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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). (DECAT)

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ClinicalTrials.gov Identifier: NCT02286388
Recruitment Status : Recruiting
First Posted : November 7, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Deep Caries 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) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 464 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Partial excavation
patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
Procedure: 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: 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.


Device: 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: 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.

Active Comparator: Complete excavation
patients receiving after excavation (in case of absence of pulp exposure after excavation necessitating endodontic treatment) antibacterial adhesive or non-antibacterial adhesive
Procedure: 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: 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.


Device: 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: 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.

Experimental: Antibacterial dental adhesive
patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
Procedure: 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: 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.


Device: 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: 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.

Active Comparator: Conventional dental adhesive
patients with prior partial or complete caries removal (excepted patients with a pulp exposure after excavation necessitating endodontic treatment)
Procedure: 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: 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.


Device: 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: 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.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Contribution of the functional and biological dimensions of the five FDI criteria items [ Time Frame: At one year of follow-up. ]
    Assessment of the relative importance of each of the 5 FDI criteria in determining failure for both the primary outcome

  2. 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. ]
    same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)

  3. 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. ]
    same criteria as the primary outcome measure of efficacy (composite criteria summarized as a binary success criteria)

  4. 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. ]
    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)

  5. Description of the Consequences of Failures per Treatment Arm [ Time Frame: At one, two and three years of follow-up. ]
    total number of visits, need for endodontic treatment, need for extraction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286388


Contacts
Contact: BRIGITTE GROSGOGEAT, Professor 04 78 77 86 89 brigitte.grosgogeat@univ-lyon1.fr
Contact: François GUEYFFIER, Professor 04 78 78 57 55 francois.gueyffier@univ-lyon1.fr

Locations
France
Hôpital Estaing Recruiting
Clermont Ferrand, France, 63003
Contact: DOMEJEAN Sophie    +33 6 63 04 71 43    sophie.domejean@udamail.fr   
Principal Investigator: DOMEJEAN Sophie         
Hôpital Albert Chenevier Recruiting
Creteil, France, 94000
Contact: DURSUN Elisabeth    +33 6 12 37 56 14    elisabeth.dursun@parisdescartes.fr   
Principal Investigator: DURSUN Elisabeth         
Sub-Investigator: LANDRU Marguerite-Marie         
Cabinet Libéral Recruiting
Grenay, France, 62160
Contact: TRENTESAUX Thomas    +33 676285205    thomas.trentesaux@univ-lille2.fr   
Principal Investigator: TRENTESAUX Thomas         
Hôpital Charles Foix Recruiting
IVRY SUR SEINE Cedex, France, 94205
Contact: FRON-CHABOUIS Hélène    +33 6 22 78 72 64    fronhelene@gmail.com   
Principal Investigator: FRON-CHABOUIS Hélène         
Sub-Investigator: DECUP Franck         
Sub-Investigator: ATTAL Jean-Pierre         
Sub-Investigator: CHATELAIN Claire         
CHU Lille Recruiting
Lille, France
Contact: LINEZ Marc    +33 6 42 53 80 79    marc.linez@univ-lille2.fr   
Principal Investigator: LINEZ Marc         
Sub-Investigator: GAMBIEZ Alain         
Sub-Investigator: HILDELBERT Pierre         
Sub-Investigator: BECAVIN Thibault         
Sub-Investigator: ROBBERECHT Lieven         
Sub-Investigator: TRENTESAUX Thomas         
Sub-Investigator: CATTEAU Céline         
Service de consultations et traitements dentaires Recruiting
Lyon, France, 69007
Contact: VILLAT Cyril    +33 6 09 98 64 32    cyril.villat@univ-lyon1.fr   
Principal Investigator: VILLAT Cyril         
Sub-Investigator: LUCCHINI Marion         
Sub-Investigator: GASQUI Marie-Agnès         
Sub-Investigator: MORRIER Jean-Jacques         
Sub-Investigator: SELLI Thierry         
Sub-Investigator: THIVICHON-PRINCE Beatrice         
Principal Investigator: GROSGOGEAT Brigitte         
Hôpital de la Timone Recruiting
Marseille, France, 13385
Contact: RASKIN Anne    +33 4 91 38 59 55    anne.raskin@ap-hm.fr   
Sub-Investigator: TASSERY Hervé         
Sub-Investigator: JACQUOT Bruno         
Principal Investigator: RASKIN Anne         
CHRU de Nantes Recruiting
Nantes, France, 44093
Contact: WEISS Pierre    +33 6 87 74 10 55    pierre.weiss@univ-nantes.fr   
Principal Investigator: WEISS Pierre         
Sub-Investigator: LOPEZ-CAZAUX Serena         
Sub-Investigator: ENKEL Bénédicte         
Sub-Investigator: PRUD'HOMME Tony         
CHU Nice Recruiting
Nice, France, 06003
Contact: BRULAT Nathalie    +33 6 95 37 73 59    nathalie.brulat@unice.fr   
Principal Investigator: BRULAT Nathalie         
Sub-Investigator: MULLER BOLLA Michèle         
APAH Rothschild- Garancière Recruiting
PARIS Cedex 12, France, 75571
Contact: PLASSE-PRADELLE Nelly    +33 6 10 33 28 02    nx.pradelle@club-internet.fr   
Principal Investigator: PLASSE-PRADELLE Nelly         
Sub-Investigator: HARTMANN Aline         
Sub-Investigator: MESGOUEZ-MENEZ Catherine         
Groupe Hospitalier Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: BOSCO Julia    +33 6 60 76 94 90    julia.bosco@univ-paris-diderot.fr   
Principal Investigator: BOSCO Julia         
Sub-Investigator: HOUARI Sophia         
Cabinet Libéral Recruiting
Paris, France, 75017
Contact: DECUP Franck    +33 607126524    franck.decup@orange.fr   
Principal Investigator: DECUP Franck         
Hopital Xavier Arnozan Recruiting
Pessac, France, 33604
Contact: Dominique ORIEZ-PONS    +33 679164583    dominique.oriez-pons@u-bordeaux.fr   
Sub-Investigator: BARSBY Terence         
Sub-Investigator: KEROUREDAN Olivia         
Sub-Investigator: AUSSEL Audrey         
Principal Investigator: ORIEZ-PONS Dominique         
CHRU Rennes Recruiting
Rennes, France, 35033
Contact: TURPIN Yann-Loïg    +33 6 74 69 53 96    yturpin@univ-rennes1.fr   
Principal Investigator: TURPIN Yann-Loïg         
Sub-Investigator: PERARD Matthieu         
CHRU Toulouse Recruiting
Toulouse, France, 31059
Contact: JONIOT Sabine    +33 6 77 38 99 20    s.joniot@free.fr   
Principal Investigator: JONIOT Sabine         
Sub-Investigator: GEORGELIN-GURGEL Marie         
Sub-Investigator: VAYSSE Fréderic         
Sub-Investigator: DIEMER Franck         
Sub-Investigator: BONIN Bertrand         
Sub-Investigator: MONSARRAT Paul         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Study Director: BRIGITTE GROSGOGEAT, Professor Hospices Civils de Lyon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02286388     History of Changes
Other Study ID Numbers: 2014-854
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Hospices Civils de Lyon:
Deep carious lesion
incomplete caries removal
antibacterial adhesive system
dental composite resin
pulp vitality preservation
randomized controlled trial

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents