Deep CariesPhase 3DECATNCT02286388
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).
A Phase 3 study testing 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. and The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental). in people with Deep Caries, run by Hospices Civils de Lyon at 15 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Deep Caries
- What is being tested?
- 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. and The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 15 sitesFrance
- Study dates
- Feb 2015to Aug 2020
- Phase
- Phase 3
- 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 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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),
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- 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).
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites, 15 recruiting
- Recruiting
Hôpital Estaing
Clermont-Ferrand, 63003
DOMEJEAN Sophie, +33 6 63 04 71 43, sophie.domejean@udamail.fr
DOMEJEAN Sophie
- Recruiting
Hôpital Albert Chenevier
Créteil, 94000
DURSUN Elisabeth, +33 6 12 37 56 14, elisabeth.dursun@parisdescartes.fr
DURSUN Elisabeth
- Recruiting
Cabinet Libéral
Grenay, 62160
TRENTESAUX Thomas, +33 676285205, thomas.trentesaux@univ-lille2.fr
TRENTESAUX Thomas
- Recruiting
Hôpital Charles Foix
Ivry-sur-Seine, 94205
FRON-CHABOUIS Hélène, +33 6 22 78 72 64, fronhelene@gmail.com
FRON-CHABOUIS Hélène
- Recruiting
CHU Lille
Lille
LINEZ Marc, +33 6 42 53 80 79, marc.linez@univ-lille2.fr
LINEZ Marc
- Recruiting
Service de consultations et traitements dentaires
Lyon, 69007
VILLAT Cyril, +33 6 09 98 64 32, cyril.villat@univ-lyon1.fr
VILLAT Cyril
- Recruiting
Hôpital de la Timone
Marseille, 13385
RASKIN Anne, +33 4 91 38 59 55, anne.raskin@ap-hm.fr
TASSERY Hervé
- Recruiting
CHRU de Nantes
Nantes, 44093
WEISS Pierre, +33 6 87 74 10 55, pierre.weiss@univ-nantes.fr
WEISS Pierre
- Recruiting
CHU Nice
Nice, 06003
BRULAT Nathalie, +33 6 95 37 73 59, nathalie.brulat@unice.fr
BRULAT Nathalie
- Recruiting
Groupe Hospitalier Pitié Salpétrière
Paris, 75013
BOSCO Julia, +33 6 60 76 94 90, julia.bosco@univ-paris-diderot.fr
BOSCO Julia
- Recruiting
Cabinet Libéral
Paris, 75017
DECUP Franck, +33 607126524, franck.decup@orange.fr
DECUP Franck
- Recruiting
APAH Rothschild- Garancière
Paris, 75571
PLASSE-PRADELLE Nelly, +33 6 10 33 28 02, nx.pradelle@club-internet.fr
PLASSE-PRADELLE Nelly
- Recruiting
Hopital Xavier Arnozan
Pessac, 33604
Dominique ORIEZ-PONS, +33 679164583, dominique.oriez-pons@u-bordeaux.fr
BARSBY Terence
- Recruiting
CHRU Rennes
Rennes, 35033
TURPIN Yann-Loïg, +33 6 74 69 53 96, yturpin@univ-rennes1.fr
TURPIN Yann-Loïg
- Recruiting
CHRU Toulouse
Toulouse, 31059
JONIOT Sabine, +33 6 77 38 99 20, s.joniot@free.fr
JONIOT Sabine
About this study
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
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.
Read more
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.
- Conditions
- Deep Caries
- Being tested
- 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)
- Keywords
- Deep carious lesion, incomplete caries removal, antibacterial adhesive system, dental composite resin, pulp vitality preservation, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.Procedure or surgery
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).
A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.Procedure or surgery
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).; Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental) |
| 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 Receives: Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).; Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental) |
| Antibacterial dental adhesive | Experimental | patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment) Receives: Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).; Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental) |
| Conventional dental adhesive | Active comparator | patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment) Receives: Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.; Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).; Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year of follow-up.
Secondary outcomes (5)
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
Measured: 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.
same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)
Measured: 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)
Measured: 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)
Measured: 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
Measured: At one, two and three years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep CariesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 464 participants (estimated)
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 Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286388
- Sponsor's protocol ID
- 2014-854
- Acronym
- DECAT
- Status last verified
- Sep 2016
- First submitted
- 15 Oct 2014
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27527342
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02286388
- Acronym / sponsor ID
- DECAT / 2014-854
- Conditions
- Deep Caries
- Keywords
- Deep carious lesion, incomplete caries removal, antibacterial adhesive system, dental composite resin, pulp vitality preservation, randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 7 Nov 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Partial excavation | Experimental | Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental)., Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive |
| Complete excavation | Active comparator | Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental)., Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive |
| Antibacterial dental adhesive | Experimental | Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental)., Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment) |
| Conventional dental adhesive | Active comparator | Procedure: A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Procedure: A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth., Device: The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental)., Device: The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment) |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Randomization n°1 - Partial versus complete caries removal
- 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
Key exclusion criteria (23 listed)
- Randomization n°1 - Partial versus complete caries removal
- 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),
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 |
|---|---|---|
| A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.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). | Procedure or surgery | Antibacterial dental adhesive, Complete excavation, Conventional dental adhesive, Partial excavation |
| A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.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. | Procedure or surgery | Antibacterial dental adhesive, Complete excavation, Conventional dental adhesive, Partial excavation |
| The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).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. | Device | Antibacterial dental adhesive, Complete excavation, Conventional dental adhesive, Partial excavation |
| The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)Idem antibacterial dental adhesive arm. A conventional dental adhesive will be used instead of an antibacterial. | Device | Antibacterial dental adhesive, Complete excavation, Conventional dental adhesive, Partial excavation |
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 (cf. description below)
Time frame: one year of follow-up.
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.
5 secondary outcomes
Contribution of the functional and biological dimensions of the five FDI criteria items
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At one, two and three years of follow-up.
Description of the Consequences of Failures per Treatment Arm
Time frame: At one, two and three years of follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Derived from this study: PubMed 27527342Villat 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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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 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. and The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental). in people with Deep Caries, run by Hospices Civils de Lyon at 15 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 16 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BRIGITTE GROSGOGEAT, Professor (04 78 77 86 89, 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?
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) (time frame: one year of follow-up.). 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 NCT02286388, which also lists 1 linked publication.
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 29 Sep 2016.