Pulp Protection in Selective Carious Tissue Removal (PULPROTECT)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04250142|
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Device: Self-etching Adhesive Device: Glass Ionomer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||142 participants|
|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.|
|Official Title:||Effect of Pulp Protection After Selective Carious Tissue Removal in Permanent Teeth, a Randomized Controlled Clinical Trial|
|Actual Study Start Date :||March 13, 2019|
|Estimated Primary Completion Date :||December 23, 2021|
|Estimated Study Completion Date :||March 18, 2022|
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.
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.
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.
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.
- 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.
- 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.
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): NCT04250142
|Contact: Rodrigo A Giacaman, DDS, PhDfirstname.lastname@example.org|
|Faculty of Health Sciences||Recruiting|
|Talca, No State, Chile, 3460000|
|Contact: Carlos Padilla, MSc 56-712-201451 email@example.com|
|Contact: Rodrigo A Giacaman, DDS, PhD 56-712-201504 firstname.lastname@example.org|
|Principal Investigator: Rodrigo A Giacaman, DDS, PhD|
|Sub-Investigator: Cecilia Muñoz, DDS|
|Study Director:||Cecilia Muñoz Sandoval, DDS||University of Talca|