HealthyNCT06594770
Time of Treatment in HALL Technique Vs ART
A study testing Atraumatic Restorative Treatment and Hall technique in people with Healthy, run by Cairo University.
Trial summary
The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are: Does the Hall Technique provide a faster and pain-free treatment compared to ART? How do the outcomes of… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Atraumatic Restorative Treatment and Hall technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: From 4 to 6 years.
- Caries in primary molars within enamel/dentin with vital pulp.
- Healthy children.
- Cooperative children
Who cannot join
- Presence of signs and symptoms of necrosis.
- Root caries.
- History of spontaneous pain.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Time of Treatment of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: a Randomized Clinical Trial
The goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are:
- Does the Hall Technique provide a faster and pain-free treatment compared to ART?
- How do the outcomes of both techniques impact children's acceptance and behavior? Researchers will compare the Hall Technique, which uses preformed metal crowns without caries removal, to Atraumatic Restorative Treatment, which uses hand instruments to selectively remove carious tissue.
Read more
Participants will:
- Receive treatment using either the Hall Technique or ART in a single session.
- Attend follow-up visits to monitor the effectiveness and acceptance of the treatment.
- Complete assessments on their experience and comfort during and after the procedure.
- Conditions
- Healthy
- Being tested
- Atraumatic Restorative Treatment, Hall technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative TreatmentProcedure or surgery
A sharp excavator will be used to remove soft demineralized carious tissue from the patient\'s primary molar 2-The molar will then be restored with capsulated Glass Ionomer in accordance to ART procedure.
3-Each capsule will be mixed for ten seconds and used for restoring teeth isolated by cotton rolls.
4-After the cement is cured, excess material will be removed with an excavator and a carver.
5-The occlusion will be tested for interferences with carbon paper. A layer of varnish coat will be applied to the surface and light-cured for 20 seconds .
Hall techniqueProcedure or surgery
The procedure involves assessing the occlusion, contact points, and tooth shape. If contact points are present, orthodontic separators will be placed between the primary molars to create space for crown fitting, with the child seated upright to maintain airway safety. After 3 to 5 days, the separators will be removed, and loose plaque and debris will be cleared.
The correct crown size will be selected, ensuring it doesn't impinge on adjacent teeth, and will be filled with glass ionomer cement. The child will be instructed to bite down for two minutes to ensure proper seating. Excess cement will be removed, and contacts will be flossed. Any initial occlusal discrepancies are expected to resolve within weeks.
| Study group | Role | What they receive |
|---|---|---|
| ART | Experimental | Not described Receives: Procedure: Atraumatic Restorative Treatment |
| HALL technique | Active comparator | Not described Receives: Procedure: Hall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of treatment
Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.
Measured: during the procedure
Secondary outcomes (4)
Postoperative Pain and discomfort
Immediately after the treatment, any pain and discomfort experienced by the child will be recorded using the Face Pain Scale - revised (FPS-R), which has six numbered faces from 0 to10 The (FPS-R). Each child will be asked to mark the face that reflects her or his experienced pain during the treatment. There is no pain visible on this face [indicating the face on the far left]. As you move from left to right, the faces get progressively more painful until you reach this one, which is incredibly painful [indicating the face on the far right]. The (FPS-R) faces will be scored as 0-2-4-6-8-10.
Measured: immediately after the procedure , 3month ,6 month and 12 month
Child behavior
At the end of the treatment session, the dentist classifies the child's behavior during the treatment according to Venham Behavior Rating Scale is a reliable system for rating behavior of children in the dental setting. ratings will be scored as 0-1-2-3-4-5
Measured: during the procedure
Canine overbite: HT
the canine overbite will be measured only for the hall technique group. The canine overbite will be measured before the procedure using a Boley Gauge, either on the same side or the opposite side if the canine is missing. After assessing tooth shape and occlusion, a stainless-steel crown (SSC) will be partially seated on the tooth with glass ionomer cement. The child will bite on a cotton roll to fully seat the crown, after which excess cement will be removed, and the overbite will be recorded immediately after treatment.
Measured: preoperatively , immediately after the procedure , 3 month , 6 month, 12 month
Child anxiety
At the end of the treatment session, the dentist classifies the child's anxiety during the treatment according to Venham Anxiety Rating Scale is a reliable system for rating anxiety of children in the dental setting. ratings will be scored as 0-1-2-3-4-5
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 posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohamed Khalil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594770
- Sponsor's protocol ID
- Hall technique VS ART
- Status last verified
- Oct 2024
- First submitted
- 6 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time of Treatment of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06594770
- Acronym / sponsor ID
- Hall technique VS ART
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to assess the time of treatment of Hall Technique versus Atraumatic Restorative Technique in the management of carious primary molars. The main questions it aims to answer are:
- Does the Hall Technique provide a faster and pain-free treatment compared to ART?
- How do the outcomes of both techniques impact children's acceptance and behavior? Researchers will compare the Hall Technique, which uses preformed metal crowns without caries removal, to Atraumatic Restorative Treatment, which uses hand instruments to selectively remove carious tissue.
Participants will:
- Receive treatment using either the Hall Technique or ART in a single session.
- Attend follow-up visits to monitor the effectiveness and acceptance of the treatment.
- Complete assessments on their experience and comfort during and after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART | Experimental | Procedure: Atraumatic Restorative Treatment |
| HALL technique | Active comparator | Procedure: Hall technique |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: From 4 to 6 years.
- Caries in primary molars within enamel/dentin with vital pulp.
- Healthy children.
- Cooperative children
Key exclusion criteria (3 listed)
- Presence of signs and symptoms of necrosis.
- Root caries.
- History of spontaneous pain.
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 |
|---|---|---|
| Atraumatic Restorative TreatmentA sharp excavator will be used to remove soft demineralized carious tissue from the patient\'s primary molar 2-The molar will then be restored with capsulated Glass Ionomer in accordance to ART procedure. 3-Each capsule will be mixed for ten seconds and used for restoring teeth isolated by cotton rolls. 4-After the cement is cured, excess material will be removed with an excavator and a carver. 5-The occlusion will be tested for interferences with carbon paper. A layer of varnish coat will be applied to the surface and light-cured for 20 seconds . | Procedure or surgery | ART |
| Hall techniqueThe procedure involves assessing the occlusion, contact points, and tooth shape. If contact points are present, orthodontic separators will be placed between the primary molars to create space for crown fitting, with the child seated upright to maintain airway safety. After 3 to 5 days, the separators will be removed, and loose plaque and debris will be cleared. The correct crown size will be selected, ensuring it doesn't impinge on adjacent teeth, and will be filled with glass ionomer cement. The child will be instructed to bite down for two minutes to ensure proper seating. Excess cement will be removed, and contacts will be flossed. Any initial occlusal discrepancies are expected to resolve within weeks. | Procedure or surgery | HALL technique |
Primary outcome
time of treatment
Time frame: during the procedure
Time will be measured from the start of the procedure till its end using digital chronometer as a device and minutes as a unit.
4 secondary outcomes
Postoperative Pain and discomfort
Time frame: immediately after the procedure , 3month ,6 month and 12 month
Child behavior
Time frame: during the procedure
Canine overbite: HT
Time frame: preoperatively , immediately after the procedure , 3 month , 6 month, 12 month
Child anxiety
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 15 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment and Hall technique in people with Healthy, run by Cairo University.
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 4 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 15 Oct 2024. 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.
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 Doaa mohamed mustafa (00201550150989, doaa.mustafa@dentistry.cu.eud.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of treatment (time frame: during the procedure). 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 15 Oct 2024.