Selective Removal to Soft Dentine vs Selective Removal to Firm Dentine for Deep Posterior Caries Lesions
Condition: Deep Caries; Pulp Exposure, Dental; Dental Caries
MeSH terms: Dental Caries; Dental Pulp Exposure
Study type: Interventional

Summary: 
      Removal of infected dentin contaminated with bacteria and remaining affected dentin detected
      as firm is the conventional strategy for the management of cavitated caries lesions.
      Recently, this strategy is termed as selective removal to firm dentin (SRFD) and seems to
      increase the potential risk of pulp exposure or loss of pulp vitality for deep caries lesions
      radiographically extending ¾ of dentin tissue. Alternatively, selective removal to soft
      dentine (SRSD) that refers to removal of caries tissue at the periphery of the cavity to firm
      dentin and remaining caries tissue detected as soft or leathery in proximity with the pulp
      might be a less invasive excavation method for deep caries lesions to maintain pulpal health.
      However, information on clinical advantages or disadvantages of SRSD and SRFD excavation
      methods is sparse and mostly rely on studies conducted for primary teeth. Moreover, clinical
      trials are needed to demonstrate the combined effect of carious removal strategies and
      calcium silicate-based materials.

      The aim of this study is comparison of clinical success rates of SRSD and SRFD techniques in
      posterior deep caries lesions. The primary outcome of the study is comparison of clinical
      success of SRSD and SRFD techniques by clinical and radiographic examination after 3 months,
      6 months, 1 year and 2 years. The secondary outcome of the study is to investigate whether or
      not calcium silicate-based materials have an effect on the success rate of the treatment.
    

Detailed description: 
      In recent years, there has been growing number of studies questioning conventional caries
      tissue removal, especially for deep caries lesions (1). In the concept of conventional caries
      tissue removal, 'affected dentin' and 'infected dentine' are widely used terms which have
      been defined by Massler (2) in 1960s. According to this concept, removal of infected dentin
      contaminated with bacteria and remaining affected dentin detected as firm suggested for the
      management of cavitated caries lesions. Recently, this removal technique is termed as
      selective removal to firm dentin (SRFD) and seems to increase the potential risk of pulp
      exposure or loss of pulp vitality for deep caries lesions radiographically extending ¾ of
      dentin tissue (3). In case of pulp exposure, direct pulp capping is the treatment of choice
      for a tooth with a vital pulp and without any inflammation predictors such as prolonged
      bleeding. However, according to results of a long term (5-10 years) retrospective study
      evaluating the treatment outcome of direct pulp capping with calcium hydroxide, 44.5% in the
      5-yr group and 79.9% in the 10-yr group had a postoperative root canal treatment or an
      extraction (4). Similarly, another restrospective study showed that over the first year after
      direct pulp capping with calcium hydroxide , almost 10% and, after 5 years, nearly 20% of the
      teeth had an unfavourable treatment outcome (5).According to results of these studies,
      survival rate of directly capped pulp tissue with calcium hydroxide seems to decrease over
      time.

      Recently, Biodentine (BD; Septodont, St Maur-des-Fosses, France), which is a calcium
      silicate-based material, has gained popularity for pulp capping treatment. The success rate
      of Biodentine reported to be 91.7% after 3 years in a recent prospective longitudinal
      randomized controlled study of vital permanent teeth with deep caries (6). Except from the
      material of choice for pulp capping, some other strategies such as selective removal to soft
      dentin (SRSD) has been recently recommended for the management of deep caries lesions with
      the aim of reducing the risk of pulp exposure.

      Accorging to report of International CariesConsensus Collaboration (ICCC) group SRSD is
      strongly recommended in deep cavitated lesions extending into ¾ of dentin tissue. Soft
      carious tissue is left over the pulp to avoid pulpal exposure and peripheral enamel and
      dentine are prepared to hard dentine, to provide hermetic sealing and durability of the
      restoration.

      In the literature, there are very few studies concerned with the clinical success of SRSD,
      incomplete caries removal (ICR) or partial caries removal (PCR). In a long term (10 years)
      prospective cinical study, the success rates of PCR technique has been reported as, 90% after
      3 years, 82% after 5 years and %63 after 10 years (7). In another clinical study comparing
      24-month pulp health outcomes of PCR and total caries removal (TCR) in primary molars, no
      significant diffrence between the two removal techninues and reduced risk for pulp exposure
      with PCR technique has been reported (8). In a recently published review, it has been
      reported that SRSD seems to be the best option for the treatment of deep caries lesions and
      the remaining caries tissue close to the pulp seems not to interfere the longevity of the
      restorations (9).Nevertheless, not much scientific evidence on clinical success of SRSD and
      SRFD excavation methods for deep carious lesions in permanent teeth could be found in the
      currently available literature. Moreover, clinical trials are needed to demonstrate the
      combined effect of carious removal strategies and calcium silicate-based materials.

      The aim of this study is comparison of clinical success rates of SRSD and SRFD techniques in
      posterior deep caries lesions of permanent teeth. This study will be carried out as a
      prospective randomized, double-blinded, clinical trial, with 2 parallel groups. Potential
      patients attending to Istanbul Medipol University Dental Clinics in Istanbul with deep
      posterior caries lesions will be invited to the study. The patients meeting the inclusion
      criteria will be recruited and randomized into SRSD group and SRFD group by block
      randomization of 2.1 ratio.

      After giving their consent to take part in the study, defined clinical procedure for each
      group will be performed. In SRFD group (Goup B), after caries removal to firm dentin calcium
      silicate based material (Biodentine) will be applied. If the excavations led to pulp
      exposure, pulp-capping with calcium silicate based material will be performed and this
      patients will be randomized to another group (Group PC).The patients in SRSD group will be
      randomized into two subgroups as Group A and Group C. In group A after caries removal to soft
      dentin calcium silicate based material (Biodentine) will be applied. In group C after caries
      removal universal adhesive material will be applied without calcium silicate based material
      placement. All the restorations will be performed by the same operator using the same
      universal adhesive and resin composite material. The observers (two independent observer) and
      the patients will be blinded for the actual intervention performed.

      The primary outcome of the study is comparison of clinical success of SRSD and SRFD
      techniques by clinical and radiographic examination after 3 months, 6 months, 1 year and 2
      years. The secondary outcome of the study is to investigate whether or not calcium
      silicate-based materials have an effect on the success rate of the treatment. Statistical
      comparisons will be performed between Group A and Group B for the primary outcome and between
      Group A and Group C for the secondary outcome.
    

Intervention name(s): Selective removal to soft dentin (SRSD); Selective removal to firm dentine (SRFD)
Intervention type(s): Procedure; Procedure
Intervention description(s): In order to prevent pulp exposure in deep caries lesions radiographically extending at least 3/4 of dentin, periphery of the cavity prepared to hard dentin while reasonable amount of soft carious tissue over the pulp is left. This caries removal strategy is termed selective removal to soft dentine.; Carious tissue is totally removed until hard dentin dry in appearance and hard on probing. This carious removal strategy is strongly recommended for shallow or moderately deep carious lesions.
Other intervention name(s): Partial caries excavation; Incomplete caries excavation; Total caries removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment