A Comparative Study of Hall Technique, Modified Hall Technique and Conventional Stainless-Steel Crown Restorations in the Treatment of Primary Molars With Proximal Caries Lesions.

May 18, 2023 updated by: Nat Salako BDS(Hons), The University of Texas Health Science Center, Houston
The purpose of this study is to compare the effectiveness of the Hall technique and modified Hall technique to the conventional Stainless-Steel Crown restoration in the treatment of primary molars with dentinal caries with or without proximal ridge intact.

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 (Anticipated)

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.
132

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medically fit children
  • Children who exhibit cooperative behavior at initial bitewing radiograph procedure
  • Children with symptom-free or reversible pulpitis restorable first and second primary molars in both arches
  • Teeth with D1 lesions will be included
  • No periapical or furcation pathologies on bite wing radiographs

Exclusion Criteria:

  • Medically compromised children
  • Children with uncooperative behavior during bitewing radiograph process
  • Primary molars with irreversible pulpitis
  • Teeth with furcation or peri radicular pathologies

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: None (Open Label)

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: Hall Technique (HT)
Device: Hall Technique (HT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swap and dispensed in a transport medium for microbial analyses.The preformed metal crown (PMC) will placed without local anesthetic and without crimping or trimming. When the contact points are tight, an orthodontic elastic separator will be placed for 2 hours prior to PMC placement. The PMCs will be cemented with glass ionomer Ketac cem.
Experimental: Modified Hall Technique (MHT)
Device: Modified Hall Technique (MHT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses.This group will in addition to all the procedures for the Hall will have the Caries lesions treated with 30% Silver Diamine Fluoride (SDF) before cementation of the stainless-steel crowns.
Active Comparator: Conventional Technique (CT)
Device: Conventional Technique (CT)
Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses. Conventional occlusal, proximal slicing and when necessary buccal and lingual surfaces will be carried out under local anesthesia and dental dam isolation local anesthesia.The PMC will be trimmed and crimped at the gingival margin to improve the fit, and cemented with Ketac cem.

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
Time Frame
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame: 3 months post intervention
3 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame: 6 months post intervention
6 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame: 9 months post intervention
9 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time Frame: 12 months post intervention
12 months post intervention
Amount of time taken to complete the intervention
Time Frame: from start of intervention to end of intervention (about 45 minutes to 11/2 hours)
from start of intervention to end of intervention (about 45 minutes to 11/2 hours)

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
Number of participants with occlusal contact of the molars as assessed by the strip test
Time Frame: 3 months post intervention
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
3 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
Time Frame: 6 months post intervention
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
6 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
Time Frame: 9 months post intervention
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
9 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
Time Frame: 12 months post intervention
Measured by passing a strip between the contra-lateral upper and lower posterior natural teeth with the child biting into maximum intercuspation. If the strip passes without resistance between teeth anterior or posterior to the SSC there is no occlusal contact.
12 months post intervention
Molar height in occlusion
Time Frame: 3 months post intervention
3 months post intervention
Molar height in occlusion
Time Frame: 6 months post intervention
6 months post intervention
Molar height in occlusion
Time Frame: 9 months post intervention
9 months post intervention
Molar height in occlusion
Time Frame: 12 months post intervention
12 months post intervention
Anterior occlusal contact
Time Frame: 3 months post intervention
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
3 months post intervention
Anterior occlusal contact
Time Frame: 6 months post intervention
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
6 months post intervention
Anterior occlusal contact
Time Frame: 9 months post intervention
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
9 months post intervention
Anterior occlusal contact
Time Frame: 12 months post intervention
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
12 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time Frame: 3 months post intervention
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
3 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time Frame: 6 months post intervention
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
6 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time Frame: 9 months post intervention
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
9 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time Frame: 12 months post intervention
In the Modified Plaque Index, a score of 0 (no plaque), 1 (thin visible plaque, difficult to identify), or 2 (thick visible plaque, easily detected) is assigned
12 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time Frame: 3 months post intervention
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
3 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time Frame: 6 months post intervention
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
6 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time Frame: 9 months post intervention
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
9 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time Frame: 12 months post intervention
Gingival status is assigned a score of 0 (normal gingiva, natural coral pink gingival with no e/o inflammation), 1 (mild inflammation, slight changes in color, slight edema, no bleeding on probing), 2 (moderate inflammation, redness, edema, and glazing, bleeding on probing), or 3 (severe inflammation, marked redness and edema/ulceration/tendency to bleed spontaneously).
12 months post intervention

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.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathanael O Salako, BDS,MSc, The University of Texas Health Science Center, Houston

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 (Anticipated)

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.
June 1, 2023

Primary Completion (Anticipated)

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.
December 1, 2025

Study Completion (Anticipated)

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.
December 1, 2025

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).
March 23, 2021

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.
March 25, 2021

First Posted (Actual)

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.
March 30, 2021

Study Record Updates

Last Update Posted (Actual)

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.
May 19, 2023

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.
May 18, 2023

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.
May 1, 2023

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.
  • HSC-DB-20-1247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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.

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Conditions

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