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COMPLETED Phase 3

The Children's Amalgam Trial

NCT00065988 · View on ClinicalTrials.gov ↗

Study Summary

The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only such trial in the United States, to address the potential impact of mercury exposure from amalgam restorations on neuropsychological and renal function in children.

Conditions Studied

Interventions

  • DEVICE Dispersed phase amalgam restoration /composite restoration

Study Locations (1)

Massachusetts

  • New England Research Institute — Watertown

Trial Details

FieldValue
Enrollment Target 534 participants
Start Date 1997-09
Est. Completion 2005-03
Phase Phase 3

Sponsor

Carelon Research

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00065988

The ClinicalTrials.gov registry entry for NCT00065988 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 534 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 1 intervention — of which Dispersed phase amalgam restoration /composite restoration is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00065988 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00065988 about?

NCT00065988 is a clinical study titled "The Children's Amalgam Trial". The Children's Amalgam Trial is one of only two randomized trials of its kind, and the only such trial in the United States, to address the potential impact of mercury exposure from amalgam restorations on neuropsychological and renal function in children.

What is the current status of trial NCT00065988?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 534 participants. The study started on 1997-09. Estimated completion is 2005-03.

What conditions does trial NCT00065988 study?

This clinical trial studies the following conditions: Dental Caries. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00065988?

The interventions under investigation include: Dispersed phase amalgam restoration /composite restoration (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00065988?

This trial is sponsored by Carelon Research, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00065988 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial