Back to resultsMulticenter Trial Comparing One-step Partial Caries Removal to Complete Caries Removal for the Treatment of Deep Carious Lesions in Permanent Teeth. (DECAT : DEep CAries Treatment). (DECAT)
Primary Purpose
Deep Caries
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.
A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.
The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).
The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)
Sponsored by
About this trial
This is an interventional treatment trial for Deep Caries focused on measuring Deep carious lesion, incomplete caries removal, antibacterial adhesive system, dental composite resin, pulp vitality preservation, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
- Patient consulting in one of the multicenter trial centers
- Male and female aged 8-80 (inclusive),
- Affiliated to a social security regimen
- Able to tolerate necessary restorative procedures
- Provide informed consent
- Accepts the three-year follow-up period
Tooth related criteria:
- Mature permanent posterior tooth
- Tooth with vital pulp according to pulp-sensitivity tests
- Tooth with a deep (primary or secondary) at least proximal and/or occlusal carious lesion presenting a residual dentin thickness with no continuity between the carious cavity and the pulp chamber.
- In case of proximal lesions, the proximal cervical limit must allow proper placement of a waterproof dental dam (confirmed by a bitewing X-ray radiograph)
- Tooth requiring a direct partial restorative treatment.
Randomization n°2 - Antibacterial vs. non antibacterial adhesive application
Tooth has been assigned a treatment by randomization n°1.
Exclusion Criteria:
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
- Person under guardianship, pregnant or nursing woman,
- Risk of infectious endocarditis,
- Patient who has an implanted Cardiac Pacemaker/Defibrillator
- Patient with severe periodontal disease (pocket depth ≥5mm and/or mobility type IV),
- Poor oral hygiene (abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin = score 3 [Silness and Loe, 1964],
- Allergy to any of the materials and/or anaesthetic used,
- Uncooperative patients.
Tooth related criteria:
- Nocturnal pain causing insomnia,
- Tooth suffering dentin hypersensitivity (sharp sudden pain of short duration pain arising from exposed dentin (erosion and/or gingival recession), typically in response to external stimuli (air blast hypersensitivity [Schiff et al., 1994], tactile hypersensitivity),
- Sensitivity to axial or lateral percussion;
- Radiolucent apical image,
- Condensing osteitis,
- Tooth having an external or internal resorption,
- Tooth having suffered trauma,
- Tooth with a carious cervical lesion,
- Tooth with an occlusal wear associated to a dentine exposure,
- Tooth supporting clasp of a removable partial denture (RPD).
- Tooth with defects of mineralization that once the treated tooth could come into contact of the carried out restoration
Randomization n°2 - Antibacterial vs. non antibacterial adhesive application
- Tooth with pulp exposure after randomization n°1 requiring endodontic treatment (pulp exposure > 2 mm² and/or haemostasis not obtained).
Sites / Locations
- Hôpital EstaingRecruiting
- Hôpital Albert ChenevierRecruiting
- Cabinet LibéralRecruiting
- Hôpital Charles FoixRecruiting
- CHU LilleRecruiting
- Service de consultations et traitements dentairesRecruiting
- Hôpital de la TimoneRecruiting
- CHRU de NantesRecruiting
- CHU NiceRecruiting
- APAH Rothschild- GarancièreRecruiting
- Groupe Hospitalier Pitié SalpétrièreRecruiting
- Cabinet LibéralRecruiting
- Hopital Xavier ArnozanRecruiting
- CHRU RennesRecruiting
- CHRU ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Partial excavation
Complete excavation
Antibacterial dental adhesive
Conventional dental adhesive
Arm Description
patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
Outcomes
Primary Outcome Measures
Probability of success in arm P (Partial Caries Removal) compared to arm C (Complete Caries Removal) using a composite criteria of success summarized as a binary success criteria (cf. description below)
Cases will be considered as successful if each of the 5 following criteria described by the World Dental Federation (FDI) present a score of 3 or less:
Fracture of material and retention (item 5)
Marginal adaptation (item 6)
Radiographic examination (including apical pathologies) (item 9)
Post-operative sensitivity and tooth vitality (item 11)
Recurrence of caries (item 12) Criteria 5, 6 and 9 are functional criteria while criteria 11 and 12 are biological criteria.
Considering a score of 4 or 5 as failure means that a re-intervention on the tooth (score 4) would be considered as a failure in the context of this study.
Adverse events will be recorded and reported as general safety outcomes.
Secondary Outcome Measures
Contribution of the functional and biological dimensions of the five FDI criteria items
Assessment of the relative importance of each of the 5 FDI criteria in determining failure for both the primary outcome
Probability of success in arm P (Partial Caries Removal) compared to arm C (Complete Caries Removal) using a composite criteria of success summarized as a binary success criteria, at two and three years of follow-up.
same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Probability of success after the use of an antibacterial adhesive compared to the use of a non-antibacterial adhesive using a composite criteria of success summarized as a binary success criteria, at one, two and three years of follow-up.
same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Identification of predictive factors of clinical success from among the following list: presence of post-operative pain, age of patient, type of the carious lesion, location of the carious lesion (occlusal or proximal) and pulp exposure.
the dependent variable (clinical success) corresponds to the same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Description of the Consequences of Failures per Treatment Arm
total number of visits, need for endodontic treatment, need for extraction
Full Information
NCT ID
NCT02286388
First Posted
October 15, 2014
Last Updated
September 28, 2016
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02286388
Brief Title
Multicenter Trial Comparing One-step Partial Caries Removal to Complete Caries Removal for the Treatment of Deep Carious Lesions in Permanent Teeth. (DECAT : DEep CAries Treatment).
Acronym
DECAT
Official Title
Multicenter Randomized Controlled Trial Comparing One-step Partial Caries Removal to Complete Caries Removal for the Treatment of Deep Carious Lesions in Permanent Teeth DECAT DEep CAries Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial is a national multicenter randomized controlled trial performed in parallel groups aiming to validate a treatment that preserves pulp vitality of mature permanent posterior teeth through partial removal of carious tissue and restoring tooth structure using a simple filling in one session, thus delaying premature tooth aging.
Two successive randomizations will be performed (allocation ratio 1:1); firstly for the type of excavation carried out (partial vs. complete caries removal) and secondly for the nature of the adhesive used (antibacterial adhesive vs. non-antibacterial adhesive). The second randomization will not be carried out for teeth requiring endodontic treatment after the first randomization.
The study's primary objective will be to compare, at 1 year of follow-up, the efficacy (binary success criteria) of partial caries removal versus complete caries removal in occlusal or proximal deep lesions of mature permanent posterior teeth (bicuspids and molars except third molars). Secondary objectives will include the comparison, at 1 year of follow-up, of the efficacy (binary success criteria) of an antibacterial two-step self-etch adhesive versus a traditional non-antibacterial two-step self-etch adhesive. Another secondary objective will be to compare, at two and three years of follow-up, the efficacy of partial versus complete caries removal.
The primary outcome is the success of the caries removal protocol at one year, measured according to 5 FDI criteria, while the secondary outcome is the contribution of the functional and biological dimensions of the 5 FDI criteria items to determining success or failure of the treatment. The outcome of success will be the same for all objectives, primary and secondary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Caries
Keywords
Deep carious lesion, incomplete caries removal, antibacterial adhesive system, dental composite resin, pulp vitality preservation, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
464 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Partial excavation
Arm Type
Experimental
Arm Description
patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
Arm Title
Complete excavation
Arm Type
Active Comparator
Arm Description
patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
Arm Title
Antibacterial dental adhesive
Arm Type
Experimental
Arm Description
patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
Arm Title
Conventional dental adhesive
Arm Type
Active Comparator
Arm Description
patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
Intervention Type
Procedure
Intervention Name(s)
A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.
Intervention Description
Instruments and procedures:
Soprolife® (Acteon, La Ciotat, France) dental imaging device to detect dentinal infection status. The green-black light indicates infected dentin, red indicates infected/affected dentin and green indicates healthy dentinal tissue.
Sterile round bur under water spray coolant followed by final excavation with hand instruments The clinician will remove the superficial necrotic and demineralized dentin with complete excavation of the peripheral demineralized dentin, avoiding excavation close to the pulp.
Hand instruments will be used for final excavation following clinical criteria guidelines (color of residual dentin and probe resistance) and taking in to consideration the color data obtained by the Soprolife® camera.
The operator will stop excavating when the dentin close to the pulp appears red (for infected dentin).
Intervention Type
Procedure
Intervention Name(s)
A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.
Intervention Description
Instruments and procedures:
Idem partial excavation arm.
In the complete excavation arm, the operator will stop excavating when the dentin close to the pulp appears green (for healthy dentin tissue) using the Soprolife® camera, leaving no infected or affected dentin.
Intervention Type
Device
Intervention Name(s)
The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).
Intervention Description
Enamel and dentin will be conditioned according to the manufacturer's instructions. Both antibacterial and conventional adhesives are two-steps bonding systems.
The first step consists of the application of a primer to the enamel and dentin for 20 seconds (which allows the completion of etching and priming procedures). The second step consists of the application of the antibacterial adhesive and its light curing for 10 seconds.
Intervention Type
Device
Intervention Name(s)
The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)
Intervention Description
Idem antibacterial dental adhesive arm. A conventional dental adhesive will be used instead of an antibacterial.
Primary Outcome Measure Information:
Title
Probability of success in arm P (Partial Caries Removal) compared to arm C (Complete Caries Removal) using a composite criteria of success summarized as a binary success criteria (cf. description below)
Description
Cases will be considered as successful if each of the 5 following criteria described by the World Dental Federation (FDI) present a score of 3 or less:
Fracture of material and retention (item 5)
Marginal adaptation (item 6)
Radiographic examination (including apical pathologies) (item 9)
Post-operative sensitivity and tooth vitality (item 11)
Recurrence of caries (item 12) Criteria 5, 6 and 9 are functional criteria while criteria 11 and 12 are biological criteria.
Considering a score of 4 or 5 as failure means that a re-intervention on the tooth (score 4) would be considered as a failure in the context of this study.
Adverse events will be recorded and reported as general safety outcomes.
Time Frame
one year of follow-up.
Secondary Outcome Measure Information:
Title
Contribution of the functional and biological dimensions of the five FDI criteria items
Description
Assessment of the relative importance of each of the 5 FDI criteria in determining failure for both the primary outcome
Time Frame
At one year of follow-up.
Title
Probability of success in arm P (Partial Caries Removal) compared to arm C (Complete Caries Removal) using a composite criteria of success summarized as a binary success criteria, at two and three years of follow-up.
Description
same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Time Frame
At two and three years of follow-up.
Title
Probability of success after the use of an antibacterial adhesive compared to the use of a non-antibacterial adhesive using a composite criteria of success summarized as a binary success criteria, at one, two and three years of follow-up.
Description
same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Time Frame
At one, two and three years of follow-up.
Title
Identification of predictive factors of clinical success from among the following list: presence of post-operative pain, age of patient, type of the carious lesion, location of the carious lesion (occlusal or proximal) and pulp exposure.
Description
the dependent variable (clinical success) corresponds to the same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Time Frame
At one, two and three years of follow-up.
Title
Description of the Consequences of Failures per Treatment Arm
Description
total number of visits, need for endodontic treatment, need for extraction
Time Frame
At one, two and three years of follow-up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
Patient consulting in one of the multicenter trial centers
Male and female aged 8-80 (inclusive),
Affiliated to a social security regimen
Able to tolerate necessary restorative procedures
Provide informed consent
Accepts the three-year follow-up period
Tooth related criteria:
Mature permanent posterior tooth
Tooth with vital pulp according to pulp-sensitivity tests
Tooth with a deep (primary or secondary) at least proximal and/or occlusal carious lesion presenting a residual dentin thickness with no continuity between the carious cavity and the pulp chamber.
In case of proximal lesions, the proximal cervical limit must allow proper placement of a waterproof dental dam (confirmed by a bitewing X-ray radiograph)
Tooth requiring a direct partial restorative treatment.
Randomization n°2 - Antibacterial vs. non antibacterial adhesive application
Tooth has been assigned a treatment by randomization n°1.
Exclusion Criteria:
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
Person under guardianship, pregnant or nursing woman,
Risk of infectious endocarditis,
Patient who has an implanted Cardiac Pacemaker/Defibrillator
Patient with severe periodontal disease (pocket depth ≥5mm and/or mobility type IV),
Poor oral hygiene (abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin = score 3 [Silness and Loe, 1964],
Allergy to any of the materials and/or anaesthetic used,
Uncooperative patients.
Tooth related criteria:
Nocturnal pain causing insomnia,
Tooth suffering dentin hypersensitivity (sharp sudden pain of short duration pain arising from exposed dentin (erosion and/or gingival recession), typically in response to external stimuli (air blast hypersensitivity [Schiff et al., 1994], tactile hypersensitivity),
Sensitivity to axial or lateral percussion;
Radiolucent apical image,
Condensing osteitis,
Tooth having an external or internal resorption,
Tooth having suffered trauma,
Tooth with a carious cervical lesion,
Tooth with an occlusal wear associated to a dentine exposure,
Tooth supporting clasp of a removable partial denture (RPD).
Tooth with defects of mineralization that once the treated tooth could come into contact of the carried out restoration
Randomization n°2 - Antibacterial vs. non antibacterial adhesive application
- Tooth with pulp exposure after randomization n°1 requiring endodontic treatment (pulp exposure > 2 mm² and/or haemostasis not obtained).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BRIGITTE GROSGOGEAT, Professor
Phone
04 78 77 86 89
Email
brigitte.grosgogeat@univ-lyon1.fr
First Name & Middle Initial & Last Name or Official Title & Degree
François GUEYFFIER, Professor
Phone
04 78 78 57 55
Email
francois.gueyffier@univ-lyon1.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BRIGITTE GROSGOGEAT, Professor
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DOMEJEAN Sophie
Phone
+33 6 63 04 71 43
Email
sophie.domejean@udamail.fr
First Name & Middle Initial & Last Name & Degree
DOMEJEAN Sophie
Facility Name
Hôpital Albert Chenevier
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DURSUN Elisabeth
Phone
+33 6 12 37 56 14
Email
elisabeth.dursun@parisdescartes.fr
First Name & Middle Initial & Last Name & Degree
DURSUN Elisabeth
First Name & Middle Initial & Last Name & Degree
LANDRU Marguerite-Marie
Facility Name
Cabinet Libéral
City
Grenay
ZIP/Postal Code
62160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TRENTESAUX Thomas
Phone
+33 676285205
Email
thomas.trentesaux@univ-lille2.fr
First Name & Middle Initial & Last Name & Degree
TRENTESAUX Thomas
Facility Name
Hôpital Charles Foix
City
IVRY SUR SEINE Cedex
ZIP/Postal Code
94205
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRON-CHABOUIS Hélène
Phone
+33 6 22 78 72 64
Email
fronhelene@gmail.com
First Name & Middle Initial & Last Name & Degree
FRON-CHABOUIS Hélène
First Name & Middle Initial & Last Name & Degree
DECUP Franck
First Name & Middle Initial & Last Name & Degree
ATTAL Jean-Pierre
First Name & Middle Initial & Last Name & Degree
CHATELAIN Claire
Facility Name
CHU Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LINEZ Marc
Phone
+33 6 42 53 80 79
Email
marc.linez@univ-lille2.fr
First Name & Middle Initial & Last Name & Degree
LINEZ Marc
First Name & Middle Initial & Last Name & Degree
GAMBIEZ Alain
First Name & Middle Initial & Last Name & Degree
HILDELBERT Pierre
First Name & Middle Initial & Last Name & Degree
BECAVIN Thibault
First Name & Middle Initial & Last Name & Degree
ROBBERECHT Lieven
First Name & Middle Initial & Last Name & Degree
TRENTESAUX Thomas
First Name & Middle Initial & Last Name & Degree
CATTEAU Céline
Facility Name
Service de consultations et traitements dentaires
City
Lyon
ZIP/Postal Code
69007
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VILLAT Cyril
Phone
+33 6 09 98 64 32
Email
cyril.villat@univ-lyon1.fr
First Name & Middle Initial & Last Name & Degree
VILLAT Cyril
First Name & Middle Initial & Last Name & Degree
LUCCHINI Marion
First Name & Middle Initial & Last Name & Degree
GASQUI Marie-Agnès
First Name & Middle Initial & Last Name & Degree
MORRIER Jean-Jacques
First Name & Middle Initial & Last Name & Degree
SELLI Thierry
First Name & Middle Initial & Last Name & Degree
THIVICHON-PRINCE Beatrice
First Name & Middle Initial & Last Name & Degree
GROSGOGEAT Brigitte
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RASKIN Anne
Phone
+33 4 91 38 59 55
Email
anne.raskin@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
TASSERY Hervé
First Name & Middle Initial & Last Name & Degree
JACQUOT Bruno
First Name & Middle Initial & Last Name & Degree
RASKIN Anne
Facility Name
CHRU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WEISS Pierre
Phone
+33 6 87 74 10 55
Email
pierre.weiss@univ-nantes.fr
First Name & Middle Initial & Last Name & Degree
WEISS Pierre
First Name & Middle Initial & Last Name & Degree
LOPEZ-CAZAUX Serena
First Name & Middle Initial & Last Name & Degree
ENKEL Bénédicte
First Name & Middle Initial & Last Name & Degree
PRUD'HOMME Tony
Facility Name
CHU Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BRULAT Nathalie
Phone
+33 6 95 37 73 59
Email
nathalie.brulat@unice.fr
First Name & Middle Initial & Last Name & Degree
BRULAT Nathalie
First Name & Middle Initial & Last Name & Degree
MULLER BOLLA Michèle
Facility Name
APAH Rothschild- Garancière
City
PARIS Cedex 12
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PLASSE-PRADELLE Nelly
Phone
+33 6 10 33 28 02
Email
nx.pradelle@club-internet.fr
First Name & Middle Initial & Last Name & Degree
PLASSE-PRADELLE Nelly
First Name & Middle Initial & Last Name & Degree
HARTMANN Aline
First Name & Middle Initial & Last Name & Degree
MESGOUEZ-MENEZ Catherine
Facility Name
Groupe Hospitalier Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BOSCO Julia
Phone
+33 6 60 76 94 90
Email
julia.bosco@univ-paris-diderot.fr
First Name & Middle Initial & Last Name & Degree
BOSCO Julia
First Name & Middle Initial & Last Name & Degree
HOUARI Sophia
Facility Name
Cabinet Libéral
City
Paris
ZIP/Postal Code
75017
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DECUP Franck
Phone
+33 607126524
Email
franck.decup@orange.fr
First Name & Middle Initial & Last Name & Degree
DECUP Franck
Facility Name
Hopital Xavier Arnozan
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique ORIEZ-PONS
Phone
+33 679164583
Email
dominique.oriez-pons@u-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
BARSBY Terence
First Name & Middle Initial & Last Name & Degree
KEROUREDAN Olivia
First Name & Middle Initial & Last Name & Degree
AUSSEL Audrey
First Name & Middle Initial & Last Name & Degree
ORIEZ-PONS Dominique
Facility Name
CHRU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TURPIN Yann-Loïg
Phone
+33 6 74 69 53 96
Email
yturpin@univ-rennes1.fr
First Name & Middle Initial & Last Name & Degree
TURPIN Yann-Loïg
First Name & Middle Initial & Last Name & Degree
PERARD Matthieu
Facility Name
CHRU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JONIOT Sabine
Phone
+33 6 77 38 99 20
Email
s.joniot@free.fr
First Name & Middle Initial & Last Name & Degree
JONIOT Sabine
First Name & Middle Initial & Last Name & Degree
GEORGELIN-GURGEL Marie
First Name & Middle Initial & Last Name & Degree
VAYSSE Fréderic
First Name & Middle Initial & Last Name & Degree
DIEMER Franck
First Name & Middle Initial & Last Name & Degree
BONIN Bertrand
First Name & Middle Initial & Last Name & Degree
MONSARRAT Paul
12. IPD Sharing Statement
Citations:
PubMed Identifier
27527342
Citation
Villat C, Attal JP, Brulat N, Decup F, Domejean S, Dursun E, Fron-Chabouis H, Jacquot B, Muller Bolla M, Plasse-Pradelle N, Roche L, Maucort-Boulch D, Nony P, Gritsch K, Millet P, Gueyffier F, Grosgogeat B. One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial. Trials. 2016 Aug 15;17(1):404. doi: 10.1186/s13063-016-1484-0.
Results Reference
derived
Learn more about this trial
Multicenter Trial Comparing One-step Partial Caries Removal to Complete Caries Removal for the Treatment of Deep Carious Lesions in Permanent Teeth. (DECAT : DEep CAries Treatment).
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