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Dental Caries (Diagnosis)RESTODATA-NUMNCT07205588

Assessment of Dental Pathologies Using Digital Tools

An observational study of Dental Caries (Diagnosis) and Dental Plaque (Diagnosis), run by Recherche Clinique en Odontologie (ReCOL) at 22 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
350 participants
Where
22 sitesin 2 countries
Study dates
4 Feb 2025to 31 Dec 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Brigitte Grosgogeat, DDS, PhD contact

+33 4 27 85 4023

brigitte.grosgogeat@univ-lyon1.fr

Franck Decup, DDS contact

000000000

franck.decup@orange.fr

22 sites in 2 countries

France21 sites, 21 recruiting

  • Cabinet dentaire Robbiani

    Châtillon, 92320

    Eric Robbiani, DDS, 00000000000, eric@robbiani.fr

    Eric Robbiani, DDS

    Recruiting

  • AP HP

    Colombes, 92700

    Anne-Margaux Collignon, DDS, 00000000000, anne-margaux.collignon@aphp.fr

    Anne-Margaux Collignon, DDS

    Recruiting

  • Cabinet dentaire Ibn Attya Andaloussi

    La Chapelle-sur-Erdre, 44200

    Zakariae Ibn Attya Andaloussi, DDS, 00000000000, zakariae.ibnattya.3@gmail.com

    Zakariae Ibn Attya Andaloussi, DDS

    Recruiting

  • Cabinet dentaire Thiébaut

    Landivisiau, 29400

    Émilie Thiébaut, DDS, 00000000000, drthiebaut.e@gmail.com

    Émilie Thiébaut, DDS

    Recruiting

  • Cabinet dentaire Lemasson

    Latresne, 33360

    François Lemasson, DDS, 00000000000, dr.lemasson.francois@hotmail.fr

    François Lemasson, DDS

    Recruiting

  • Cabinet dentaire Pouchoulin

    Les Côtes-d'Arey, 38138

    Anne Laure Pouchoulin, DDS, 00000000000, anne-laurepouch@hotmail.fr

    Anne Laure Pouchoulin, DDS

    Recruiting

  • Cabinet dentaire Dougnac-Galant

    Lyon, 69006

    Thomas Dougnac-Galant, DDS, 00000000000, thomas@dougnac.fr

    Thomas Dougnac-Galant, DDS

    Recruiting

  • AP HM

    Marseille, 13005

    Virginie Pilliol, DDS, 00000000000, virginie.pilliol@ap-hm.fr

    Virginie Pilliol, DDS

    Recruiting

  • Cabinet dentaire Szerbojm

    Ozoir-la-Ferrière, 77330

    Sophie Szerbojm, DDS, 00000000000, so.sz@orange.fr

    Sophie Szerbojm, DDS

    Recruiting

  • Cabinet dentaire Martin

    Paimpol, 22500

    Linda Martin, DDS, 00000000000, lindamartin3010@gmail.com

    Linda Martin, DDS

    Recruiting

  • Cabinet dentaire Drouhet

    Paris, 75007

    Thibault Drouhet, DDS, 00000000000, thibault.drouhet@gmail.com

    Thibault Drouhet, DDS

    Recruiting

  • Cabinet dentaire Huret

    Paris, 75013

    Stéphanie Huret, DDS, 00000000000, stephanie.huret@gmail.com

    Stéphanie Huret, DDS

    Recruiting

  • Cabinet dentaire Labidi

    Paris, 75014

    Farida Labidi, DDS, 00000000000, labidi.n@orange.fr

    Farida Labidi, DDS

    Recruiting

  • Cabinet dentaire Decup

    Paris, 75017

    Franck Decup, DDS, 00000000000, franck.decup@orange.fr

    Franck Decup, DDS

    Recruiting

  • Cabinet dentaire Calvo

    Quint-Fonsegrives, 31130

    Loïc Calvo, DDS, 00000000000, dr.calvoloic@orange.fr

    Loïc Calvo, DDS

    Recruiting

  • CHU Reims

    Reims, 51092

    Christina Maillet, DDS, 00000000000, christina.maillet@univ-reims.fr

    Christina Maillet, DDS

    Recruiting

  • CHU Rennes

    Rennes, 35043

    Etienne Lefrançois, DDS, 00000000000, etienne.lefrancois@univ-rennes.fr

    Etienne Lefrançois, DDS

    Recruiting

  • Cabinet cabinet Perier

    Saint-Marcellin-en-Forez, 42680

    Nicolas Perier, DDS, 00000000000, dr.perier.nicolas@gmail.com

    Nicolas Perier, DDS

    Recruiting

  • Cabinet dentaire Guyon-Barras

    Saint-Victor-de-Cessieu, 38110

    Marie Guyon-Barras, DDS, 00000000000, drbarras.marie@gmail.com

    Marie Guyon-Barras, DDS

    Recruiting

  • Cabinet dentaire Delacroix

    Thorigné-Fouillard, 35235

    Hugo Delacroix, DDS, 00000000000, delacroix.hugo@orange.fr

    Hugo Delacroix, DDS

    Recruiting

  • Cabinet dentaire Janisset-Masse

    Villiers-sur-Marne, 94350

    Nathalie Janisset-Masse, DDS, 00000000000, n.janissetmasse@gmail.com

    Nathalie Janisset-Masse, DDS

    Recruiting

Other trials in France

Reunion1 site, 1 recruiting

  • Cabinet dentaire Enjary

    La Saline, 97422

    Céline Enjary, DDS, 00000000000, celineen@gmail.com

    Céline Enjary, DDS

    Recruiting

Other trials in Reunion

About this study

Official title: RESTODATA-NUM: A Multicenter Observational Study on the Assessment of Dental Pathologies Using Digital Tools in Adults

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.

Read more

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.

Read the detailed description

Digital technology is playing an increasingly important role in dentistry due to its ability to assist practitioners and enhance work efficiency.

Among digital tools, panoramic radiography (orthopantomogram) is currently the most widely used. It provides a comprehensive image of the jaws, highlighting internal structures in 2D. As in other fields, scientific advances have made it possible to go beyond two-dimensional representations and obtain 3D images.

The intraoral scanner, also known as an "optical impression camera," emerged in the mid-1980s. These devices use light to create a digital optical impression that reproduces the surface of external anatomical structures in 3D images. They improve dental practice by making impression-taking less uncomfortable for patients, saving clinical time, simplifying storage and archiving, and facilitating transmission to dental technicians when needed. This type of device is already well established in dental practices.

More recently, Cone Beam Computed Tomography (CBCT), also known as digital volumetric tomography with a conical beam, has begun to develop. This 3D sectional imaging technique allows for the exploration of internal structures by adding an extra dimension.

Imaging examinations provide additional information that complements the findings of the visual clinical oral examination. Together, they help the practitioner establish a diagnosis and treatment plan. Currently, visual information must be recorded manually. Collecting this data represents a significant amount of information, and the success of treatment partly depends on its quality and completeness.

Given the high volume of consultations and the need for practitioners to optimize their time, it would be worthwhile to assess whether optical impressions could help systematically and quickly acquire some of this clinical data to improve patient care.

Similarly, the 3D data provided by CBCT enhances the accuracy of diagnostic information. It would also be useful to evaluate the actual added value of this examination.

The RESTODATA-NUM study follows on from the RESTODATA study, whose results provided recent insights into the oral health status and care needs of adult patients.

The objective of this study is to compare the performance of a standard real-life examination by a practitioner-combining clinical and radiographic assessments-with an examination based on imaging results obtained using digital tools, in terms of detecting dental conditions in a sample of adult patients undergoing an oral examination at one of the participating centers.

Information on the Type of Clinical Investigation:

This is an observational, descriptive, and multicenter study. Based on these characteristics, the study is initially classified by the principal investigator as a Category 3 research project under the Jardé Law (Article R1121-3 of the French Public Health Code, Decree No. 2006-477 of April 26, 2006). The digital tools used in this study (intraoral scanner, panoramic radiography, and cone beam computed tomography) are routinely employed in dental practices. Radiographs will only be performed when medically justified. There will be no deviation from standard patient care, and no additional procedures will be introduced.

Overview of the ReCOL Network and Participating Private Practices:

The ReCOL network is a French clinical research network in dentistry, inspired by a similar model in the United States. Its goal is to involve private dental practitioners in clinical studies. Established in 2018, ReCOL has already conducted several studies, many of which are available on its website: https://recol.fr. The network operates collaboratively, with research topics discussed within the association's executive board. The idea for the RESTODATA-NUM study emerged from one of these discussions.

A total of 36 dental surgeons, all equipped with the necessary tools for the study, responded positively to a call for participation sent via email to all ReCOL members. Some of these practitioners had previously participated in the RESTODATA study.

Study Procedure and Data Collection:

Each participant will attend a single study visit.

Eligibility will be assessed by the investigating dental surgeon. The study will be offered to all patients attending a participating center for an oral examination who meet the inclusion criteria.

An information letter will be provided to each patient. If no urgent care is required, patients may take up to seven days to consider participation and reschedule their appointment if desired. Upon agreement, the patient will sign a non-opposition form.

Medical subject headings
Dental Caries, Disease, Dental Plaque, Periodontitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at the day of the dental examination

Secondary outcomes (6)

  1. Location and extent of carious dental lesions

    Location and extent of carious dental lesions:

    Assessed clinically and from intraoral scan (IOS) images using the simplified International Caries Detection and Assessment System, version 6 (ICDAS-6) score, using a scale from 0 to 6. Higher scores indicate worse outcomes, reflecting increasing severity of carious lesions.

    Assessed radiographically on panoramic radiographs (OPT) or cone beam CT (CBCT) using a three-level radiographic scale of carious involvement (enamel, initial dentin, deep dentin)"

    Measured: At the day of the dental examination

  2. Location and extent of dental wear lesions

    Location and extent of dental wear lesions:

    Assessed clinically and from intraoral scan (IOS) images using the BEWE score Assessed radiographically using a three-level scale of dental tissue thickness reduction (enamel thinning, complete enamel surface loss, enamel surface loss with dentin exposure)

    Measured: At the day of the dental examination

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

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

    Assessed based on their type, the number of involved surfaces, and their location (using CCAM coding) Assessed using a three-level index: adequate, minor but acceptable defects (to be monitored), major or harmful defects (requiring repair or replacement)

    Measured: At the day of the dental examination

  4. Periodontal involvement

    Periodontal involvement (gingival inflammation, presence of calculus, pockets, recession):

    Clinically assessed using the Plaque Index Clinically assessed using the CPITN and DPSI indices Assessed from intraoral scan (IOS) images using a 4-level visual index: healthy, inflammation, inflammation with calculus, inflammation with calculus and recession Radiographically assessed based on the location and severity of bone loss visible on panoramic radiographs (OPT) or cone beam CT (CBCT)

    Measured: At the day of the dental examination

  5. Endodontic status

    Endodontic status: number and location of teeth with pulpal involvement and periapical complications, detected and assessed radiographically on panoramic radiographs (OPT) or cone beam CT (CBCT):

    Periapical lesion evaluated using the simplified Periapical Index (PAI)

    Measured: At the day of the dental examination

  6. Endodontic status

    Endodontic status: number and location of teeth with pulpal involvement and periapical complications, detected and assessed radiographically on panoramic radiographs (OPT) or cone beam CT (CBCT):

    Presence of root canal treatment (CCAM code)

    Measured: At the day of the dental examination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start4 Feb 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Cross-sectional
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205588
Sponsor's protocol ID
RECOL 2024-01
Acronym
RESTODATA-NUM
Status last verified
Sep 2025
First submitted
17 Jul 2025
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • 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.

    PubMed 3457698

  • 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.

    PubMed 19929955

  • 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.

    PubMed 6958657

  • 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.

    PubMed 4500182

  • 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.

    PubMed 18228057

  • 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.

    PubMed 26391116

  • 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.

    PubMed 34302555

  • 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.

    PubMed 34284332

  • 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.

    PubMed 37061664

  • 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.

    PubMed 34010575

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Caries (Diagnosis) and Dental Plaque (Diagnosis), run by Recherche Clinique en Odontologie (ReCOL) at 22 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 4 inclusion and 5 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in France, Reunion. 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 Brigitte Grosgogeat, DDS, PhD (+33 4 27 85 4023, brigitte.grosgogeat@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Decayed, Missing, or Filled Teeth in the permanent dentition, measured both clinically and from intraoral scan (IOS) images using the DMFT index (time frame: at the day of the dental examination). 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 NCT07205588, which also lists 10 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 3 Oct 2025.

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