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Efficacy of Resin Infiltration of Proximal Caries (RIDCBW)

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: NCT04092296
Recruitment Status : Recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Fei Wang, Wuhan University

Brief Summary:
The aim of the present study was to assess the clinical efficacy of resin infiltration of interproximal caries lesions using a novel measure method-----DIAGNOcam. This study is conducted on adults (15-40y)with the aim of comparing the therapeutic effects of infiltrating caries lesions and fluoride remineralization treatment after 1, 2, and 3 yrs. The outcome (lesion progression) is evaluated by DIAGNOcam and radiographic techniques.And we would compare the sensitivity of monitoring progression of caries between DIAGNOcam and bitewing radiography.

Condition or disease Intervention/treatment Phase
Caries; Initial Other: resin infiltration Other: remineralization Other: sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Resin Infiltration of Proximal Caries Tested With DIAGNOcam and Bitewing Radiography:Randomized Controlled Clinical Trial
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : August 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Arm Intervention/treatment
Experimental: resin infiltration
resin infiltrant (Icon product, DMG, Hamburg,Germany)
Other: resin infiltration
using infiltrant resin intervene proximal caries

Active Comparator: remineralization Other: remineralization
using fluoride to remineralize proximal caries

Other: sham
replace resin with water




Primary Outcome Measures :
  1. pairwise bitewing radiograph and DIAGNOcam image [ Time Frame: after three years ]
    comparing the outcome of bitewing radiograph and DIAGNOcam image of pre- and post- operation


Secondary Outcome Measures :
  1. compare the cost-effectiveness between resin infiltration and remineralization [ Time Frame: after three year years ]
    calculate the consumption of infiltrant and Duraphat,combined with the effectiveness



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

individuals who want to participate in the study ,the presence of 2 or more non-cavitated interproximal caries lesions with dark shadow involved in the enamel on the DIAGNOcam image -

Exclusion Criteria:

  • patient who diagnosed with dentinogenesis imperfecta

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): NCT04092296


Contacts
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Contact: fei wang 15927529467 121565382@qq.com

Locations
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China, Hubei
Wuhan university Recruiting
Wuhan, Hubei, China
Contact: fei wang, graduate    15927529467    121565382@qq.com   
Contact: liuyan meng, doctor    15827652404    mengliuyan@whu.edu.cn   
Sponsors and Collaborators
Wuhan University
Investigators
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Principal Investigator: liuyan meng, dovtor Hospital of Stomatology, Wuhan University

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Responsible Party: Fei Wang, graduate student, Wuhan University
ClinicalTrials.gov Identifier: NCT04092296    
Other Study ID Numbers: 20180103
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No