Comparison of the Treatment Outcomes of the Conventional Stainless Steel Crown Restorations and the Hall Technique in the Treatment of Carious Primary Molars

September 16, 2024 updated by: Le Van Nhat Thang, Hue University of Medicine and Pharmacy
Stainless steel crowns have shown high success in restoring carious primary molars over a longer period of time than conventional restorations. This study aims to evaluate the treatment effectiveness of conventional SSCs restoration and Hall technique in treating carious primary molars

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Thua Thien Hue
      • Huế, Thua Thien Hue, Vietnam, 49120
        • Recruiting
        • Hue University of Medicine and Pharmacy
        • Contact:
        • Contact:
          • Van Nhat Thang Le, DDS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Agree and voluntarily participate in the research (with the patient's parent/guardian consent for participation)
  2. Children have a primary molar with at least 2 carious lesions corresponding to International Caries Detection and Assessment System (ICDAS) scores 4 or at least 1 carious lesion corresponding to ICDAS scores 5 and 6.

Exclusion Criteria:

  1. Children with systemic diseases such as immunodeficiency, cardiovascular disease, or bleeding disorders.
  2. Children are allergic to nickel and resin.
  3. Children unable to return for recall visits.
  4. Primary molar has signs of pulpal/periapical diseases (irreversible pulpitis, pulp necrosis, loosening, fistula, or abscess).
  5. Children are undergoing orthodontic treatment with fixed or removable appliances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Conventional Technique
A stainless steel crown will place on a carious primary molar after preparation
Procedure: Placement of stainless steel crowns on primary molars
Preformed metal crowns have been placed to treat caries in primary molars
Experimental: Hall technique
A stainless steel crown will place on a carious primary molar without local anesthesia caries removal or any preparation
Procedure: Placement of stainless steel crowns on primary molars
Preformed metal crowns have been placed to treat caries in primary molars

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Failure of stainless steel crowns
Time Frame: 3 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
3 months
Failure of stainless steel crowns
Time Frame: 6 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
6 months
Failure of stainless steel crowns
Time Frame: 9 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
9 months
Failure of stainless steel crowns
Time Frame: 12 months
Level 1 failures was considered when there were any signs of failure related to SSCs. Level 2 failures was considered when there were any signs of related pulpal and periapical pathology. Success was considered when Level 1 and 2 failures were absent.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occlusal contact
Time Frame: 0 months
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
0 months
Occlusal contact
Time Frame: 3 months
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
3 months
Occlusal contact
Time Frame: 6 months
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
6 months
Occlusal contact
Time Frame: 9 months
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
9 months
Occlusal contact
Time Frame: 12 months
Occlusal contact was assessed as follows: normal occlusion or rised occlusion.
12 months
Periodontal health
Time Frame: 0 months

  • Plaque index 0 = No plaque in the gingival area.

    1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
    2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
    3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

  • Gingival index 0 = Normal gingiva

    1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
    2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
    3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
0 months
Periodontal health
Time Frame: 3 months

  • Plaque index 0 = No plaque in the gingival area.

    1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
    2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
    3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

  • Gingival index 0 = Normal gingiva

    1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
    2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
    3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
3 months
Periodontal health
Time Frame: 6 months

  • Plaque index 0 = No plaque in the gingival area.

    1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
    2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
    3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

  • Gingival index 0 = Normal gingiva

    1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
    2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
    3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
6 months
Periodontal health
Time Frame: 9 months

  • Plaque index 0 = No plaque in the gingival area.

    1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
    2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
    3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

  • Gingival index 0 = Normal gingiva

    1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
    2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
    3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
9 months
Periodontal health
Time Frame: 12 months

  • Plaque index 0 = No plaque in the gingival area.

    1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
    2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
    3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

  • Gingival index 0 = Normal gingiva

    1. = Mild inflammation - slight change in color, slight oedema. No bleeding on probing
    2. = Moderate inflammation-redness, oedema and glazing. Bleeding on probing
    3. = Severe inflammation - marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hue University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H2024/097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will plan to share information when finishing study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings