Dental CariesNCT07136155
Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars.
A study testing Hall Technique and Indirect pulp capping in people with Dental Caries, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal… Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Hall Technique and Indirect pulp capping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteJordan
- Study dates
- 1 Sep 2024to Dec 2026
- 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
- No healthy volunteers
- Child
Who may be able to join
- Fit and healthy.
- Occlusal or proximal carious lesions on primary molars radiographically extending into the inner third or quarter of dentin.
- Vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess.
- No tenderness to percussion, or pathological mobility.
- No radiographic evidence of interradicular/ periapical radiolucency.
- Radiographic evidence of a radiopaque dentin layer between the radiolucent caries lesion and the dental pulp
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- Tooth is restorable.
- Patient has good level of cooperation for the intended procedure.
- Parents consented for their children to be included in the study.
Who cannot join
- Medically compromised children.
- Irreversible pulpitis or pulp necrosis.
- Soft and/or hard tissue pathology.
- Furcal/ periapical pathology.
- Root resorption exceeding one third of the root.
- Pathological mobility.
- Patient has poor level of cooperation for the intended procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars: A Randomized Controlled Trial.
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
Read the detailed description
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
Children aged 4-9 years old presenting with occlusal or proximal carious lesions of primary molars radiographically extending into the inner third or quarter of dentin will be invited to participate in this study. Patients will be randomized into two treatment groups using online block randomization technique (block of 6) and sealed envelope techniques. Time taken for clinical procedure will be recorded by a research assistant prospectively from the time the child sits on the dental chair till the end of procedure. Child pain perception will be recorded during intervention by a blinded research assistant using the Sound Eye Motor scale (SEM). Parental preference and child acceptance for each procedure will be recorded immediately after treatment using parent and child questionnaires. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.
- Conditions
- Dental Caries
- Being tested
- Hall Technique, Indirect pulp capping
- Keywords
- Dental caries, Hall technique, Indirect pulp capping, primary 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 TechniqueProcedure or surgery
preformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side.
Indirect pulp cappingProcedure or surgery
Selective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC).
| 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 Technique |
| Indirect pulp capping | Experimental | Selective caries removal to firm dentin followed by placing RMGI base material and subsequent preformed metal crown (PMC) Receives: Procedure: Indirect pulp capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient pain perception
will be evaluated by an observer (research assistant who will be trained, calibrated, and blinded to the treatment used) and recorded using the Sound, Eyes, and motor scale (SEM);Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort.
Measured: Perioperatively
Rate of Radiographic Success
Absence of radiographic pathology in the root and the bone in the inter-radicular area.
Measured: 6,12 months
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 clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
Measured: 3,6,12 months
Secondary outcomes (1)
Time taken for intervention
Time taken for providing the intervention, measured in minutes
Measured: Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Sep 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136155
- Sponsor's protocol ID
- 414 - 2024
- Other IDs
- 20240506
- Status last verified
- Aug 2025
- First submitted
- 7 May 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect Pulp Capping Versus Hall Crown Technique for the Management of Deep Dentinal Caries of Primary Molars: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07136155
- Acronym / sponsor ID
- 414 - 2024
- Conditions
- Dental Caries
- Keywords
- Dental caries, Hall technique, Indirect pulp capping, primary molars
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (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 randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
Detailed description
This is a randomized clinical trial that aims to compare the clinical and radiographic success of Hall technique (HT) versus Indirect pulp capping (IPC) for the management of deep dentinal caries in primary molars and to compare the child and parent acceptance of HT versus IPC for the management of deep dentinal caries in primary molars.
Children aged 4-9 years old presenting with occlusal or proximal carious lesions of primary molars radiographically extending into the inner third or quarter of dentin will be invited to participate in this study. Patients will be randomized into two treatment groups using online block randomization technique (block of 6) and sealed envelope techniques. Time taken for clinical procedure will be recorded by a research assistant prospectively from the time the child sits on the dental chair till the end of procedure. Child pain perception will be recorded during intervention by a blinded research assistant using the Sound Eye Motor scale (SEM). Parental preference and child acceptance for each procedure will be recorded immediately after treatment using parent and child questionnaires. Clinical and radiographic success, and patient satisfaction will be evaluated at 6 and 12 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hall Crown Technique | Experimental | Procedure: Hall Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side. |
| Indirect pulp capping | Experimental | Procedure: Indirect pulp cappingSelective caries removal to firm dentin followed by placing RMGI base material and subsequent preformed metal crown (PMC) |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Fit and healthy.
- Occlusal or proximal carious lesions on primary molars radiographically extending into the inner third or quarter of dentin.
- Vital pulp with no signs or symptoms of irreversible pulpitis, necrosis, or an abscess.
- No tenderness to percussion, or pathological mobility.
- No radiographic evidence of interradicular/ periapical radiolucency.
Key exclusion criteria (7 listed)
- Medically compromised children.
- Irreversible pulpitis or pulp necrosis.
- Soft and/or hard tissue pathology.
- Furcal/ periapical pathology.
- Root resorption exceeding one third of the root.
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 Techniquepreformed metal crowns (PMCs) cemented with no local anesthesia, caries removal or tooth preparation in one side. | Procedure or surgery | Hall Crown Technique |
| Indirect pulp cappingSelective caries removal to hard dentin followed with G.I base material and subsequent preformed metal crown (PMC). | Procedure or surgery | Indirect pulp capping |
Primary outcome
Patient pain perception
Time frame: Perioperatively
will be evaluated by an observer (research assistant who will be trained, calibrated, and blinded to the treatment used) and recorded using the Sound, Eyes, and motor scale (SEM);Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort.
Rate of Radiographic Success
Time frame: 6,12 months
Absence of radiographic pathology in the root and the bone in the inter-radicular area.
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: 3,6,12 months
Absence of clinical symptoms of spontaneous pain, pain on percussion, pathologic mobility or abscess formation.,assessed through taking pain history and clinical examination.
1 secondary outcome
Time taken for intervention
Time frame: Perioperative/Periprocedural: from the moment the child sits in the chair until the intervention is completed.
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 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Indirect pulp capping in people with Dental Caries, 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 7 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: enrolling by invitation, as of the sponsor's last update on 22 Aug 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?
Patient pain perception (time frame: Perioperatively). 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 22 Aug 2025.