CariesPhase 1/2NCT05301439
Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions
A Phase 1/2 study testing Restoration with Resin, Hall Technique and Conventional Steel Crown in people with Caries, run by University of Nove de Julho.
Trial summary
Despite preventive treatments and the promotion of oral health, dental caries is one of the most prevalent chronic diseases in the population and treatment of caries lesions in deciduous teeth is a fundamental procedure aimed at increasing the resistance of the remaining tooth structure to preserve the permanent… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Restoration with Resin, Hall Technique and Conventional Steel Crown
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 20 Jun 2024
- Phase
- Phase 1/2
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy child, without systemic changes;
- Good behavior;
- Clinically, present at least two deciduous molars with caries in dentin involving more than three surfaces, with vision and direct access, without signs and symptoms of pulp involvement.
Who cannot join
- Children with any serious systemic disorder;
- Lack of cooperation.
- Clinically present at least one deciduous molar with carious lesion in the dentin involving signs and symptoms of pulpal involvement.
About this study
Official title: Controlled Clinical Trial Of The Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions. Follow Up Of 12 Months.
Despite preventive treatments and the promotion of oral health, dental caries is one of the most prevalent chronic diseases in the population and treatment of caries lesions in deciduous teeth is a fundamental procedure aimed at increasing the resistance of the remaining tooth structure to preserve the permanent dentition. The present study aims to make a clinical evaluation of the Hall Technique compared to direct restorations with universal adhesives and bulk fill resins in large destruction of deciduous teeth. 90 children between 5 and 10 years old, healthy, of both sexes, without distinction of race, enrolled in the clinics of Universidade Metropolitana de Santos-UNIMES will be selected. The in-office treatments will be carried out by a trained researcher, according to the manufacturer's instructions for each material and scientific evidence on the respective topic. Participants will be divided into 03 groups according to the proposed treatments. Group 1 - Universal adhesive restorative procedure + condensable bulk fill resin; Group 2 - Hall Technique with Shofu steel crowns and Group 3 - Steel crown with conventional technique. The evaluated outcomes will be: effectiveness of the technique and longevity of the restorations.
- Conditions
- Caries
- Being tested
- Restoration with Resin, Hall Technique, Conventional Steel Crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration with ResinProcedure or surgery
Prophylaxis with prophylactic paste and rubber cup. Relative isolation (lip retractor, cotton roll and saliva sucker). Selective removal of carious tissue with dentin spoons at the dentin-enamel junction.
Cleaning the cavity with water. Application of the Universal Adhesive System (Shofu). Excess removal. Application of a new layer of adhesive system. Light rubbing and excess removal. Photoactivation - 20s. Insert Bulk Fill Resin (Shofu) in 4mm increments. Photoactivation for 20". Preservation. Clinical and radiographic control at 1, 3, 6 and 12 months.
Hall TechniqueProcedure or surgery
Prophylaxis with prophylactic paste and rubber cup. Relative isolation (lip retractor, cotton roll and saliva sucker). Clinical evaluation through inspection of the texture of the remaining dentin with a rounded exploratory probe.
Cleaning the cavity with water. Take drying. Proof of the steel crown. Relative isolation. Filling the inner part of the crown with bioactive resin cement or glass ionomer cement for cementation.
Clinical and radiographic control at 1, 3, 6 and 12 months.
Conventional Steel CrownProcedure or surgery
- Prophylaxis;
- Relative isolation;
- The preparation of the tooth will be performed conventionally with reduction of the occlusal, mesial and distal surface of 1 to 1.5 mm and selective removal of the decayed tissue;
- Cleaning the cavity with water;
- Slight drying;
- Trial of steel crown;
- Relative isolation;
- Filling the inner part of the crown with bioactive resin cement or glass ionomer cement for cementation.
- Clinical and radiographic control at 1, 3, 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Restoration Group | Experimental | Participants in this group will receive the universal adhesive restorative procedure combined with condensable bulk fill resin, for the restoration of the cavited teeth. Receives: Procedure: Restoration with Resin |
| Hall Technique Group | Experimental | Participants in this group will receive the Hall Technique with steel crowns for the restoration of the cavited teeth. Receives: Procedure: Hall Technique |
| Steel Crown with Conventional Technique Group | Experimental | Participants in this group will receive steel crowns with conventional technique for the restoration of the cavited teeth. Receives: Procedure: Conventional Steel Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Longevity Of Restorations
Steel restorations and crowns will be classified according to the criteria in the following scores: FDI criterion (clinically very good, clinically good, clinically sufficient/satisfactory, clinically unsatisfactory, clinically poor).
Measured: Three, 6 and 12 months after treatment.
Secondary outcomes (4)
Changes in the biofilm index
The presence of biofilm will be evaluated through the Simplified Oral Hygiene Index (OHI-S).
Measured: Baseline, 3, 6, and 12 months after treatment.
Changes in Salivary PH
Participants will be asked to spit into a collection pot, in which the pH will be measured with measuring stripes.
Measured: Baseline, 6, and 12 months after treatment.
Changes in The Presence of Caries Lesions
A clinical evaluation in the search of carious lesions will be performed.
Measured: Baseline, 6, and 12 months after treatment.
Technique Perfomance Time Duration
To take the time, a previously calibrated digital stopwatch will be used.
Measured: During the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start20 Jun 2023 (estimated)
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Metropolitana de Santos
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301439
- Sponsor's protocol ID
- HallTechnique
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trial Of The Use Of Hall Technique In Deciduous Molars Affected By Extensive Caries Lesions. Follow Up Of 12 Months.
- ClinicalTrials.gov ID
- NCT05301439
- Acronym / sponsor ID
- HallTechnique
- Conditions
- Caries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Universidade Metropolitana de Santos
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 29 Mar 2022 (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.
Despite preventive treatments and the promotion of oral health, dental caries is one of the most prevalent chronic diseases in the population and treatment of caries lesions in deciduous teeth is a fundamental procedure aimed at increasing the resistance of the remaining tooth structure to preserve the permanent dentition. The present study aims to make a clinical evaluation of the Hall Technique compared to direct restorations with universal adhesives and bulk fill resins in large destruction of deciduous teeth. 90 children between 5 and 10 years old, healthy, of both sexes, without distinction of race, enrolled in the clinics of Universidade Metropolitana de Santos-UNIMES will be selected. The in-office treatments will be carried out by a trained researcher, according to the manufacturer's instructions for each material and scientific evidence on the respective topic. Participants will be divided into 03 groups according to the proposed treatments. Group 1 - Universal adhesive restorative procedure + condensable bulk fill resin; Group 2 - Hall Technique with Shofu steel crowns and Group 3 - Steel crown with conventional technique. The evaluated outcomes will be: effectiveness of the technique and longevity of the restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Restoration Group | Experimental | Procedure: Restoration with ResinParticipants in this group will receive the universal adhesive restorative procedure combined with condensable bulk fill resin, for the restoration of the cavited teeth. |
| Hall Technique Group | Experimental | Procedure: Hall TechniqueParticipants in this group will receive the Hall Technique with steel crowns for the restoration of the cavited teeth. |
| Steel Crown with Conventional Technique Group | Experimental | Procedure: Conventional Steel CrownParticipants in this group will receive steel crowns with conventional technique for the restoration of the cavited teeth. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy child, without systemic changes;
- Good behavior;
- Clinically, present at least two deciduous molars with caries in dentin involving more than three surfaces, with vision and direct access, without signs and symptoms of pulp involvement.
Key exclusion criteria (3 listed)
- Children with any serious systemic disorder;
- Lack of cooperation.
- Clinically present at least one deciduous molar with carious lesion in the dentin involving signs and symptoms of pulpal involvement.
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 |
|---|---|---|
| Restoration with ResinProphylaxis with prophylactic paste and rubber cup. Relative isolation (lip retractor, cotton roll and saliva sucker). Selective removal of carious tissue with dentin spoons at the dentin-enamel junction. Cleaning the cavity with water. Application of the Universal Adhesive System (Shofu). Excess removal. Application of a new layer of adhesive system. Light rubbing and excess removal. Photoactivation - 20s. Insert Bulk Fill Resin (Shofu) in 4mm increments. Photoactivation for 20". Preservation. Clinical and radiographic control at 1, 3, 6 and 12 months. | Procedure or surgery | Restoration Group |
| Hall TechniqueProphylaxis with prophylactic paste and rubber cup. Relative isolation (lip retractor, cotton roll and saliva sucker). Clinical evaluation through inspection of the texture of the remaining dentin with a rounded exploratory probe. Cleaning the cavity with water. Take drying. Proof of the steel crown. Relative isolation. Filling the inner part of the crown with bioactive resin cement or glass ionomer cement for cementation. Clinical and radiographic control at 1, 3, 6 and 12 months. | Procedure or surgery | Hall Technique Group |
| Conventional Steel Crown* Prophylaxis; * Relative isolation; * The preparation of the tooth will be performed conventionally with reduction of the occlusal, mesial and distal surface of 1 to 1.5 mm and selective removal of the decayed tissue; * Cleaning the cavity with water; * Slight drying; * Trial of steel crown; * Relative isolation; * Filling the inner part of the crown with bioactive resin cement or glass ionomer cement for cementation. * Clinical and radiographic control at 1, 3, 6 and 12 months. | Procedure or surgery | Steel Crown with Conventional Technique Group |
Primary outcome
Changes in the Longevity Of Restorations
Time frame: Three, 6 and 12 months after treatment.
Steel restorations and crowns will be classified according to the criteria in the following scores: FDI criterion (clinically very good, clinically good, clinically sufficient/satisfactory, clinically unsatisfactory, clinically poor).
4 secondary outcomes
Changes in the biofilm index
Time frame: Baseline, 3, 6, and 12 months after treatment.
Changes in Salivary PH
Time frame: Baseline, 6, and 12 months after treatment.
Changes in The Presence of Caries Lesions
Time frame: Baseline, 6, and 12 months after treatment.
Technique Perfomance Time Duration
Time frame: During the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Restoration with Resin, Hall Technique and Conventional Steel Crown in people with Caries, run by University of Nove de Julho.
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 3 inclusion and 3 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 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Longevity Of Restorations (time frame: Three, 6 and 12 months after treatment.). 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 21 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.