NCT06320665

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

February 6, 2024

Last Update Submit

March 25, 2025

Conditions

Impacted Third Molar Tooth

Keywords

Cone beam ctthird molarVertical dimensionImpacted teethOrthodonticAdultSkeletal pattern

Outcome Measures

Primary Outcomes (2)

  • Distance between the occlusal plane and the second molar

    Depth of the third molar in mm

    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)

    One day

Study Arms (3)

Class I

Patient with class I occlusion, with at least one impacted third molar

Other: Radiographic measurement

Class II

Patients with class II malocclusion, with at least one impacted third molar

Other: Radiographic measurement

Class III

Patients with class III malocclusion, with at least one impacted third molar

Other: Radiographic measurement

Interventions

Radiographic measurementOTHER

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

Class IClass IIClass III

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

French adults with at least one impacted third molar

You may qualify if:

  • CMV stage 5 on lateral radiography (end of growth)
  • at least one impacted third molar at minimum Nolla stage 6 development

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'Orthopédie dento-faciale

Nancy, 54000, France

RECRUITING

Related Publications (17)

  • 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.

    PMID: 34025081BACKGROUND

  • 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.

    PMID: 23538430BACKGROUND

  • 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.

    PMID: 32589125BACKGROUND

  • 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.

    PMID: 30380552BACKGROUND

  • 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.

    PMID: 18486787BACKGROUND

  • 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.

    PMID: 35466682BACKGROUND

  • 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.

    PMID: 22322503BACKGROUND

  • 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.

    PMID: 34943528BACKGROUND

  • 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.

    PMID: 26561441BACKGROUND

  • 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.

    PMID: 37601239BACKGROUND

  • 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.

    PMID: 12169031BACKGROUND

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

    PMID: 6950638BACKGROUND

  • 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.

    PMID: 34188406BACKGROUND

  • 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.

    PMID: 12166710BACKGROUND

  • 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.

    PMID: 34205078BACKGROUND

  • 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.

    PMID: 23229243BACKGROUND

  • 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.

    PMID: 30427496BACKGROUND

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Bart VANDE VANNET, PhD

    Central Hospital, Nancy, France

    STUDY DIRECTOR

Central Study Contacts

Bart VANDE VANNET, PhD

CONTACT

+32496284339bart.vande-vannet@univ-lorraine.fr

Mathilde LAE

CONTACT

+33781893850mathildelae@hotmail.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2024

First Posted

March 20, 2024

Study Start

December 1, 2024

Primary Completion

July 30, 2025

Study Completion

September 30, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

FR(1)