Decayed Primary MolarsNCT06589622
Major Failure Rate Assessment of Atraumatic Restorative Techniques Versus Hall Technique in the Management of Decayed Primary Molars in Children Aged 4-6 Years Old
A study testing Atraumatic Restorative Treatment and Hall technique in people with Decayed Primary Molars, run by Cairo University at 1 site in Egypt.
Trial summary
This study is designed to compare major failure rate between ART ( excavation of caries with hand instruments and placing glass ionomer restoration without the use of rotary instruments) versus hall technique ( placing a stainless steel crown on the decayed primary molar without prepartion or caries removal) Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Primary Molars
- What is being tested?
- Atraumatic Restorative Treatment and Hall technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: From 4 to 6 years.
- Cooperative children
- Children with no systemic disease, occlusal problems or bad habits.
- Primary molars with vital pulp.
- Class II Caries in primary molars within enamel/dentin.
- Molars in occlusion with the antagonist tooth/teeth.
Show all 10Show fewer
- Teeth with no developmental anomalies.
- Absence of spontaneous pain and tenderness to percussion.
- Absence of any radiolucency in furcation and/or periradicular regions.
- No pathological and internal/external resorption.
Who cannot join
- Presence of signs and symptoms of necrosis (Fistula, abscess, mobility or furcation involvement).
- Root caries.
- History of Spontaneous pain.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo university
Cairo
Cairo univeristy Faculty of dentistry, 00201002159535, Dentmail@dentistry.cu.edu.eg
About this study
Official title: The Major Failures of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: Randomized Clinical Trial
This study is designed to compare major failure rate between ART ( excavation of caries with hand instruments and placing glass ionomer restoration without the use of rotary instruments) versus hall technique ( placing a stainless steel crown on the decayed primary molar without prepartion or caries removal)
- Conditions
- Decayed Primary Molars
- Being tested
- Atraumatic Restorative Treatment, Hall technique
- Keywords
- ART, Hall technique, decayed primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic Restorative TreatmentProcedure or surgery
Caries excavation with hand instruments only and restoration with Glass ionomer filling
Hall techniqueProcedure or surgery
Crown placement without tooth preparation
| Study group | Role | What they receive |
|---|---|---|
| ART | Experimental | Atraumatic restorative technique Receives: Procedure: Atraumatic Restorative Treatment |
| Hall technique | Experimental | Stainless steel crown placement without tooth preparation Receives: Procedure: Hall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major failure
Irreversible pulpitis, Dental abscess or fistula, Restoration loss, Tooth cannot be restored, Tooth fracture.
Measured: 1 year follow up
Secondary outcomes (4)
Canine overbite
Measured: 3 months, 6 months and 1 year follow up
Postoperative pain and discomfort
Face pain scale-revised Its a self report measure of pain intenisty from 0 to 10 with 0 being least painful and 10 being most painful
Measured: Immediately postoperative
Child anxiety
Venham anxiety rating scale is a scale from 0 to 5 assessing the anxiety of children in dental setting with 0 being most relaxed and smiling and 5 being most anxious and out of contact with the reality of the threat.
Measured: Intraoperative
Child behavior
Venham behavior rating scale Its a scale from 0-5 with 0 being total cooperation and 5 being total uncooperation and physical restraint is required.
Measured: Intraoperative
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 start1 Oct 2024 (estimated)
- Primary completion1 Sep 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 Decayed Primary MolarsStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan ahmed ibrahim ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589622
- Sponsor's protocol ID
- ART vs Hall technique
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Major Failures of Hall Technique Versus Atraumatic Restorative Technique in the Management of Carious Primary Molars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06589622
- Acronym / sponsor ID
- ART vs Hall technique
- Conditions
- Decayed Primary Molars
- Keywords
- ART, Hall technique, decayed primary molars
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 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.
This study is designed to compare major failure rate between ART ( excavation of caries with hand instruments and placing glass ionomer restoration without the use of rotary instruments) versus hall technique ( placing a stainless steel crown on the decayed primary molar without prepartion or caries removal)
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 TreatmentAtraumatic restorative technique |
| Hall technique | Experimental | Procedure: Hall techniqueStainless steel crown placement without tooth preparation |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age: From 4 to 6 years.
- Cooperative children
- Children with no systemic disease, occlusal problems or bad habits.
- Primary molars with vital pulp.
- Class II Caries in primary molars within enamel/dentin.
Key exclusion criteria (3 listed)
- Presence of signs and symptoms of necrosis (Fistula, abscess, mobility or furcation involvement).
- 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 TreatmentCaries excavation with hand instruments only and restoration with Glass ionomer filling | Procedure or surgery | ART |
| Hall techniqueCrown placement without tooth preparation | Procedure or surgery | Hall technique |
Primary outcome
Major failure
Time frame: 1 year follow up
Irreversible pulpitis, Dental abscess or fistula, Restoration loss, Tooth cannot be restored, Tooth fracture.
4 secondary outcomes
Canine overbite
Time frame: 3 months, 6 months and 1 year follow up
Postoperative pain and discomfort
Time frame: Immediately postoperative
Child anxiety
Time frame: Intraoperative
Child behavior
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic Restorative Treatment and Hall technique in people with Decayed Primary Molars, run by Cairo University at 1 site in Egypt.
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 10 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 19 Sep 2024. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major failure (time frame: 1 year follow up). 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 Sep 2024.