CariesPhase 3NCT04889196
The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars
A Phase 3 study testing Silver diamine fluoride and hall technique in people with Caries, run by Sarah Abdalla Ibrahim Abdalla.
Trial summary
PICO question: In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars? population: children suffering from caries . intervention : silver diamine fluoride. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries
- What is being tested?
- Silver diamine fluoride and hall technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: From 4 to 6 years
- Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease
Who cannot join
- Tooth with signs and symptoms of pulp necrosis
- Tooth with Root caries
- Tooth with Spontaneous pain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars: Randomized Clinical Trial
PICO question:
In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars?
population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome:
Primary outcome:
Gingival health measurement device modified gingival index, measurement unit score(0-1-2)
Secondary outcomes:
- Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)
- Time of Treatment measurement device digital chronometer, measurement unit minutes
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 method
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
- Caries
- Being tested
- Silver diamine fluoride, hall technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver diamine fluorideDrug
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)
hall techniqueDevice
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 method.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The group that have caries in primary molars and treat them with hall technique Receives: Device: hall technique |
| experimental group | Experimental | the group that have caries in primary molars and treat them with silver diamine fluoride (SDF) solution would exert a prevention result in managing early childhood caries ECC Receives: Drug: Silver diamine fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival health
Modified Gingival index (0 = no swelling
- = mild swelling, no bleeding after gentle probing
- = moderate to severe gingival swelling, bleeding after air drying
Measured: up to 1 day
Gingival health
Modified Gingival index (0 = no swelling
- = mild swelling, no bleeding after gentle probing
- = moderate to severe gingival swelling, bleeding after air drying
Measured: at 3 months
Gingival health
Modified Gingival index (0 = no swelling
- = mild swelling, no bleeding after gentle probing
- = moderate to severe gingival swelling, bleeding after air drying
Measured: at 6 months
Secondary outcomes (5)
Oral hygiene
Modified Plaque index(0 = no plaque
- = thin visible plaque, difficult to identify
- = thick visible plaque, easily detected
Measured: up to one day
Oral hygiene
Modified Plaque index(0 = no plaque
- = thin visible plaque, difficult to identify
- = thick visible plaque, easily detected
Measured: at 3 months
Oral hygiene
Modified Plaque index (0 = no plaque
- = thin visible plaque, difficult to identify
- = thick visible plaque, easily detected
Measured: at 6 months
Treatment time
Digital chronometer
Measured: during procedure
Treatment time
Digital chronometer
Measured: during procedure in the second application at 6 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Sep 2021 (estimated)
- Primary completion20 May 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Abdalla Ibrahim Abdalla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Abdalla Ibrahim Abdalla, Cairo University
- Investigators
- sherif B Eltaeil, Prof, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889196
- Sponsor's protocol ID
- 120
- Status last verified
- May 2021
- First submitted
- 1 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
PubMed 31158253
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04889196
- Acronym / sponsor ID
- 120
- Conditions
- Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sarah Abdalla Ibrahim AbdallaUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 17 May 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.
PICO question:
In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars?
population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome:
Primary outcome:
Gingival health measurement device modified gingival index, measurement unit score(0-1-2)
Secondary outcomes:
- Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)
- Time of Treatment measurement device digital chronometer, measurement unit minutes
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 method
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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Device: hall techniqueThe group that have caries in primary molars and treat them with hall technique |
| experimental group | Experimental | Drug: Silver diamine fluoridethe group that have caries in primary molars and treat them with silver diamine fluoride (SDF) solution would exert a prevention result in managing early childhood caries ECC |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: From 4 to 6 years
- Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease
Key exclusion criteria (3 listed)
- Tooth with signs and symptoms of pulp necrosis
- Tooth with Root caries
- Tooth with 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 |
|---|---|---|
| Silver diamine fluoridePrevious 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) | Drug | experimental group |
| hall techniqueThe 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 method. | Device | control group |
Primary outcome
Gingival health
Time frame: up to 1 day
Modified Gingival index (0 = no swelling 1. = mild swelling, no bleeding after gentle probing 2. = moderate to severe gingival swelling, bleeding after air drying
Gingival health
Time frame: at 3 months
Modified Gingival index (0 = no swelling 1. = mild swelling, no bleeding after gentle probing 2. = moderate to severe gingival swelling, bleeding after air drying
Gingival health
Time frame: at 6 months
Modified Gingival index (0 = no swelling 1. = mild swelling, no bleeding after gentle probing 2. = moderate to severe gingival swelling, bleeding after air drying
5 secondary outcomes
Oral hygiene
Time frame: up to one day
Oral hygiene
Time frame: at 3 months
Oral hygiene
Time frame: at 6 months
Treatment time
Time frame: during procedure
Treatment time
Time frame: during procedure in the second application at 6 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Results publication: PubMed 31158253Elamin F, Abdelazeem N, Salah I, Mirghani Y, Wong F. A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan. PLoS One. 2019 Jun 3;14(6):e0217740. doi: 10.1371/journal.pone.0217740. eCollection 2019.
- A randomized clinical trial comparing Hall vs conventional technique in placing preformed metal crowns from Sudan.Link provided by the sponsor.
- 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.
sherif B Eltaeil, Prof study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silver diamine fluoride and hall technique in people with Caries, run by Sarah Abdalla Ibrahim Abdalla.
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 17 May 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sarah A Abdalla, B.S.S (01064038625 ext. 002, sarah.ibrahim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival health (time frame: up to 1 day). The study lists 3 primary outcomes in all. 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 NCT04889196, which also lists 1 linked publication.
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 17 May 2021.