deltatrials
Completed NA INTERVENTIONAL 2-arm NCT01726179

Efficacy of Proximal Caries Infiltration

Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial

Sponsor: DMG Dental Material Gesellschaft mbH

Updated 8 times since 2017 Last updated: Apr 19, 2022 Started: Dec 31, 2013 Primary completion: Dec 31, 2017 Completion: Dec 31, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Caries and Dental Health and is currently completed. DMG Dental Material Gesellschaft mbH leads this study, which shows 8 recorded versions since 2013 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.

The aim of this study is to test the clinical efficacy of caries infiltration to arrest proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test lesions) will progress significantly less than non infiltrated lesions (control lesions). Additionally, it was hypothesized that dental anxiety and stress related to caries infiltration will be significantly less than dental anxiety related to a conventional restorative procedure. The study will be a controlled clinical trial with a split mouth design and blind evaluation of the outcome (caries progression). Caries progression will be evaluated annually, 12, 24, and 36 months after treatment.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotActive Not Recruiting~Jun 2018 – ~Sep 2019 · 15 months · monthly snapshotActive Not Recruiting~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshotUnknown Status~Jan 2021 – ~May 2022 · 16 months · monthly snapshotUnknown Status~May 2022 – ~Jul 2024 · 26 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

8 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed NA

  2. Sep 2024 — Present [monthly]

    Completed NA

  3. Jul 2024 — Sep 2024 [monthly]

    Completed NA

  4. May 2022 — Jul 2024 [monthly]

    Completed NA

    Status: Unknown StatusCompleted

  5. Jan 2021 — May 2022 [monthly]

    Unknown Status NA

Show 3 earlier versions
  1. Sep 2019 — Jan 2021 [monthly]

    Unknown Status NA

    Status: Active Not RecruitingUnknown Status

  2. Jun 2018 — Sep 2019 [monthly]

    Active Not Recruiting NA

  3. Jan 2017 — Jun 2018 [monthly]

    Active Not Recruiting NA

    First recorded

Dec 2013

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • DMG Dental Material Gesellschaft mbH
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)
  • Universidade Federal do Rio de Janeiro
Data source: DMG Dental Material Gesellschaft mbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations