Paediatric DentistryHallcrownsNCT06545279
The Success Rate and Acceptability of Conventional and Modified Hall Crowns Among Children and Parents
A study testing Hall Crown Technique and Modified Hall Technique in people with Paediatric Dentistry and Dental Caries in Children, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
This is a clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Paediatric Dentistry, Dental Caries in Children, Dental Treatment
- What is being tested?
- Hall Crown Technique and Modified Hall Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteJordan
- Study dates
- 4 Aug 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Fit and healthy (ASA 1) children.
- 4-9 years old children.
- Bilateral ICDAS (1, 2, 3 or 4) class I or II carious lesions on primary molars matched for tooth type.
- Teeth with vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess.
- No tenderness to percussion, or pathological mobility.
- Prior bitewings must be available showing no radiographic evidence of interradicular radiolucency or caries reaching pulp.
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- Contact point is closed.
- Patient has good level of cooperation for the intended procedure.
- Parents consented for their children to be included in the study.
Who cannot join
- Child with systemic illness (ASA 2,3,4).
- Unmatched carious lesions on primary molars.
- Teeth with deep caries (ICDAS score5 or 6) requiring pulp therapy.
- Irreversible pulpitis or pulp necrosis.
- Pathological mobility.
- Prior bitewings are unavailable.
- Contact point is open.
- Patient has poor level of cooperation for the intended procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Success Rate, Child and Parent Acceptance of Modified Hall Crowns Versus Conventional Hall Crowns:A Randomized Clinical Trial
This is a clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. The time interval between both visits will be 1-2 weeks.Patients demographics and pain history will be recorded and pre-operative radiographs will be taken. An observer will assess and record the child's pain perception during each treatment visit. Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure. Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire. Clinical follow up will be conducted at 3,6 and 12 months to assess and compare the success rates of both techniques. Radiographs will be taken at 12 months to evaluate and compare radiographic success.
Read the detailed description
This is a split mouth randomized clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. The time interval between both visits will be 1-2 weeks.Patients demographics and pain history will be recorded and pre-operative bitewings will be taken. An observer (research assistant who will be trained, calibrated, and blinded to the treatment used) will assess and record the child's pain perception during treatment visit. Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure. Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire. Clinical follow up will be conducted at 3,6 and 12 months to assess and compare the success rates of both techniques.Bitewings will be taken at 12 months to assess for crown fit and radiographic pathology.
- Being tested
- Hall Crown Technique, Modified Hall Technique
- Keywords
- Hall crown, Stainless steel crowns, Minimally invasive caries management, biologic caries management, paediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hall Crown TechniqueProcedure or surgery
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation.
Modified Hall TechniqueProcedure or surgery
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation but with interproximal slicing.
| Study group | Role | What they receive |
|---|---|---|
| Hall Crown Technique | Experimental | preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side. Receives: Procedure: Hall Crown Technique |
| Modified Hall Technique | Experimental | preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal but with prior interproximal slicing on other side Receives: Procedure: Modified Hall Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
child's pain perception during intervention recorded by research assistant using sound,eyes and motor (SEM) scale
Measured: during intervention
Child discomfort score
Self-reported Child's discomfort after intervention using Wong-Baker FACES Pain Rating Scale
Measured: immediately following intervention
Child acceptance of treatment
Self-reported child acceptance using questionnaire
Measured: immediately following intervention
Parent acceptance of treatment
Parental acceptance using questionnaire
Measured: immediately following intervention
Rate of clinical success
Absence of pain symptoms/ dental abscess requiring pulp therapy or extraction ,assessed through taking pain history and clinical examination
Measured: 6,12 months
Rate of radiographic Success
Absence of radiographic pathology in the root and the bone in the inter-radicular area.
Measured: 12 months
Secondary outcomes (1)
Time taken for intervention
Time taken for intervention
Measured: during intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Aug 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric DentistryStudies 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
- Sequential
- Model description
- Split mouth randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Areej YA Alqadi, Dr, Principal investigator, Jordan University of Science and TechnologyOla Al-Batayneh, Prof, Study chair, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545279
- Sponsor's protocol ID
- 20230328
- Acronym
- Hallcrowns
- Status last verified
- May 2025
- First submitted
- 9 Jun 2024
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate, Child and Parent Acceptance of Modified Hall Crowns Versus Conventional Hall Crowns:A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06545279
- Acronym / sponsor ID
- Hallcrowns / 20230328
- Keywords
- Hall crown, Stainless steel crowns, Minimally invasive caries management, biologic caries management, paediatric dentistry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Aug 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 is a clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. The time interval between both visits will be 1-2 weeks.Patients demographics and pain history will be recorded and pre-operative radiographs will be taken. An observer will assess and record the child's pain perception during each treatment visit. Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure. Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire. Clinical follow up will be conducted at 3,6 and 12 months to assess and compare the success rates of both techniques. Radiographs will be taken at 12 months to evaluate and compare radiographic success.
Detailed description
This is a split mouth randomized clinical trial that aims to compare the success rate, child and parent acceptance of conventional Hall crown technique (CHT) to modified Hall crown technique (MHT)in treating carious primary molars. Eligible children will receive CHT on one side and MHT on the other side. The time interval between both visits will be 1-2 weeks.Patients demographics and pain history will be recorded and pre-operative bitewings will be taken. An observer (research assistant who will be trained, calibrated, and blinded to the treatment used) will assess and record the child's pain perception during treatment visit. Time taken for each procedure will be recorded by the research assistant each visit prospectively from the moment the child sits on the dental chair till the end of procedure. Parental preference and child acceptance for each procedure will be recorded after treatment is finished using parent and child questionnaire. Clinical follow up will be conducted at 3,6 and 12 months to assess and compare the success rates of both techniques.Bitewings will be taken at 12 months to assess for crown fit and radiographic pathology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split mouth randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Hall Crown Technique | Experimental | Procedure: Hall Crown Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side. |
| Modified Hall Technique | Experimental | Procedure: Modified Hall Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal but with prior interproximal slicing on other side |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Fit and healthy (ASA 1) children.
- 4-9 years old children.
- Bilateral ICDAS (1, 2, 3 or 4) class I or II carious lesions on primary molars matched for tooth type.
- Teeth with vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess.
- No tenderness to percussion, or pathological mobility.
Key exclusion criteria (8 listed)
- Child with systemic illness (ASA 2,3,4).
- Unmatched carious lesions on primary molars.
- Teeth with deep caries (ICDAS score5 or 6) requiring pulp therapy.
- Irreversible pulpitis or pulp necrosis.
- Pathological mobility.
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 Crown Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation. | Procedure or surgery | Hall Crown Technique |
| Modified Hall Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation but with interproximal slicing. | Procedure or surgery | Modified Hall Technique |
Primary outcome
Pain score
Time frame: during intervention
child's pain perception during intervention recorded by research assistant using sound,eyes and motor (SEM) scale
Child discomfort score
Time frame: immediately following intervention
Self-reported Child's discomfort after intervention using Wong-Baker FACES Pain Rating Scale
Child acceptance of treatment
Time frame: immediately following intervention
Self-reported child acceptance using questionnaire
Parent acceptance of treatment
Time frame: immediately following intervention
Parental acceptance using questionnaire
Rate of clinical success
Time frame: 6,12 months
Absence of pain symptoms/ dental abscess requiring pulp therapy or extraction ,assessed through taking pain history and clinical examination
Rate of radiographic Success
Time frame: 12 months
Absence of radiographic pathology in the root and the bone in the inter-radicular area.
1 secondary outcome
Time taken for intervention
Time frame: during intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- 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.
Areej YA Alqadi, Dr principal investigator
Jordan University of Science and Technology
Ola Al-Batayneh, Prof study chair
Jordan University of Science and Technology
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 Crown Technique and Modified Hall Technique in people with Paediatric Dentistry and Dental Caries in Children, run by King Abdullah University Hospital at 1 site in Jordan.
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 9 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2025. 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pain score (time frame: during intervention). The study lists 6 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 11 May 2025.