History of at Least One Coronal Dental RestorationRESTO DATANCT03854526
Evaluation of Dental Coronal Restorations
An observational study of History of at Least One Coronal Dental Restoration, run by Hospices Civils de Lyon at 61 sites in France.
Trial summary
The purpose of this study is to provide the latest information on the oral health status of patients, the lifetime of restorations, to quantify the incidence of defects rates on inserted restorations in conservative dentistry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- History of at Least One Coronal Dental Restoration
- What is being tested?
- Evaluation of the quality of direct and indirect partial dental coronal restorations in adults
- Type of treatment
- Pill or oral medicine
- How many people
- 863 participants
- Where
- 61 sitesFrance
- Study dates
- 28 Mar 2019to 23 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: adults with at least one dental restoration and consultant for the first time since at least six months in a private practice, or at hospital, in a classical odontological service or a consultation specializing in Gougerot Sjogren disease.
Who may be able to join
- Patient having read and signed the information letter attesting to his/her non-opposition
- Affiliated to a social security scheme
- Patient over 18 years old
- New patient in the practice or in the hospital service, that can be a classical odontalogical service or a consultation specializing in Gougerot Sjogren disease, with no history of a dental examination less than six months old, or Patient who has not consulted in the last six months
- Patient with at least one tooth with partial coronal restoration
Who cannot join
- Patient under tutorship or curatorship
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
France61 sites
CHU de Bordeaux, Hôpital Xavier Arnozan, Unité de médecine bucco-dentaire
Bordeaux, 33604
Isabelle GIRSCHIG-ALLE
Boulogne, 92100
CHRU de Brest, Service Odontologie consultation spécialisée
Brest, 29200
CHRU de Brest, Service Odontologie
Brest, 29200
Stéphanie MIFSUD
Brindas, 69126
Laurianne DUDOUIT
Caluire-et-Cuire, 69300
Jean-Bruno LAFRASSE
Chambéry, 73000
Eric ROBBIANI
Châtillon, 92320
CHU Estaing, Service d'Odontologie
Clermont-Ferrand, 63003
APHP Hôpital Louis Mourier
Colombes, 92700
APHP, Hopital Henri Mondor, Service de Médecine Bucco-Dentaire
Créteil, 94000
Selma OULADDIAF
Créteil, 94000
Justine LOSSI
Décines-Charpieu, 69150
Nicolas KAPRIELIAN
Décines-Charpieu, 69150
Jérôme PIEAUD
Échirolles, 38130
Laura COHEN BOULAKIA
Échirolles, 38130
Alix SAUVAGNAC
Garches, 92380
François-Marie DUTOUR
Issoire, 63500
APHP Hôpital Charles Foix, Service Odontologie consultation spécialisée
Ivry-sur-Seine, 94200
APHP Hôpital Charles Foix, Service Odontologie
Ivry-sur-Seine, 94200
Camille TOURNADRE
La Fouillouse, 42480
Aurélie TRUFFINET
Le Mesnil-Saint-Denis, 78320
CHU Lille, Service d'Odontologie
Lille, 59000
Valentin GARYGA
Lyon, 69001
Marie-Anne MY
Lyon, 69003
Stéphanie GAUTHEROT
Lyon, 69003
Alexandra DAVID
Lyon, 69006
Arnaud JANIN
Lyon, 69006
Hospices Civils de Lyon, Service d'Odontologie
Lyon, 69007
Philippe GERENTES
Lyon, 69007
Jérémie DECHAUX
Montalieu, 38390
Claire FRANCHI
Neuilly-sur-Seine, 92200
Solène MARNIQUET
Neuilly-sur-Seine, 92200
CHU, Service d'Odontologie
Nice, 06000
Céline VINTER
Paris, 75002
Valérie AMZALLAG GUIDONI
Paris, 75004
Jonathan CHESNEAU
Paris, 75006
Anne Claire LOISEAU
Paris, 75007
Thibault DROUHET
Paris, 75007
AP-HP, Hopital Rothschlid
Paris, 75012
Aurélia GUERRIERI
Paris, 75013
Florent TREVELO
Paris, 75013
Christian MOUSSALLY
Paris, 75015
Anthony ATLAN
Paris, 75017
Franck DECUP
Paris, 75017
Magali RENEAU
Paris, 75017
Maxime DROSSART
Paris, 75017
Catherine MESGOUEZ-MENEZ
Paris, 75116
CHU de Reims, Pôle de Médecine Bucco-Dentaire
Reims, 51100
CHU, Centre de soins Dentaires
Rennes, 35033
Florian POCHELU
Roanne, 42300
Nathalie DELARGE DIONIS
Rueil-Malmaison, 92500
Gaëlle CHOMETTE
Saint-Just-Saint-Rambert, 42170
Nicolas PERIER
Saint-Marcellin-en-Forez, 42680
Jacques TIXIER
Solaize, 69360
CHU de Toulouse, Service d'Odontologie
Toulouse, 31400
Laure DECHELETTE
Versailles, 78000
Anaïs CHABANNE
Vienne, 38200
Harmik MINASSIAN
Villefranche-sur-Saône, 69400
Xavier BONDIL
Villefranche-sur-Saône, 69400
Nathalie JANISSET-MASSE
Villiers-sur-Marne, 94350
About this study
Official title: Evaluation of Direct and Indirect Partial Dental Coronal Restorations Within a Dental Practice-based Research Network and a Set of Hospital-university Odontology Services
The purpose of this study is to provide the latest information on the oral health status of patients, the lifetime of restorations, to quantify the incidence of defects rates on inserted restorations in conservative dentistry. Moreover, the study permits to compare needs of two different patient populations depending on the place of consultation (those consulting in hospital services and those consulting in private structures) and to compare the quality of coronary fillings in patients with of Gougerot Sjogren disease and those not affected.
A minimum sample of 840 adult subjects consecutively seen at the investigator's office over a period of 33 months is expected ; 400 subjects included in private structures and 440 subjected included in university hospital services (8 to 15 patients per investigator), including at least 40 patients with Gougerot Sjogren disease (disease prevalence = 0.1%).
The investigators of these study are 46 dentists working in private dental practices or private structures of dental care spread over the " Ile-de-France " and " Rhône-Alpes Auvergne " régions and 43 dentists working in 13 french university hospital services in odontology, including two hosting one consultation for Gougerot Sjogren disease, from the ReCOL network (Recherche Clinique en Odontologie Libérale).
- Being tested
- Evaluation of the quality of direct and indirect partial dental coronal restorations in adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the quality of direct and indirect partial dental coronal restorations in adultsOther
The medical and dental anamnesis are registered. In addition to the medical history questionnaire, the patient completes the self-assessment questionnaire on oral health. Then, a complete and intra-oral clinical examination is performed. The collection of clinical data is done on the dentist's chair. All data are included in the e-CRF.
All radiographic procedures will be performed according to national guidelines. If the investigator deems it clinically necessary, a panoramic X-ray will be taken and stored in the patient's HER system. Periapical radiographs (using a parallelogram technique with a radiographic film holder) will be taken for teeth with periapical radiolucency on panoramic X-ray, or with defective coronal restoration, or when the clinician needs more information for diagnosis or planning.
| Study group | Role | What they receive |
|---|---|---|
| Patients without Gougerot Sjogren disease | New patient, or patient, with no history of a dental examination in the last six months and with at least one tooth with coronal dental restoration Receives: Other: Evaluation of the quality of direct and indirect partial dental coronal restorations in adults | |
| Patients with Gougerot Sjogren disease | New patient, or patient, with no history of a dental examination in the last six months, with at least one tooth with coronal dental restoration and presenting a Gougerot Sjogren disease Receives: Other: Evaluation of the quality of direct and indirect partial dental coronal restorations in adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of coronary obturation with a simplified notation a, b or c
notation is based on FDI (World Dental Federation) criteria
Measured: At day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start28 Mar 2019
- Primary completion23 Dec 2021
- Study completion23 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for History of at Least One Coronal Dental RestorationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 863 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte GROSGOGEAT, Professor, Study director, Hospices Civils de LyonFranck DECUP, Associate Professor, Study director, Assistance Publique des Hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854526
- Sponsor's protocol ID
- 69HCL18_0759
- Acronym
- RESTO DATA
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Direct and Indirect Partial Dental Coronal Restorations Within a Dental Practice-based Research Network and a Set of Hospital-university Odontology Services
- ClinicalTrials.gov ID
- NCT03854526
- Acronym / sponsor ID
- RESTO DATA / 69HCL18_0759
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 863 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 23 Dec 2021 (actual)
- Study completion
- 23 Dec 2021 (actual)
- First posted
- 26 Feb 2019 (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 purpose of this study is to provide the latest information on the oral health status of patients, the lifetime of restorations, to quantify the incidence of defects rates on inserted restorations in conservative dentistry. Moreover, the study permits to compare needs of two different patient populations depending on the place of consultation (those consulting in hospital services and those consulting in private structures) and to compare the quality of coronary fillings in patients with of Gougerot Sjogren disease and those not affected.
A minimum sample of 840 adult subjects consecutively seen at the investigator's office over a period of 33 months is expected ; 400 subjects included in private structures and 440 subjected included in university hospital services (8 to 15 patients per investigator), including at least 40 patients with Gougerot Sjogren disease (disease prevalence = 0.1%).
The investigators of these study are 46 dentists working in private dental practices or private structures of dental care spread over the " Ile-de-France " and " Rhône-Alpes Auvergne " régions and 43 dentists working in 13 french university hospital services in odontology, including two hosting one consultation for Gougerot Sjogren disease, from the ReCOL network (Recherche Clinique en Odontologie Libérale).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without Gougerot Sjogren disease | – | Other: Evaluation of the quality of direct and indirect partial dental coronal restorations in adultsNew patient, or patient, with no history of a dental examination in the last six months and with at least one tooth with coronal dental restoration |
| Patients with Gougerot Sjogren disease | – | Other: Evaluation of the quality of direct and indirect partial dental coronal restorations in adultsNew patient, or patient, with no history of a dental examination in the last six months, with at least one tooth with coronal dental restoration and presenting a Gougerot Sjogren disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults with at least one dental restoration and consultant for the first time since at least six months in a private practice, or at hospital, in a classical odontological service or a consultation specializing in Gougerot Sjogren disease.
Key inclusion criteria (5 listed)
- Patient having read and signed the information letter attesting to his/her non-opposition
- Affiliated to a social security scheme
- Patient over 18 years old
- New patient in the practice or in the hospital service, that can be a classical odontalogical service or a consultation specializing in Gougerot Sjogren disease, with no history of a dental examination less than six months old, or Patient who has not consulted in the last six months
- Patient with at least one tooth with partial coronal restoration
Key exclusion criteria (1 listed)
- Patient under tutorship or curatorship
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 |
|---|---|---|
| Evaluation of the quality of direct and indirect partial dental coronal restorations in adultsThe medical and dental anamnesis are registered. In addition to the medical history questionnaire, the patient completes the self-assessment questionnaire on oral health. Then, a complete and intra-oral clinical examination is performed. The collection of clinical data is done on the dentist's chair. All data are included in the e-CRF. All radiographic procedures will be performed according to national guidelines. If the investigator deems it clinically necessary, a panoramic X-ray will be taken and stored in the patient's HER system. Periapical radiographs (using a parallelogram technique with a radiographic film holder) will be taken for teeth with periapical radiolucency on panoramic X-ray, or with defective coronal restoration, or when the clinician needs more information for diagnosis or planning. | Other | Patients with Gougerot Sjogren disease, Patients without Gougerot Sjogren disease |
Primary outcome
Status of coronary obturation with a simplified notation a, b or c
Time frame: At day 0
notation is based on FDI (World Dental Federation) criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Brigitte GROSGOGEAT, Professor study director
Hospices Civils de Lyon
Franck DECUP, Associate Professor study director
Assistance Publique des Hopitaux de Paris
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of History of at Least One Coronal Dental Restoration, run by Hospices Civils de Lyon at 61 sites 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of coronary obturation with a simplified notation a, b or c (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2022.