Dental CariesNCT04822233
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.
A study testing Hall Technique (HT), Modified Hall Technique (MHT) and Conventional Technique (CT) in people with Dental Caries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Hall Technique (HT), Modified Hall Technique (MHT) and Conventional Technique (CT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Medically compromised children
- Children with uncooperative behavior during bitewing radiograph process
- Primary molars with irreversible pulpitis
- Teeth with furcation or peri radicular pathologies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Nathanael O Salako, BDS,MSc, 713-486-4141, Nathanael.O.Salako@uth.tmc.edu
Sandra Jung, 713-486-4026, Sandra.Jung@uth.tmc.edu
About this study
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.
- Conditions
- Dental Caries
- Being tested
- Hall Technique (HT), Modified Hall Technique (MHT), Conventional Technique (CT)
- Keywords
- molars
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall Technique (HT)Device
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.
Modified Hall Technique (MHT)Device
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.
Conventional Technique (CT)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Hall Technique (HT) | Experimental | Not described Receives: Device: Hall Technique (HT) |
| Modified Hall Technique (MHT) | Experimental | Not described Receives: Device: Modified Hall Technique (MHT) |
| Conventional Technique (CT) | Active comparator | Not described Receives: Device: Conventional Technique (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success as assessed by number of participants with no coronal or peri-radicular pathology
Measured: 3 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Measured: 6 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Measured: 9 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Measured: 12 months post intervention
Amount of time taken to complete the intervention
Measured: from start of intervention to end of intervention (about 45 minutes to 11/2 hours)
Secondary outcomes (20)
Number of participants with occlusal contact of the molars as assessed by the strip test
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.
Measured: 3 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
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.
Measured: 6 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
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.
Measured: 9 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
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.
Measured: 12 months post intervention
Molar height in occlusion
Measured: 3 months post intervention
Molar height in occlusion
Measured: 6 months post intervention
Molar height in occlusion
Measured: 9 months post intervention
Molar height in occlusion
Measured: 12 months post intervention
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Measured: 3 months post intervention
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Measured: 6 months post intervention
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Measured: 9 months post intervention
Anterior occlusal contact
Over lap of the upper and lower incisors will be measured in millimeters.If incisors are missing, canines will be used.
Measured: 12 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
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
Measured: 3 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
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
Measured: 6 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
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
Measured: 9 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
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
Measured: 12 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
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).
Measured: 3 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
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).
Measured: 6 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
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).
Measured: 9 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
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).
Measured: 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nat Salako BDS(Hons), The University of Texas Health Science Center, Houston
- Investigators
- Nathanael O Salako, BDS,MSc, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822233
- Sponsor's protocol ID
- HSC-DB-20-1247
- Status last verified
- May 2023
- First submitted
- 23 Mar 2021
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04822233
- Acronym / sponsor ID
- HSC-DB-20-1247
- Conditions
- Dental Caries
- Keywords
- molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hall Technique (HT) | Experimental | Device: Hall Technique (HT) |
| Modified Hall Technique (MHT) | Experimental | Device: Modified Hall Technique (MHT) |
| Conventional Technique (CT) | Active comparator | Device: Conventional Technique (CT) |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Medically compromised children
- Children with uncooperative behavior during bitewing radiograph process
- Primary molars with irreversible pulpitis
- Teeth with furcation or peri radicular pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Hall Technique (HT) |
| 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. | Device | Modified Hall Technique (MHT) |
| 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. | Device | Conventional Technique (CT) |
Primary outcome
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time frame: 3 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time frame: 6 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time frame: 9 months post intervention
Success as assessed by number of participants with no coronal or peri-radicular pathology
Time frame: 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)
20 secondary outcomes
Number of participants with occlusal contact of the molars as assessed by the strip test
Time frame: 3 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
Time frame: 6 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
Time frame: 9 months post intervention
Number of participants occlusal contact of the molars as assessed by the strip test
Time frame: 12 months post intervention
Molar height in occlusion
Time frame: 3 months post intervention
Molar height in occlusion
Time frame: 6 months post intervention
Molar height in occlusion
Time frame: 9 months post intervention
Molar height in occlusion
Time frame: 12 months post intervention
Anterior occlusal contact
Time frame: 3 months post intervention
Anterior occlusal contact
Time frame: 6 months post intervention
Anterior occlusal contact
Time frame: 9 months post intervention
Anterior occlusal contact
Time frame: 12 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time frame: 3 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time frame: 6 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time frame: 9 months post intervention
Biofilm around the stainless steel crown as assessed by the Modified Plaque Index
Time frame: 12 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time frame: 3 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time frame: 6 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time frame: 9 months post intervention
Gingival health of the treated tooth as assessed by gingival status score
Time frame: 12 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathanael O Salako, BDS,MSc principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hall Technique (HT), Modified Hall Technique (MHT) and Conventional Technique (CT) in people with Dental Caries, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathanael O Salako, BDS,MSc ((713) 486-4141, Nathanael.O.Salako@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success as assessed by number of participants with no coronal or peri-radicular pathology (time frame: 3 months post intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.