NCT04092296

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

September 14, 2019

Last Update Submit

September 14, 2019

Conditions

Caries; Initial

Outcome Measures

Primary Outcomes (1)

  • pairwise bitewing radiograph and DIAGNOcam image

    comparing the outcome of bitewing radiograph and DIAGNOcam image of pre- and post- operation

    after three years

Secondary Outcomes (1)

  • compare the cost-effectiveness between resin infiltration and remineralization

    after three year years

Study Arms (2)

resin infiltration

EXPERIMENTAL

resin infiltrant (Icon product, DMG, Hamburg,Germany)

Other: resin infiltration

remineralization

ACTIVE COMPARATOR
Other: remineralizationOther: sham

Interventions

resin infiltrationOTHER

using infiltrant resin intervene proximal caries

resin infiltration
remineralizationOTHER

using fluoride to remineralize proximal caries

remineralization
shamOTHER

replace resin with water

remineralization

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • patient who diagnosed with dentinogenesis imperfecta

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan university

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Interventions

Tooth Remineralizationsalicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

  • liuyan meng, dovtor

    Hospital of Stomatology, Wuhan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

fei wang

CONTACT

15927529467121565382@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
graduate student

Study Record Dates

First Submitted

September 14, 2019

First Posted

September 17, 2019

Study Start

August 10, 2018

Primary Completion

December 10, 2019

Study Completion

August 10, 2021

Last Updated

September 17, 2019

Record last verified: 2019-09

Locations

CN(1)