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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06320665
Other study ID # 2024PI003
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date September 30, 2025

Study information

Verified date April 2024
Source Central Hospital, Nancy, France
Contact Bart VANDE VANNET, PhD
Phone +32496284339
Email bart.vande-vannet@univ-lorraine.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date September 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - CMV stage 5 on lateral radiography (end of growth) - at least one impacted third molar at minimum Nolla stage 6 development Exclusion Criteria: - Previous maxillofacial trauma - Growing patients - Missing permanent tooth or early avulsion - Dysplasia - Dentofacial deformities - Endocrinological pathologies with implications for maxillofacial growth - Syndromes - History of maxillofacial or orthognathic surgery - History of orthodontic treatment - Incomplete data

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Radiographic measurement
Measurements taken on 3D radiographs, to assess third molar inclusion and skeletal typology (vertical and sagittal)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

References & Publications (17)

Ahmed M, Shaikh A, Fida M. Diagnostic validity of different cephalometric analyses for assessment of the sagittal skeletal pattern. Dental Press J Orthod. 2018 Sep-Oct;23(5):75-81. doi: 10.1590/2177-6709.23.5.075-081.oar. — View Citation

Aoun 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. — View Citation

Baccetti 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. — View Citation

Bin 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. — View Citation

Carter 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. — View Citation

Costa 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. — View Citation

Hagg U, Taranger J. Dental emergence stages and the pubertal growth spurt. Acta Odontol Scand. 1981;39(5):295-306. doi: 10.3109/00016358109162293. — View Citation

Hasan 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. — View Citation

Hashemipour MA, Tahmasbi-Arashlow M, Fahimi-Hanzaei F. Incidence of impacted mandibular and maxillary third molars: a radiographic study in a Southeast Iran population. Med Oral Patol Oral Cir Bucal. 2013 Jan 1;18(1):e140-5. doi: 10.4317/medoral.18028. — View Citation

Hounsome 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. — View Citation

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. — View Citation

Jaron 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. — View Citation

Legovic 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. — View Citation

Li 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. — View Citation

Mollaoglu 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. — View Citation

Tassoker 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. — View Citation

Zamora 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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Distance between the occlusal plane and the second molar Depth of the third molar in mm One day
Primary 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) One day
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