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
试验速览
- 阶段
- 3 期
- 入组人数
- 464
- 试验地点
- 28
- 主要终点
- 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)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
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)
时间窗: 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.
次要结局
- Contribution of the functional and biological dimensions of the five FDI criteria items(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.(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.(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.(At one, two and three years of follow-up.)
- Description of the Consequences of Failures per Treatment Arm(At one, two and three years of follow-up.)