Knowledge, Attitudes, PracticeNCT04201301
Usage of Stainless Steel Crown on Primary Molars Using Hall Technique
An observational study of Knowledge, Attitudes, Practice, run by Cairo University.
Trial summary
Rationale: Gaining information about the knowledge, practice and attitude regarding hall technique and find out how much the Egyptian dentists use this method for treatment the carious primary teeth. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knowledge, Attitudes, Practice
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 1 Aug 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Egyptian Paediatric in Hospitals and health care units
Who may be able to join
- Egyptian dentists.
- Pediatric dentists ( having PhD).
- Pediatric dentists (having Master degree or studying master degree) .
Who cannot join
- dentists in other dental speciality.
- dental students.
- pediatric dentists who have not enough knowledge about hall technique.
Trial locations and contacts
No sites are listed yet.
Manal Ahmed Mofeed El-Sheikh, professor contact
About this study
Official title: Knowledge, Attitude and Practice (KAP) for Egyptian Pediatric Dentists Regarding Usage of Stainless Steel Crown on Primary Molars Using Hall Technique: A Cross Sectional Study
Rationale: Gaining information about the knowledge, practice and attitude regarding hall technique and find out how much the Egyptian dentists use this method for treatment the carious primary teeth.
Aim of the study: To assess the knowledge, practice and attitude of Egyptian dentists regarding non invasive restorative approach.
Read the detailed description
The first study on the Hall Technique was published in 2006 . It was a retrospective study which analysed the practice records of a general dental practitioner from Scotland, Dr. Norna Hall. Dr. Hall simplified the standard technique to restore primary teeth using preformed SSCs and used it with her patients. This retrospective study involved a total of 978 crowns fitted in 259 children using her novel technique (today known as the Hall Technique). Most crowns were placed when there was clinical evidence of a proximal carious lesion into dentine and marginal ridge breakdown. This study showed the Hall Technique to have comparable outcomes to those achieved with other more conventional restorations.
Since then, growing understanding that caries is essentially a biofilm driven disease rather than an infectious disease, explains why the Hall Technique, and other 'sealing in' carious lesion techniques, are successful. The intervening ten years has seen robust evidence from several randomised control trials that are either completed or underway. These have found the Hall Technique superior to comparator treatments, with success rates (no pain or infection) of 99% (UK study) and 100% (Germany) at one year, 98% and 93% over two years (UK and Germany) and 97% over five years (UK). The Hall Technique is now regarded as one of several biological management options for carious lesions in primary molars.
- Conditions
- Knowledge, Attitudes, Practice
- Medical subject headings
- Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge, practice and attitude of Egyptian Dentists regarding The Hall techniqu
Measuring device: KAP Questionnare Measuring unit: Binary(Yes,No) + Multiple Choice Questions (MCQ).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Feb 2020 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Aug 2020 (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 Knowledge, Attitudes, PracticeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud mohamed El shafie, Cairo University
- Investigators
- faculty of dentistry cairo university, college, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201301
- Sponsor's protocol ID
- metal Crown and primary molars
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Innes 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 28336976Santamaria R, Innes N. Sealing Carious Tissue in Primary Teeth Using Crowns: The Hall Technique. Monogr Oral Sci. 2018;27:113-123. doi: 10.1159/000487835. Epub 2018 May 24.
PubMed 29794469Roberts A, McKay A, Albadri S. The use of Hall technique preformed metal crowns by specialist paediatric dentists in the UK. Br Dent J. 2018 Jan 12;224(1):48-52. doi: 10.1038/sj.bdj.2018.4.
PubMed 29326453
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitude and Practice (KAP) for Egyptian Pediatric Dentists Regarding Usage of Stainless Steel Crown on Primary Molars Using Hall Technique: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT04201301
- Acronym / sponsor ID
- metal Crown and primary molars
- Conditions
- Knowledge, Attitudes, Practice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 17 Dec 2019 (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.
Rationale: Gaining information about the knowledge, practice and attitude regarding hall technique and find out how much the Egyptian dentists use this method for treatment the carious primary teeth.
Aim of the study: To assess the knowledge, practice and attitude of Egyptian dentists regarding non invasive restorative approach.
Detailed description
The first study on the Hall Technique was published in 2006 . It was a retrospective study which analysed the practice records of a general dental practitioner from Scotland, Dr. Norna Hall. Dr. Hall simplified the standard technique to restore primary teeth using preformed SSCs and used it with her patients. This retrospective study involved a total of 978 crowns fitted in 259 children using her novel technique (today known as the Hall Technique). Most crowns were placed when there was clinical evidence of a proximal carious lesion into dentine and marginal ridge breakdown. This study showed the Hall Technique to have comparable outcomes to those achieved with other more conventional restorations.
Since then, growing understanding that caries is essentially a biofilm driven disease rather than an infectious disease, explains why the Hall Technique, and other 'sealing in' carious lesion techniques, are successful. The intervening ten years has seen robust evidence from several randomised control trials that are either completed or underway. These have found the Hall Technique superior to comparator treatments, with success rates (no pain or infection) of 99% (UK study) and 100% (Germany) at one year, 98% and 93% over two years (UK and Germany) and 97% over five years (UK). The Hall Technique is now regarded as one of several biological management options for carious lesions in primary molars.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Egyptian Paediatric in Hospitals and health care units
Key inclusion criteria (3 listed)
- Egyptian dentists.
- Pediatric dentists ( having PhD).
- Pediatric dentists (having Master degree or studying master degree) .
Key exclusion criteria (3 listed)
- dentists in other dental speciality.
- dental students.
- pediatric dentists who have not enough knowledge about hall technique.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
knowledge, practice and attitude of Egyptian Dentists regarding The Hall techniqu
Time frame: baseline
Measuring device: KAP Questionnare Measuring unit: Binary(Yes,No) + Multiple Choice Questions (MCQ).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- 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 29794469Santamaria R, Innes N. Sealing Carious Tissue in Primary Teeth Using Crowns: The Hall Technique. Monogr Oral Sci. 2018;27:113-123. doi: 10.1159/000487835. Epub 2018 May 24.
- Results publication: PubMed 29326453Roberts A, McKay A, Albadri S. The use of Hall technique preformed metal crowns by specialist paediatric dentists in the UK. Br Dent J. 2018 Jan 12;224(1):48-52. doi: 10.1038/sj.bdj.2018.4.
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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.
Manal Ahmed Mofeed El-Sheikh, professor contact
faculty of dentistry cairo university, college study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Knowledge, Attitudes, Practice, 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 3 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 18 Dec 2019. 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 Mahmoud Mohamed El Shafie, Dr (01060977233, Mahmoud.ebead@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge, practice and attitude of Egyptian Dentists regarding The Hall techniqu (time frame: baseline). 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 NCT04201301, 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 18 Dec 2019.