Assessment of Dental Pathologies Using Digital Tools

NCT07205588 | Recruiting

• 1 other identifier: RECOL 2024-01
• Study Type: observational
• Target: 350
• Locations: 2 countries
• Sites: 22

Brief Summary

Digital technology is playing an increasingly important role in dentistry, because of its ability to support the practitioner and increase work efficiency. Among digital tools, orthopantomogram (OPT or panoramic) radiography is currently the most widely used. It provides a global view of the jaws, highlighting internal structures in 2D. As in other fields, scientific advances have made it possible to go beyond the limited representation of two planes of space and obtain 3D images. The intraoral scanner (IOS) or "optical impression camera" appeared in the mid-80s. They use light to create a digital optical impression that reproduces the surface of external anatomical structures in 3D images. It improves dental practice, making impressions less uncomfortable for patients, saving clinical time, facilitating storage and archiving, and facilitating transmission to the prosthetist where appropriate. This type of device is already well established in dental practices. More recently, Cone Beam Computed Tomography (CBCT) has also begun to develop. This 3D sectional imaging technique adds an extra dimension to the exploration of internal structures. Imaging examinations provide additional information to that obtained from the visual clinical oral examination. Together, they help the practitioner to establish the diagnosis and treatment plan. Currently, visual information has to be collected manually. Collecting this data represents a significant amount of information. Its quality and completeness are crucial to the success of the treatment. Given the high volume of consultations, and practitioners' need to optimize their time, it would be interesting to assess whether optical impressions, at least in part, could help to acquire this clinical data more systematically and more rapidly, in order to improve patient management. Similarly, Cone Beam CT (CBCT), with its 3D data, improves the accuracy of diagnostic information. It would also be interesting to assess the real added value of this examination. The RESTODATA-NUM study follows on from the RESTODATA study, the results of which provided recent information on the oral status of adult patients, and their care needs. The aim of this study is to compare the performance of a standard real-life examination by the practitioner combining clinical and radiographic examinations (referred to here as practitioner-on-patient detection) on the one hand, and an examination based on imaging results obtained using digital tools on the other, in terms of detecting dental condition in a sample of adult patients consulting for an oral examination at one of the participating centers.

Conditions

Dental Caries (Diagnosis); Dental Plaque (Diagnosis); Periodontitis

Outcome Measures

Primary Outcomes (1)

• Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index

  Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index

  at the day of the dental examination

Secondary Outcomes (6)

• Location and extent of carious dental lesions

  At the day of the dental examination

• Location and extent of dental wear lesions

  At the day of the dental examination

• Location, extent, and quality of dental restorations across all detection methods:

  At the day of the dental examination

• Periodontal involvement

  At the day of the dental examination

• Endodontic status

  At the day of the dental examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be offered to all patients attending a participating investigation center for an oral examination who meet the study's inclusion criteria

You may qualify if:

• Patients who have read the information sheet and agreed to participate in the study
• Patients affiliated with a social security scheme
• Patients aged 18 years or older
• New patients to the practice or patients who have not visited the practice in the past six months

You may not qualify if:

• Patient who has expressed opposition to participating in the study
• Age \< 18 years
• Individual under legal guardianship or curatorship
• Pregnant woman
• Patient currently undergoing orthodontic treatment with fixed appliances

Sponsors & Collaborators

• Recherche Clinique en Odontologie (ReCOL): lead

Study Sites (22)

Cabinet dentaire Robbiani

Châtillon, 92320, France

RECRUITING

AP HP

Colombes, 92700, France

RECRUITING

Cabinet dentaire Ibn Attya Andaloussi

La Chapelle-sur-Erdre, 44200, France

RECRUITING

Cabinet dentaire Thiébaut

Landivisiau, 29400, France

RECRUITING

Cabinet dentaire Lemasson

Latresne, 33360, France

RECRUITING

Cabinet dentaire Pouchoulin

Les Côtes-d'Arey, 38138, France

RECRUITING

Cabinet dentaire Dougnac-Galant

Lyon, 69006, France

RECRUITING

AP HM

Marseille, 13005, France

RECRUITING

Cabinet dentaire Szerbojm

Ozoir-la-Ferrière, 77330, France

RECRUITING

Cabinet dentaire Martin

Paimpol, 22500, France

RECRUITING

Cabinet dentaire Drouhet

Paris, 75007, France

RECRUITING

Cabinet dentaire Huret

Paris, 75013, France

RECRUITING

Cabinet dentaire Labidi

Paris, 75014, France

RECRUITING

Cabinet dentaire Decup

Paris, 75017, France

RECRUITING

Cabinet dentaire Calvo

Quint-Fonsegrives, 31130, France

RECRUITING

CHU Reims

Reims, 51092, France

RECRUITING

CHU Rennes

Rennes, 35043, France

RECRUITING

Cabinet cabinet Perier

Saint-Marcellin-en-Forez, 42680, France

RECRUITING

Cabinet dentaire Guyon-Barras

Saint-Victor-de-Cessieu, 38110, France

RECRUITING

Cabinet dentaire Delacroix

Thorigné-Fouillard, 35235, France

RECRUITING

Cabinet dentaire Janisset-Masse

Villiers-sur-Marne, 94350, France

RECRUITING

Cabinet dentaire Enjary

La Saline, 97422, Reunion

RECRUITING

Related Publications (10)

• Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available.

  PMID: 3457698 BACKGROUND

• Van der Velden U. The Dutch periodontal screening index validation and its application in The Netherlands. J Clin Periodontol. 2009 Dec;36(12):1018-24. doi: 10.1111/j.1600-051X.2009.01495.x.

  PMID: 19929955 BACKGROUND

• Ainamo J, Barmes D, Beagrie G, Cutress T, Martin J, Sardo-Infirri J. Development of the World Health Organization (WHO) community periodontal index of treatment needs (CPITN). Int Dent J. 1982 Sep;32(3):281-91. No abstract available.

  PMID: 6958657 BACKGROUND

• O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.

  PMID: 4500182 BACKGROUND

• Bartlett D, Ganss C, Lussi A. Basic Erosive Wear Examination (BEWE): a new scoring system for scientific and clinical needs. Clin Oral Investig. 2008 Mar;12 Suppl 1(Suppl 1):S65-8. doi: 10.1007/s00784-007-0181-5. Epub 2008 Jan 29.

  PMID: 18228057 BACKGROUND

• Ismail AI, Pitts NB, Tellez M; Authors of International Caries Classification and Management System (ICCMS); Banerjee A, Deery C, Douglas G, Eggertsson H, Ekstrand K, Ellwood R, Gomez J, Jablonski-Momeni A, Kolker J, Longbottom C, Manton D, Martignon S, McGrady M, Rechmann P, Ricketts D, Sohn W, Thompson V, Twetman S, Weyant R, Wolff M, Zandona A. The International Caries Classification and Management System (ICCMS) An Example of a Caries Management Pathway. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. No abstract available.

  PMID: 26391116 BACKGROUND

• Decup F, Dantony E, Chevalier C, David A, Garyga V, Tohme M, Gueyffier F, Nony P, Maucort-Boulch D, Grosgogeat B. Needs for re-intervention on restored teeth in adults: a practice-based study. Clin Oral Investig. 2022 Jan;26(1):789-801. doi: 10.1007/s00784-021-04058-5. Epub 2021 Jul 24.

  PMID: 34302555 BACKGROUND

• Kaasalainen T, Ekholm M, Siiskonen T, Kortesniemi M. Dental cone beam CT: An updated review. Phys Med. 2021 Aug;88:193-217. doi: 10.1016/j.ejmp.2021.07.007. Epub 2021 Jul 17.

  PMID: 34284332 BACKGROUND

• Schmalzl J, Roth I, Borbely J, Hermann P, Vecsei B. The impact of software updates on accuracy of intraoral scanners. BMC Oral Health. 2023 Apr 15;23(1):219. doi: 10.1186/s12903-023-02926-y.

  PMID: 37061664 BACKGROUND

• Chi J. Digital Impressions and In-Office CAD/CAM: A Review of Best Practices and What's to Come. Compend Contin Educ Dent. 2021 Mar;42(3):140-141.

  PMID: 34010575 BACKGROUND

MeSH Terms

Conditions

Dental Caries; Disease; Dental Plaque; Periodontitis

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Periodontal Diseases; Mouth Diseases

Study Officials

• Brigitte Grosgogeat, DDS, PhD

  Service de Consultations et de Traitements Dentaires Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigitte Grosgogeat, DDS, PhD

CONTACT

+33 4 27 85 4023; brigitte.grosgogeat@univ-lyon1.fr

Franck Decup, DDS

CONTACT

000000000; franck.decup@orange.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: October 3, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21); RE (1)