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Pulp Protection in Selective Carious Tissue Removal (PULPROTECT)

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ClinicalTrials.gov Identifier: NCT04250142
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Rodrigo A. Giacaman, University of Talca

Tracking Information
First Submitted Date  ICMJE January 29, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE March 13, 2019
Estimated Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Restoration integrity [ Time Frame: 2 years ]
    The FDI Criteria will be used for the direct clinical evaluation of restorations.
  • Pulp vitality [ Time Frame: 2 years ]
    Pulp vitality will be evaluated by means of symptoms reported by the patient, normal response upon thermal tests, no pain upon percussion, absence of periapical lesions (periapical radiography) and absence of infectious processes such as fistula.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Radiographic progression [ Time Frame: 2 years ]
    Lesion progression at the x-ray will be monitored through qualitative analysis with the technique of digital subtraction of the radiographic images (radiolucent area under restorations) over time.
  • Changes in pulp chamber morphology [ Time Frame: 2 years ]
    For the qualitative analysis of the depth of the lesion and the deposition of tertiary dentin, the pairs of radiographic images (baseline radiographs versus control radiographs) will be assessed and compared.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulp Protection in Selective Carious Tissue Removal
Official Title  ICMJE Effect of Pulp Protection After Selective Carious Tissue Removal in Permanent Teeth, a Randomized Controlled Clinical Trial
Brief Summary Although selective removal of carious tissue to soft dentin (SRCT-S) has been proposed as the standard of care for the management of deep dentin caries, it is unclear whether a cavity liner is necessary. This double blinded randomized controlled clinical trial aims to analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. The study will include 142 restorations allocated to either experimental arm. After 12 and 24 months, restoration survival, pulp response and radiographic lesion progression will be assessed.
Detailed Description Introduction: Minimally invasive dentistry has been proposed as an conceptual framework for the conservative management of caries lesions. This approach allows reducing potential adverse effects derived from the conventional treatment, including the loss of pulp vitality. Complete removal carious tissues compromising deep dentin significantly increases the risk of pulp exposure and post-operative symptoms, leading in many cases, to the need for endodontic treatment, with the subsequent high costs and low coverage for the population. In this context, a new technique for the management of deep caries lesions has been introduced called selective removal of carious tissue to soft dentin (SRCT-S), which partially removes only the outer layer of the affected tissue, leaving carious tissue in the pulpal wall, but not on the lateral walls of the operatory cavity. This procedure has been reported in several studies, with lower clinical time, cheaper cost and lower discomfort for the patient. The SRCT-S aims to preserve pulp vitality, prevent access of nutrients to carious tissue, stopping the caries process and preserving a greater amount of dental structure. Although the SRCT-S technique has proven effective compared to conventional treatments, it is unclear and with insufficient evidence about how to manage the remaining carious tissue and whether a cavity lining agent is needed. This decision may have important clinical implications, but there is no general consensus, strongly suggesting further research. Objective: To analyze the behavior of a resin restoration performed after SRCT-S for deep dentin caries, treated either with a Glass Ionomer or only with a Self-Etching Adhesive, in permanent teeth. Methodology: A double blinded randomized controlled clinical trial was devised. Trained dentists will treat the 142 restorations included in deep dentin carious lesions of permanent molars, at the dental clinics of the University of Talca. After recruiting, patients will be randomly assigned to the experimental groups: Group 1: (n=71) no cavity lining, treating carious tissue with self-conditioning adhesive followed by composite resin restoration and Group 2: (n=71) remaining carious tissue covered with a conventional glass ionomer followed by composite resin restoration. The dependent variables (outcomes) will be; a. clinical: restoration survival and pulp response and b. radiographic: lesion progression. Clinical and radiographic outcomes will be monitored annually at 12 and 24 months. The analysis of the restorations and the pulp response will be performed with Weibull regression. The Friedman test will be applied for the analysis of the data regarding radiographic subtraction, (p≤0.05). Given the lack of studies on the subject with longitudinal evaluations, this project is expected to contribute relevant evidence that impacts the generation of novel guidelines for the management of deep dentin caries. Additionally, the results will contribute evidence to increase the support to a more conservative clinical behavior.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A double blinded randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Subjects will not know the type of treatment they will receive. The data analysis will be carried out assigning a letter to the treatment arms, and the identity of the arms will not be revealed up until the end of the analysis.
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Device: Self-etching Adhesive
    A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
    Other Names:
    • Self-conditioning Adhesive
    • Self-etching primer
    • Single Bond Universal (3M)
  • Device: Glass Ionomer
    A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
    Other Names:
    • Conventional Glass Ionomer
    • Ketac Molar (3M)
Study Arms  ICMJE
  • Active Comparator: Conventional Glass Ionomer
    Selective removal of carious tissue to soft dentin. Deep carious dentin will be lined by a conventional glass ionomer, followed by a composite resin restoration.
    Intervention: Device: Glass Ionomer
  • Experimental: Self-etching Adhesive
    Selective removal of carious tissue to soft dentin. Deep carious dentin will not be lined and a self-etching adhesive will cover the tissue, followed by a composite resin restoration.
    Intervention: Device: Self-etching Adhesive
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
142
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 18, 2022
Estimated Primary Completion Date December 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with a permanent molar or premolar with a deep caries lesion that compromises from the inner half of the dentin (determined by radiographic examination).
  • Tooth restorable by a direct resin restoration.
  • Absence of pulp sensibility verified by cold test
  • Absence of a history of spontaneous pain or vertical and horizontal percussion.
  • Absence of periapical lesion, verified through periapical radiographs.
  • Primary injury.

Exclusion Criteria:

  • Systemic conditions with poor control or uncompensated.
  • Cervical margin of the cavity in dentin or root cement.
  • Tooth already restored or with secondary caries.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rodrigo A Giacaman, DDS, PhD +56712201546 giacaman@utalca.cl
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250142
Other Study ID Numbers  ICMJE CM-11/2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rodrigo A. Giacaman, University of Talca
Study Sponsor  ICMJE University of Talca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cecilia Muñoz Sandoval, DDS University of Talca
PRS Account University of Talca
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP