Early Childhood CariesNCT04737057
Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:
A study testing SDF and Hall technique in people with Early Childhood Caries, run by Cairo University.
Trial summary
This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- SDF and Hall technique
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Sep 2022
- 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
- No healthy volunteers
- Child
Who may be able to join
- Age: From 4 to 6 years
- Caries in primary molars within enamel / dentin without pulp disease
Who cannot join
- Presence of signs and symptoms of necrosis
- Root caries
- Spontaneous pain
Trial locations and contacts
No sites are listed yet.
About this study
This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.
Read the detailed description
Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2
Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)
- Conditions
- Early Childhood Caries
- Being tested
- SDF, Hall technique
- Keywords
- hall technique, Silver diamide fluoride, non invasive technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFProcedure or surgery
Also called Silver Diamine Fluoride
Apply this topical medication through : 1)Dry with a gentle flow of compressed air to decayed tooth surfaces. 2) Bend micro sponge brush to remove excess liquid before application apply SDF directly to only the affected tooth surface. 3) Apply the SDF material 4)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze
Hall techniqueProcedure or surgery
this technique is performed through :1) Orthodontic separator being stretched between two pieces of floss, then placed between the contact points of primary molars (for five days.) 2)The correct size of crown will not impinge on the teeth on either side, and a slight 'spring back' will be felt when the PMC is gently pushed up to (but not through) the contact points and the PMC has been filled with a Riva self-cure capsule cement, extruded cement is quickly wiped away and the child is asked to keep biting on the crown for two minutes, until the cement is set, to prevent 'spring back' of the PMC from the fully seated position
| Study group | Role | What they receive |
|---|---|---|
| Hall Technique | Active comparator | The Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding injections and drilling. It is one of a number of biologically orientated strategies for managing dental decay Receives: Procedure: SDF; Procedure: Hall technique |
| SDF | Experimental | a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children and those with special care needs Receives: Procedure: SDF; Procedure: Hall technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's behavior
evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)
Measured: immediately after the procedure
Secondary outcomes (2)
Canine overbite
measure the canine over bite discrepancy by Boley Gauge by Millimeter
Measured: one year
Arresting caries in SDF
assess caries activity according to International Caries Detection and Assessment System (ICDAS) through Codes 0-1-2-3-4-5-6 ,( higher scores mean a worse outcome)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamiaa Saeed Ahmed Elshiekh, Cairo University
- Investigators
- gihan abo el neil, professor, Study chair, Cairo Universityahmed alkhadem, assistant professor, Study director, Cairo univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737057
- Sponsor's protocol ID
- CairoU1234
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficiency and Child's Behavior of Hall Versus SDF Techniques in the Management of Carious Primary Molar:
- ClinicalTrials.gov ID
- NCT04737057
- Acronym / sponsor ID
- CairoU1234
- Conditions
- Early Childhood Caries
- Keywords
- hall technique, Silver diamide fluoride, non invasive technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 3 Feb 2021 (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 will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.
Detailed description
Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method2
Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hall Technique | Active comparator | Procedure: SDF, Procedure: Hall techniqueThe Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding injections and drilling. It is one of a number of biologically orientated strategies for managing dental decay |
| SDF | Experimental | Procedure: SDF, Procedure: Hall techniquea clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a promising therapeutic agent for managing caries lesions in young children and those with special care needs |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: From 4 to 6 years
- Caries in primary molars within enamel / dentin without pulp disease
Key exclusion criteria (3 listed)
- Presence of signs and symptoms of necrosis
- Root caries
- 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 |
|---|---|---|
| SDFAlso: Silver Diamine FluorideApply this topical medication through : 1)Dry with a gentle flow of compressed air to decayed tooth surfaces. 2) Bend micro sponge brush to remove excess liquid before application apply SDF directly to only the affected tooth surface. 3) Apply the SDF material 4)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze | Procedure or surgery | Hall Technique, SDF |
| Hall techniquethis technique is performed through :1) Orthodontic separator being stretched between two pieces of floss, then placed between the contact points of primary molars (for five days.) 2)The correct size of crown will not impinge on the teeth on either side, and a slight 'spring back' will be felt when the PMC is gently pushed up to (but not through) the contact points and the PMC has been filled with a Riva self-cure capsule cement, extruded cement is quickly wiped away and the child is asked to keep biting on the crown for two minutes, until the cement is set, to prevent 'spring back' of the PMC from the fully seated position | Procedure or surgery | Hall Technique, SDF |
Primary outcome
Child's behavior
Time frame: immediately after the procedure
evaluate the Child's behavior by Frankl scale (FS) through Scores (1-2-3-4) ,(higher scores mean a better outcome)
2 secondary outcomes
Canine overbite
Time frame: one year
Arresting caries in SDF
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Individual participant dataSharing planned: Yes
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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.
gihan abo el neil, professor study chair
Cairo University
ahmed alkhadem, assistant professor study director
Cairo univeristy
Questions about this trial
What is this clinical trial studying?
A study testing SDF and Hall technique in people with Early Childhood Caries, 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 2 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 5 Feb 2021. 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 lamia S El-Sheikh, bachelor (+2 01004733637, lamiaa.alsheikh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's behavior (time frame: immediately after the procedure). 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 5 Feb 2021.