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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial excavation | Experimental | patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive |
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| Complete excavation | Active Comparator | patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive |
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| Antibacterial dental adhesive | Experimental | patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth. | Procedure | Instruments and procedures:
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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | one year of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At one year of follow-up. |
| 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. |
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Inclusion Criteria:
Randomization n°1 - Partial versus complete caries removal
Patient-related criteria:
Tooth related criteria:
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:
Tooth related criteria:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BRIGITTE GROSGOGEAT, Professor | Contact | 04 78 77 86 89 | brigitte.grosgogeat@univ-lyon1.fr | |
| François GUEYFFIER, Professor | Contact | 04 78 78 57 55 | francois.gueyffier@univ-lyon1.fr |
| Name | Affiliation | Role |
|---|---|---|
| BRIGITTE GROSGOGEAT, Professor | Hospices Civils de Lyon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Estaing | Recruiting | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27527342 | Derived | 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. |
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| Conventional dental adhesive | Active Comparator | patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment) |
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| A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth. | Procedure | 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. |
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| The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental). | Device | 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. |
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| The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental) | Device | Idem antibacterial dental adhesive arm. A conventional dental adhesive will be used instead of an antibacterial. |
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same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria) |
| At two and three years of follow-up. |
| 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) | At one, two and three years of follow-up. |
| 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) | At one, two and three years of follow-up. |
| Description of the Consequences of Failures per Treatment Arm | total number of visits, need for endodontic treatment, need for extraction | At one, two and three years of follow-up. |
| Hôpital Albert Chenevier | Recruiting | Créteil | 94000 | France |
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| Cabinet Libéral | Recruiting | Grenay | 62160 | France |
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| Hôpital Charles Foix | Recruiting | Ivry-sur-Seine | 94205 | France |
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| CHU Lille | Recruiting | Lille | France |
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| Service de consultations et traitements dentaires | Recruiting | Lyon | 69007 | France |
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| Hôpital de la Timone | Recruiting | Marseille | 13385 | France |
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| CHRU de Nantes | Recruiting | Nantes | 44093 | France |
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| CHU Nice | Recruiting | Nice | 06003 | France |
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| Groupe Hospitalier Pitié Salpétrière | Recruiting | Paris | 75013 | France |
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| Cabinet Libéral | Recruiting | Paris | 75017 | France |
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| APAH Rothschild- Garancière | Recruiting | Paris | 75571 | France |
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| Hopital Xavier Arnozan | Recruiting | Pessac | 33604 | France |
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| CHRU Rennes | Recruiting | Rennes | 35033 | France |
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| CHRU Toulouse | Recruiting | Toulouse | 31059 | France |
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