Dental CariesNCT07148401
Parental Satisfaction of Hall Technique for Caries Management in Primary Molars
A study testing Hall technique in people with Dental Caries, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
As a newly introduced technique for caries management in primary teeth, patient-centered outcomes such as parental satisfaction, acceptability of the treatment and child discomfort needs to be investigated about Hall technique. 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2025to 30 Aug 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
- Children with one or more primary molar with class I and class II carious lesions.
- Teeth with no history of pain, or signs of reversible pulpitis
Who cannot join
- Teeth with signs of irreversible pulpitis as spontaneous pain or pain at night.
- Teeth with signs of non-vitality as presence of sinus or fistula or pathologic mobility.
- Teeth with pathological radiographic signs as periapical radiolucency and pathological root resorptions.
- Parental refusal for the use of stainless steel crown
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
National Research Centre
Cairo, 12622
Lamia K Gadallah, 00201001020605, lm.khairy@nrc.sci.eg
Lamia Khairy Gadallah, Researcher
About this study
Official title: Parental and Patient Satisfaction of Hall Technique for Caries Management in Primary Molars
As a newly introduced technique for caries management in primary teeth, patient-centered outcomes such as parental satisfaction, acceptability of the treatment and child discomfort needs to be investigated about Hall technique. Therefore , the aim of our study is to investigate parental and patient satisfaction of Hall technique in managing carious primary molars in children.
Read the detailed description
Children included are those aged from 4 -10 years old. Children with one or more primary molar with class I and class II carious lesions, with no history of pain, or signs of reversible pulpitis .
Patients with signs of irreversible pulpitis as spontaneous pain or pain at night or pathological signs as periapical radiolucency and pathological root resorptions are excluded
Method:
Patient will receive no local anesthesia or tooth preparation. A proper sized preformed stainless-steel crown will be checked first. Then, the crown will be cemented on the tooth using glass ionomer cement The child is instructed to bite on the crown by means of a cotton roll. Excess cement was cleared immediately using a probe after cementation.
Primary outcome:
Parent satisfaction :
Parents satisfaction will be measured by a 5 point Likert scale with five possible answers: strongly agree, agree, neutral, disagree, and strongly disagree.[9]
Patient discomfort:
Discomfort at time of intervention: The Wong-Baker Faces Pain Scale will be used for assessment
Secondary outcomes:
Clinical evaluation will be performed at two-week interval, 6 and 12 months including :
Absence of adverse signs and symptoms of the carious lesion. Crown evaluation including crown retention.
- Conditions
- Dental Caries
- Being tested
- Hall technique
- 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 techniqueDevice
Hall technique for placement of crowns on carious primary molars
| Study group | Role | What they receive |
|---|---|---|
| Hall technique | Active comparator | stainless steel crown is inserted on indicated carious primary molars without tooth preparation Receives: Device: Hall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental satisfaction
Parents satisfaction will be measured by a 5 point Likert scale with five possible answers: strongly agree, agree, neutral, disagree, and strongly disagree
Measured: at time of insertion, 2 weeks , 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start25 Aug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia Mohamed Khairy Gadallah, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148401
- Sponsor's protocol ID
- 18427
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If scientific data with all required details are published so there will be no need to share individual participant data
Publications
Hu S, BaniHani A, Nevitt S, Maden M, Santamaria RM, Albadri S. Hall technique for primary teeth: A systematic review and meta-analysis. Jpn Dent Sci Rev. 2022 Nov;58:286-297. doi: 10.1016/j.jdsr.2022.09.003. Epub 2022 Sep 27.
PubMed 36185501Innes NP, Evans DJ, Bonifacio CC, Geneser M, Hesse D, Heimer M, Kanellis M, Machiulskiene V, Narbutaite J, Olegario IC, Owais A, Araujo MP, Raggio DP, Splieth C, van Amerongen E, Weber-Gasparoni K, Santamaria RM. The Hall Technique 10 years on: Questions and answers. Br Dent J. 2017 Mar 24;222(6):478-483. doi: 10.1038/sj.bdj.2017.273.
PubMed 28336976Innes NP, Evans DJ. Modern approaches to caries management of the primary dentition. Br Dent J. 2013 Jun;214(11):559-66. doi: 10.1038/sj.bdj.2013.529.
PubMed 23744209
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental and Patient Satisfaction of Hall Technique for Caries Management in Primary Molars
- ClinicalTrials.gov ID
- NCT07148401
- Acronym / sponsor ID
- 18427
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 25 Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 29 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.
As a newly introduced technique for caries management in primary teeth, patient-centered outcomes such as parental satisfaction, acceptability of the treatment and child discomfort needs to be investigated about Hall technique. Therefore , the aim of our study is to investigate parental and patient satisfaction of Hall technique in managing carious primary molars in children.
Detailed description
Children included are those aged from 4 -10 years old. Children with one or more primary molar with class I and class II carious lesions, with no history of pain, or signs of reversible pulpitis .
Patients with signs of irreversible pulpitis as spontaneous pain or pain at night or pathological signs as periapical radiolucency and pathological root resorptions are excluded
Method:
Patient will receive no local anesthesia or tooth preparation. A proper sized preformed stainless-steel crown will be checked first. Then, the crown will be cemented on the tooth using glass ionomer cement The child is instructed to bite on the crown by means of a cotton roll. Excess cement was cleared immediately using a probe after cementation.
Primary outcome:
Parent satisfaction :
Parents satisfaction will be measured by a 5 point Likert scale with five possible answers: strongly agree, agree, neutral, disagree, and strongly disagree.[9]
Patient discomfort:
Discomfort at time of intervention: The Wong-Baker Faces Pain Scale will be used for assessment
Secondary outcomes:
Clinical evaluation will be performed at two-week interval, 6 and 12 months including :
Absence of adverse signs and symptoms of the carious lesion. Crown evaluation including crown retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hall technique | Active comparator | Device: Hall techniquestainless steel crown is inserted on indicated carious primary molars without tooth preparation |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with one or more primary molar with class I and class II carious lesions.
- Teeth with no history of pain, or signs of reversible pulpitis
Key exclusion criteria (4 listed)
- Teeth with signs of irreversible pulpitis as spontaneous pain or pain at night.
- Teeth with signs of non-vitality as presence of sinus or fistula or pathologic mobility.
- Teeth with pathological radiographic signs as periapical radiolucency and pathological root resorptions.
- Parental refusal for the use of stainless steel crown
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 techniqueHall technique for placement of crowns on carious primary molars | Device | Hall technique |
Primary outcome
Parental satisfaction
Time frame: at time of insertion, 2 weeks , 6 months, 1 year
Parents satisfaction will be measured by a 5 point Likert scale with five possible answers: strongly agree, agree, neutral, disagree, and strongly disagree
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 29 Aug 2025.
- Background: PubMed 36185501Hu S, BaniHani A, Nevitt S, Maden M, Santamaria RM, Albadri S. Hall technique for primary teeth: A systematic review and meta-analysis. Jpn Dent Sci Rev. 2022 Nov;58:286-297. doi: 10.1016/j.jdsr.2022.09.003. Epub 2022 Sep 27.
- Background: PubMed 28336976Innes NP, Evans DJ, Bonifacio CC, Geneser M, Hesse D, Heimer M, Kanellis M, Machiulskiene V, Narbutaite J, Olegario IC, Owais A, Araujo MP, Raggio DP, Splieth C, van Amerongen E, Weber-Gasparoni K, Santamaria RM. The Hall Technique 10 years on: Questions and answers. Br Dent J. 2017 Mar 24;222(6):478-483. doi: 10.1038/sj.bdj.2017.273.
- Background: PubMed 23744209Innes NP, Evans DJ. Modern approaches to caries management of the primary dentition. Br Dent J. 2013 Jun;214(11):559-66. doi: 10.1038/sj.bdj.2013.529.
- Individual participant dataSharing planned: Undecided. If scientific data with all required details are published so there will be no need to share individual participant data
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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.
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 in people with Dental Caries, run by National Research Centre, Egypt 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 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 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?
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?
Contact Lamia K Gadallah, Researcher (002 01001020605, lm.khairy@nrc.sci.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental satisfaction (time frame: at time of insertion, 2 weeks , 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07148401, which also lists 3 linked publications.
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 29 Aug 2025.