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Selective Removal to Soft Dentine vs Selective Removal to Firm Dentine for Deep Posterior Caries Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052685
Recruitment Status : Active, not recruiting
First Posted : August 12, 2019
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Istanbul Medipol University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Deep Caries Pulp Exposure, Dental Dental Caries Procedure: Selective removal to soft dentin (SRSD) Procedure: Selective removal to firm dentine (SRFD) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Selective Removal to Soft Dentine or Selective Removal to Firm Dentine for Deep Caries Lesions in Permanent Posterior Teeth: A Randomized Controlled Trial up to 2 Years
Actual Study Start Date : November 28, 2018
Actual Primary Completion Date : March 3, 2020
Estimated Study Completion Date : March 28, 2022

Arm Intervention/treatment
Experimental: Selective removal to soft dentin (SRSD)
The patients in SRSD group will be randomized into two subgroups as Group A and Group C. After caries removal to soft dentin calcium silicate based material (Biodentine) will be applied in Group A while will not be applied in Group C prior to placement of the resin composite restoration. The procedure, starts with access to caries tissue by the removal of surrounding unsupported enamel.Carious tissue at the periphery of the cavity will be prepared to hard dentin using round tungsten carbide burs and/or an excavator, while soft carious dentin will remain in the pulpal aspect of the cavity to prevent pulp exposure. Operative procedures will be performed by an experienced (over 10 years) specialist. Moisture control will be provided using cotton rolls and continuous aspiration.
Procedure: Selective removal to soft dentin (SRSD)
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.
Other Names:
  • Partial caries excavation
  • Incomplete caries excavation

Active Comparator: Selective removal to firm dentin (SRSD)
Procedures will be done using local anesthesia. The procedure, starts with access to caries tissue by the removal of surrounding unsupported enamel. Caries tissue in the periphery including the enamel-dentinal junction will be removed using round tungsten carbide burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries tissue will be removed until hard or leathery dentin remains. Operative procedures will be performed by an experienced (over 10 years) specialist. Moisture control will be provided using cotton rolls and continuous aspiration. Restoration will be performed after caries removal to firm dentin and placement of calcium silicate based material (Biodentine).
Procedure: Selective removal to firm dentine (SRFD)
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 Name: Total caries removal




Primary Outcome Measures :
  1. Success (endodontic treatment required no/yes) [ Time Frame: 24 months ]

    The primary outcome of the study will be success (i. e. not requiring root canal treatment intervention).

    Pulp vitality (yes/no), pain on percussion or palpation (yes/no), presence of abscess or fistula (yes/no) will assessed clinically. Radiographically, periradicular pathology (yes/no), pathologic calcification or resorption (yes/no) will be assessed.


  2. Post-operative sensitivity (yes/no) [ Time Frame: Directly after treatment within the first week. ]
    The second outcome of the study will depend on Patients' subjective assessment of the treatment (severe/moderate/no)


Secondary Outcome Measures :
  1. Dentin bridge formation [ Time Frame: 24 months ]
    Whether or not placement of calcium silicate based material (Biodentine) has an extra benefit for dentin bridge formation (dentin bridge formation yes/no)

  2. Restoration integrity [ Time Frame: 24 months ]

    Restorations will be evaluated according to FDI World Dental Federation criteria (10). This instrument is composed of three dimensions (biological, functional and esthetic). Some items are evaluated quantitatively, others visually.The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome (1:excellent; 2:clinically good; 3:clinically satisfactory; 4:unsatisfactory but repairable; 5: replacement necessary).

    Esthetic Properties:

    • Surface Luster (1-5)
    • Staining (1-5)
    • Color match and translucency (1-5)
    • Anatomical form (1-5)

    Functional Properties:

    • Fracture of material and retention (1-5)
    • Marginal adaptation (1-5)
    • Occlusal wear (1-5)
    • Approximal anatomical form (1-5)
    • Radiographic examination (1-5)
    • Patient's view (1-5)

    Biological Properties

    • Recurrence of caries (1-5)
    • Tooth integrity (1-5)



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Deep primary active caries lesion extending at least 3/4 of dentin
  • No irreversible pulpitis symptoms
  • Positive response to electrical and cold pulp vitality tests
  • Good general health
  • No untreated periodontal disease
  • Acceptance to be included in study

Exclusion Criteria:

  • Irreversible pulpitis symptoms
  • Negative response to electrical and cold pulp vitality tests
  • Radiographically periradicular pathology
  • Pregnancy
  • Teeth with non-carious lesions (attrition, erosion, abrasion or abfraction)
  • Patients planning bleaching or orthodontic treatment
  • Known allergy to study material

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): NCT04052685


Locations
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Turkey
Istanbul Medipol University, School of Dentistry
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Medipol University Hospital
Investigators
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Study Director: Mutlu Özcan, DDS,PhD Zurich University
Publications:

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Responsible Party: Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT04052685    
Other Study ID Numbers: 10840098-604.01.01-E.53565
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Dental Pulp Exposure
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Dental Pulp Diseases