third molar. Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction). Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Radiographic measurement
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: French adults with at least one impacted third molar
Who may be able to join
- CMV stage 5 on lateral radiography (end of growth)
- at least one impacted third molar at minimum Nolla stage 6 development
Who cannot join
- Previous maxillofacial trauma
- Growing patients
- Missing permanent tooth or early avulsion
- Dysplasia
- Dentofacial deformities
- Endocrinological pathologies with implications for maxillofacial growth
Show all 10Show fewer
- Syndromes
- History of maxillofacial or orthognathic surgery
- History of orthodontic treatment
- Incomplete data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Département d'Orthopédie dento-faciale
Nancy, 54000
Mathilde Laé, intern, + 33 7 81 8938 50, mathildelae@hotmail.fr
Bart Vande Vannet, professor
About this study
Official title: Assessment of Vertical Pattern in Correlation With Third Molar Inclusion : a 3D CBCT Analysis
The objective is to compare the sagittal and vertical skeletal parameters of patients with an impacted third molar.
Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction).
The inclusion characteristics of third molars will also be analyzed, to see the links between typology and inclusion. The principal hypothesis is no significant difference in third molar inclusion patterns in relation to skeletal divergence.
Read the detailed description
The study is a non-interventional (observational) research involving the human person, research on existing data (retrospective study) and samples dealing with dentofacial orthopedics.
This study analyzes third molar inclusion patterns in relation with the skeletal characteristics, sagittal and vertical typology.
This is a comparative retrospective study of radiographs in three dimensions before any orthodontic treatment. The patients studied are at Bacchetti CS stage 5 (adults), and the third molar must be at least at Nolla stage 6 of formation.
There is no control group but there are subgroups depending of the skeletal characterics.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Radiographic measurement
- Keywords
- Cone beam ct, third molar, Vertical dimension, Impacted teeth, Orthodontic, Adult, Skeletal pattern
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiographic measurementOther
Measurements taken on 3D radiographs, to assess third molar inclusion and skeletal typology (vertical and sagittal)
| Study group | Role | What they receive |
|---|---|---|
| Class I | Patient with class I occlusion, with at least one impacted third molar Receives: Other: Radiographic measurement | |
| Class II | Patients with class II malocclusion, with at least one impacted third molar Receives: Other: Radiographic measurement | |
| Class III | Patients with class III malocclusion, with at least one impacted third molar Receives: Other: Radiographic measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between the occlusal plane and the second molar
Depth of the third molar in mm
Measured: One day
Angle of the third molar
The coronal-radicular axis of the mandibular third molar, and the occlusal plane of the mandibular 1st and 2nd molars, when these are in a normal, functional position on the arch (in degrees)
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Dec 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Other
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANDE VANNET Bart, Central Hospital, Nancy, France
- Investigators
- Bart VANDE VANNET, PhD, Study director, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320665
- Sponsor's protocol ID
- 2024PI003
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Idris AM, Al-Mashraqi AA, Abidi NH, Vani NV, Elamin EI, Khubrani YH, Sh Alhazmi A, Alamir AH, Fageeh HN, Meshni AA, Mashyakhy MH, Makrami AM, Gareeb Alla Abdalla A, Jafer M. Third molar impaction in the Jazan Region: Evaluation of the prevalence and clinical presentation. Saudi Dent J. 2021 May;33(4):194-200. doi: 10.1016/j.sdentj.2020.02.004. Epub 2020 Mar 4.
PubMed 34025081Costa MG, Pazzini CA, Pantuzo MC, Jorge ML, Marques LS. Is there justification for prophylactic extraction of third molars? A systematic review. Braz Oral Res. 2013 Mar-Apr;27(2):183-8.
PubMed 23538430Hounsome J, Pilkington G, Mahon J, Boland A, Beale S, Kotas E, Renton T, Dickson R. Prophylactic removal of impacted mandibular third molars: a systematic review and economic evaluation. Health Technol Assess. 2020 Jun;24(30):1-116. doi: 10.3310/hta24300.
PubMed 32589125Tassoker M, Kok H, Sener S. Is There a Possible Association between Skeletal Face Types and Third Molar Impaction? A Retrospective Radiographic Study. Med Princ Pract. 2019;28(1):70-74. doi: 10.1159/000495005. Epub 2018 Oct 31.
PubMed 30380552Legovic M, Legovic I, Brumini G, Vandura I, Cabov T, Ovesnik M, Mestrovic S, Slaj M, Skrinjaric A. Correlation between the pattern of facial growth and the position of the mandibular third molar. J Oral Maxillofac Surg. 2008 Jun;66(6):1218-24. doi: 10.1016/j.joms.2007.12.013.
PubMed 18486787Aoun Y, Husseini B, Younes R, Ghosn N, Bouserhal J. Assessment of lower third molar space: A comparative radiographic study. Dentomaxillofac Radiol. 2022 Jul 1;51(5):20220049. doi: 10.1259/dmfr.20220049. Epub 2022 May 4.
PubMed 35466682Zamora N, Llamas JM, Cibrian R, Gandia JL, Paredes V. A study on the reproducibility of cephalometric landmarks when undertaking a three-dimensional (3D) cephalometric analysis. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e678-88. doi: 10.4317/medoral.17721.
PubMed 22322503Li C, Teixeira H, Tanna N, Zheng Z, Chen SHY, Zou M, Chung CH. The Reliability of Two- and Three-Dimensional Cephalometric Measurements: A CBCT Study. Diagnostics (Basel). 2021 Dec 7;11(12):2292. doi: 10.3390/diagnostics11122292.
PubMed 34943528Carter K, Worthington S. Predictors of Third Molar Impaction: A Systematic Review and Meta-analysis. J Dent Res. 2016 Mar;95(3):267-76. doi: 10.1177/0022034515615857. Epub 2015 Nov 11.
PubMed 26561441Bin Rubaia'an MA, Neyaz A, Talic F, Alkhamis A, Alghabban A, Assari A. The Association Between Skeletal Facial Types and Third Molars Impaction in a Saudi Arabian Subpopulation: A CBCT Study. Clin Cosmet Investig Dent. 2023 Aug 15;15:143-156. doi: 10.2147/CCIDE.S419325. eCollection 2023.
PubMed 37601239Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
PubMed 12169031Hagg U, Taranger J. Dental emergence stages and the pubertal growth spurt. Acta Odontol Scand. 1981;39(5):295-306. doi: 10.3109/00016358109162293.
PubMed 6950638Hasan KM, Sobhana CR, Rawat SK, Singh D, Mongia P, Fakhruddin A. Third molar impaction in different facial types and mandibular length: A cross-sectional study. Natl J Maxillofac Surg. 2021 Jan-Apr;12(1):83-87. doi: 10.4103/njms.NJMS_111_20. Epub 2021 Mar 16.
PubMed 34188406Mollaoglu N, Cetiner S, Gungor K. Patterns of third molar impaction in a group of volunteers in Turkey. Clin Oral Investig. 2002 Jun;6(2):109-13. doi: 10.1007/s00784-001-0144-1.
PubMed 12166710Jaron A, Trybek G. The Pattern of Mandibular Third Molar Impaction and Assessment of Surgery Difficulty: A Retrospective Study of Radiographs in East Baltic Population. Int J Environ Res Public Health. 2021 Jun 3;18(11):6016. doi: 10.3390/ijerph18116016.
PubMed 34205078
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vertical Pattern in Correlation With Third Molar Inclusion : a 3D CBCT Analysis
- ClinicalTrials.gov ID
- NCT06320665
- Acronym / sponsor ID
- 2024PI003
- Conditions
- Impacted Third Molar Tooth
- Keywords
- Cone beam ct, third molar, Vertical dimension, Impacted teeth, Orthodontic, Adult, Skeletal pattern
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- 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 objective is to compare the sagittal and vertical skeletal parameters of patients with an impacted third molar.
Patients will be analyzed according to their skeletal characteristics: skeletal class (sagittal direction) and facial skeletal typology (vertical direction).
The inclusion characteristics of third molars will also be analyzed, to see the links between typology and inclusion. The principal hypothesis is no significant difference in third molar inclusion patterns in relation to skeletal divergence.
Detailed description
The study is a non-interventional (observational) research involving the human person, research on existing data (retrospective study) and samples dealing with dentofacial orthopedics.
This study analyzes third molar inclusion patterns in relation with the skeletal characteristics, sagittal and vertical typology.
This is a comparative retrospective study of radiographs in three dimensions before any orthodontic treatment. The patients studied are at Bacchetti CS stage 5 (adults), and the third molar must be at least at Nolla stage 6 of formation.
There is no control group but there are subgroups depending of the skeletal characterics.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Class I | – | Other: Radiographic measurementPatient with class I occlusion, with at least one impacted third molar |
| Class II | – | Other: Radiographic measurementPatients with class II malocclusion, with at least one impacted third molar |
| Class III | – | Other: Radiographic measurementPatients with class III malocclusion, with at least one impacted third molar |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- French adults with at least one impacted third molar
Key inclusion criteria (2 listed)
- CMV stage 5 on lateral radiography (end of growth)
- at least one impacted third molar at minimum Nolla stage 6 development
Key exclusion criteria (10 listed)
- Previous maxillofacial trauma
- Growing patients
- Missing permanent tooth or early avulsion
- Dysplasia
- Dentofacial deformities
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 |
|---|---|---|
| Radiographic measurementMeasurements taken on 3D radiographs, to assess third molar inclusion and skeletal typology (vertical and sagittal) | Other | Class I, Class II, Class III |
Primary outcome
Distance between the occlusal plane and the second molar
Time frame: One day
Depth of the third molar in mm
Angle of the third molar
Time frame: One day
The coronal-radicular axis of the mandibular third molar, and the occlusal plane of the mandibular 1st and 2nd molars, when these are in a normal, functional position on the arch (in degrees)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 34025081Idris AM, Al-Mashraqi AA, Abidi NH, Vani NV, Elamin EI, Khubrani YH, Sh Alhazmi A, Alamir AH, Fageeh HN, Meshni AA, Mashyakhy MH, Makrami AM, Gareeb Alla Abdalla A, Jafer M. Third molar impaction in the Jazan Region: Evaluation of the prevalence and clinical presentation. Saudi Dent J. 2021 May;33(4):194-200. doi: 10.1016/j.sdentj.2020.02.004. Epub 2020 Mar 4.
- Background: PubMed 23538430Costa MG, Pazzini CA, Pantuzo MC, Jorge ML, Marques LS. Is there justification for prophylactic extraction of third molars? A systematic review. Braz Oral Res. 2013 Mar-Apr;27(2):183-8.
- Background: PubMed 32589125Hounsome J, Pilkington G, Mahon J, Boland A, Beale S, Kotas E, Renton T, Dickson R. Prophylactic removal of impacted mandibular third molars: a systematic review and economic evaluation. Health Technol Assess. 2020 Jun;24(30):1-116. doi: 10.3310/hta24300.
- Background: PubMed 30380552Tassoker M, Kok H, Sener S. Is There a Possible Association between Skeletal Face Types and Third Molar Impaction? A Retrospective Radiographic Study. Med Princ Pract. 2019;28(1):70-74. doi: 10.1159/000495005. Epub 2018 Oct 31.
- Background: PubMed 18486787Legovic M, Legovic I, Brumini G, Vandura I, Cabov T, Ovesnik M, Mestrovic S, Slaj M, Skrinjaric A. Correlation between the pattern of facial growth and the position of the mandibular third molar. J Oral Maxillofac Surg. 2008 Jun;66(6):1218-24. doi: 10.1016/j.joms.2007.12.013.
- Background: PubMed 35466682Aoun Y, Husseini B, Younes R, Ghosn N, Bouserhal J. Assessment of lower third molar space: A comparative radiographic study. Dentomaxillofac Radiol. 2022 Jul 1;51(5):20220049. doi: 10.1259/dmfr.20220049. Epub 2022 May 4.
- Background: PubMed 22322503Zamora N, Llamas JM, Cibrian R, Gandia JL, Paredes V. A study on the reproducibility of cephalometric landmarks when undertaking a three-dimensional (3D) cephalometric analysis. Med Oral Patol Oral Cir Bucal. 2012 Jul 1;17(4):e678-88. doi: 10.4317/medoral.17721.
- Background: PubMed 34943528Li C, Teixeira H, Tanna N, Zheng Z, Chen SHY, Zou M, Chung CH. The Reliability of Two- and Three-Dimensional Cephalometric Measurements: A CBCT Study. Diagnostics (Basel). 2021 Dec 7;11(12):2292. doi: 10.3390/diagnostics11122292.
- Background: PubMed 26561441Carter K, Worthington S. Predictors of Third Molar Impaction: A Systematic Review and Meta-analysis. J Dent Res. 2016 Mar;95(3):267-76. doi: 10.1177/0022034515615857. Epub 2015 Nov 11.
- Background: PubMed 37601239Bin Rubaia'an MA, Neyaz A, Talic F, Alkhamis A, Alghabban A, Assari A. The Association Between Skeletal Facial Types and Third Molars Impaction in a Saudi Arabian Subpopulation: A CBCT Study. Clin Cosmet Investig Dent. 2023 Aug 15;15:143-156. doi: 10.2147/CCIDE.S419325. eCollection 2023.
- Background: PubMed 12169031Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
- Background: PubMed 6950638Hagg U, Taranger J. Dental emergence stages and the pubertal growth spurt. Acta Odontol Scand. 1981;39(5):295-306. doi: 10.3109/00016358109162293.
- Individual participant dataSharing planned: Undecided
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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.
Bart VANDE VANNET, PhD study director
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Third Molar Tooth, run by Central Hospital, Nancy, France at 1 site in France.
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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart VANDE VANNET, PhD (+32496284339, bart.vande-vannet@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance between the occlusal plane and the second molar (time frame: One day). The study lists 2 primary outcomes in all. 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 NCT06320665, which also lists 17 linked publications.
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 28 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.