Caries ArrestedNCT04509232
Assessing Parental Acceptance to Silver Diamine Fluoride Staining Before and After Masking the Colour With Glass Ionomer
A study testing Silver diamine fluoride and Silver diamine fluoride and glass ionomer in people with Caries Arrested, run by Dina Bassam Mohamed Ahmed at 1 site in Egypt.
Trial summary
Assessing Parents acceptance for the colour of Silver Diamine Fluoride on their Children anterior and posterior teeth before and after masking its colour with Glass Ionomer. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Arrested
- What is being tested?
- Silver diamine fluoride and Silver diamine fluoride and glass ionomer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2019to 22 Sep 2021
- 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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Uncooperative patients.
- Patients whom their parents refuse or cannot afford the cost of GA surgeries.
- Teeth that are restorable with restoration and doesn't need full coverage.
- Teeth which are free of symptoms of pulpal pathology.
- Children with anterior and posterior carious teeth with minimum of two teeth.
Who cannot join
- Patients whom their parents totally refuse Silver diamine fluoride staining .
- Children suffering from any medical condition that can't be managed in the clinic.
- Children with known allergies to silver products.
- Children with severe forms of hypoplasia .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on Their Child's Anterior and Posterior Teeth Before and After Masking the Colour With Glass Ionomer"
Assessing Parents acceptance for the colour of Silver Diamine Fluoride on their Children anterior and posterior teeth before and after masking its colour with Glass Ionomer.
Read the detailed description
Sample size estimation Sample size estimation was based on the primary outcome of interest The final sample size was 41 children per group (total sample size = 82 children)
Patients will be recruited randomly from outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. A signed informed consent to the parents' and also an insent to child,outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained before the conduction of the study.
All examination procedures will be done by the same operator to ensure standardization.
Moreover, all patients will receive oral health education in regard to dietary and oral hygiene habits.
Excluded carious primary molars will be scheduled to receive the appropriate treatment.
Before applying any procedures medical history for any silver products allergy (SDF allergy) will be assessed by asking the child's parent.
Materials:
38%SDF
Conditioner 3M ESPE
High strength hand mix chemical cure glass ionomer
Patient withdrawal
Patient who don't comply to the oral hygiene given will be excluded from the study.
Patients who are not willing to continue in the study will have the right to quit at any time without loss of any benefits.
Data Management
Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University.
All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times.
Adverse Event Reporting
SDF is not expected to have any adverse effects on healthy subjects, yet failure of treatment, recurrent caries, abcess formation or pulpal affection may be an issue of concern, that will be avoided by the continuous follow up sessions.
Statistical Analysis
Sample size estimation was based on the primary outcome of interest, which is to test whether there's a significant difference in parent satisfaction between the parents of children receiving SDF and those receiving SDF followed by ART restorations. The predicted sample size for comparing parent satisfaction score was found to be 34 children per group (total sample size = 68 children), by assuming an α level of 0.05 and β level of 0.2 (power = 80%). The effect size d was calculated based on the findings of M. Jiang, et al., and the allocation ratio was set at 1. After adjusting for 20% dropout, the final sample size was 41 children per group (total sample size = 82 children). Sample size calculation was performed using G*Power software version 3.1.4 for MS Windows.
- Conditions
- Caries Arrested
- Being tested
- Silver diamine fluoride, Silver diamine fluoride and glass ionomer
- Keywords
- Tertiary prevention, Remineralizing agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver diamine fluorideProcedure or surgery
Also called SDF
Group A
- Excavation of soft carious dentin will be done to minimize the staining.
- The selected teeth should be cleaned, dried and isolated. Vaselline should be applied to surrounding soft tissues to avoid their staining.-
- 38% Silver diamine fluoride will be applied to carious lesions by microbrush
- Apply gentle flow of air until medicament is dry, Try to keep isolated for three minutes,remove excess SDF with cotton pellet to decrease systemic absorption.
After silver diamine fluoride application Assessement of parental acceptance to staining will be done though a 5 point likert scale For anterior and posterior teeth separately .
Silver diamine fluoride and glass ionomerProcedure or surgery
Also called SDF, GIC
- 38% Silver diamine fluoride will be applied by the same protocol as in group A Then Glass Ionomer restoration is applied
- Parental acceptance to staining will be assessed thought 5 point likert scale after application of SDF and once more after application of Glass Ionomer restoration.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | - 38% Silver diamine fluoride will be applied to carious lesions by microbrush on the affected surface application time should be 1 min, Application time will be shorter in very young patients. Receives: Procedure: Silver diamine fluoride |
| group B | Experimental | -38% Silver diamine fluoride will be applied by the same protocol as in group A
Then Glass Ionomer restoration is applied as follows
* Self cure glass ionomer restoration is applied not light cured as light causes oxidation of silver and the filling appears darker.
* Glass ionomer won't be applied immediately after SDF placement it will be applied at time ranging from 2 hours to two days.
* Conditioning of the base of the cavity is done by 3M ESPE conditioner for 10 seconds then rinsing the cavity for 10 to 20 secs.
* Applying High strength hand mix chemical self cure glass ionomer. Receives: Procedure: Silver diamine fluoride and glass ionomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessement of Parental perception and Acceptance
Assessement of Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on their Child's Anterior and Posterior Teeth before and after masking the colour with Glass Ionomer through 5 point likert scale
The format of the five-level Likert scale will be
- Strongly disagree
- Disagree
- Neutral
- Agree
- Strongly agree
Measured: december 2019 to june 2021
Secondary outcomes (1)
protocol for placement of silver diamine fluoride with minimal staining
Applying a protocol for placement of silver diamine fluoride with minimal staining as an alternative modality to general anesthesia for treatment of uncooperative patients in the department of pediatric dentistry Ain shams university.
Measured: december 2019 to june 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start12 Oct 2019
- Primary completion22 Jul 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Caries ArrestedStudies 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
- Model description
- Involves two groups of participants. One group receives
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dina Bassam Mohamed Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Bassam Mohamed Ahmed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509232
- Sponsor's protocol ID
- PED1931M
- Status last verified
- Sep 2021
- First submitted
- 8 Aug 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anil S, Anand PS. Early Childhood Caries: Prevalence, Risk Factors, and Prevention. Front Pediatr. 2017 Jul 18;5:157. doi: 10.3389/fped.2017.00157. eCollection 2017.
PubMed 28770188Clemens J, Gold J, Chaffin J. Effect and acceptance of silver diamine fluoride treatment on dental caries in primary teeth. J Public Health Dent. 2018 Dec;78(1):63-68. doi: 10.1111/jphd.12241. Epub 2017 Jul 27.
PubMed 28749529Innes NP, Manton DJ. Minimum intervention children's dentistry - the starting point for a lifetime of oral health. Br Dent J. 2017 Aug 11;223(3):205-213. doi: 10.1038/sj.bdj.2017.671.
PubMed 28798464Caries-risk Assessment and Management for Infants, Children, and Adolescents. Pediatr Dent. 2018 Oct 15;40(6):205-212. No abstract available.
PubMed 32074889Zhao IS, Gao SS, Hiraishi N, Burrow MF, Duangthip D, Mei ML, Lo EC, Chu CH. Mechanisms of silver diamine fluoride on arresting caries: a literature review. Int Dent J. 2018 Apr;68(2):67-76. doi: 10.1111/idj.12320. Epub 2017 May 21.
PubMed 28542863JUCSF protocol for caries arrest using silver diamine fluoride: rationale, indications, and consent. Br Dent J. 2017 Apr 7;222(7):516. doi: 10.1038/sj.bdj.2017.311.
PubMed 28387277Policy on the Use of Silver Diamine Fluoride for Pediatric Dental Patients. Pediatr Dent. 2018 Oct 15;40(6):51-54. No abstract available.
PubMed 32074849Crystal YO, Niederman R. Evidence-Based Dentistry Update on Silver Diamine Fluoride. Dent Clin North Am. 2019 Jan;63(1):45-68. doi: 10.1016/j.cden.2018.08.011.
PubMed 30447792Burgess JO, Vaghela PM. Silver Diamine Fluoride: A Successful Anticarious Solution with Limits. Adv Dent Res. 2018 Feb;29(1):131-134. doi: 10.1177/0022034517740123.
PubMed 29355424Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.
PubMed 28457477Chu CH, Lee AH, Zheng L, Mei ML, Chan GC. Arresting rampant dental caries with silver diamine fluoride in a young teenager suffering from chronic oral graft versus host disease post-bone marrow transplantation: a case report. BMC Res Notes. 2014 Jan 3;7:3. doi: 10.1186/1756-0500-7-3.
PubMed 24383434Alshammari AF, Almuqrin AA, Aldakhil AM, Alshammari BH, Lopez JNJ. Parental perceptions and acceptance of silver diamine fluoride treatment in Kingdom of Saudi Arabia. Int J Health Sci (Qassim). 2019 Mar-Apr;13(2):25-29.
PubMed 30983942
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on Their Child's Anterior and Posterior Teeth Before and After Masking the Colour With Glass Ionomer"
- ClinicalTrials.gov ID
- NCT04509232
- Acronym / sponsor ID
- PED1931M
- Conditions
- Caries Arrested
- Keywords
- Tertiary prevention, Remineralizing agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Dina Bassam Mohamed AhmedUniversity, hospital or other
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 11 Aug 2020 (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.
Assessing Parents acceptance for the colour of Silver Diamine Fluoride on their Children anterior and posterior teeth before and after masking its colour with Glass Ionomer.
Detailed description
Sample size estimation Sample size estimation was based on the primary outcome of interest The final sample size was 41 children per group (total sample size = 82 children)
Patients will be recruited randomly from outpatient clinic of the Department of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Ain Shams University. A signed informed consent to the parents' and also an insent to child,outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained before the conduction of the study.
All examination procedures will be done by the same operator to ensure standardization.
Moreover, all patients will receive oral health education in regard to dietary and oral hygiene habits.
Excluded carious primary molars will be scheduled to receive the appropriate treatment.
Before applying any procedures medical history for any silver products allergy (SDF allergy) will be assessed by asking the child's parent.
Materials:
38%SDF
Conditioner 3M ESPE
High strength hand mix chemical cure glass ionomer
Patient withdrawal
Patient who don't comply to the oral hygiene given will be excluded from the study.
Patients who are not willing to continue in the study will have the right to quit at any time without loss of any benefits.
Data Management
Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University.
All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times.
Adverse Event Reporting
SDF is not expected to have any adverse effects on healthy subjects, yet failure of treatment, recurrent caries, abcess formation or pulpal affection may be an issue of concern, that will be avoided by the continuous follow up sessions.
Statistical Analysis
Sample size estimation was based on the primary outcome of interest, which is to test whether there's a significant difference in parent satisfaction between the parents of children receiving SDF and those receiving SDF followed by ART restorations. The predicted sample size for comparing parent satisfaction score was found to be 34 children per group (total sample size = 68 children), by assuming an α level of 0.05 and β level of 0.2 (power = 80%). The effect size d was calculated based on the findings of M. Jiang, et al., and the allocation ratio was set at 1. After adjusting for 20% dropout, the final sample size was 41 children per group (total sample size = 82 children). Sample size calculation was performed using G*Power software version 3.1.4 for MS Windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Involves two groups of participants. One group receives
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: Silver diamine fluoride- 38% Silver diamine fluoride will be applied to carious lesions by microbrush on the affected surface application time should be 1 min, Application time will be shorter in very young patients. |
| group B | Experimental | Procedure: Silver diamine fluoride and glass ionomer-38% Silver diamine fluoride will be applied by the same protocol as in group A Then Glass Ionomer restoration is applied as follows * Self cure glass ionomer restoration is applied not light cured as light causes oxidation of silver and the filling appears darker. * Glass ionomer won't be applied immediately after SDF placement it will be applied at time ranging from 2 hours to two days. * Conditioning of the base of the cavity is done by 3M ESPE conditioner for 10 seconds then rinsing the cavity for 10 to 20 secs. * Applying High strength hand mix chemical self cure glass ionomer. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Uncooperative patients.
- Patients whom their parents refuse or cannot afford the cost of GA surgeries.
- Teeth that are restorable with restoration and doesn't need full coverage.
- Teeth which are free of symptoms of pulpal pathology.
- Children with anterior and posterior carious teeth with minimum of two teeth.
Key exclusion criteria (4 listed)
- Patients whom their parents totally refuse Silver diamine fluoride staining .
- Children suffering from any medical condition that can't be managed in the clinic.
- Children with known allergies to silver products.
- Children with severe forms of hypoplasia .
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 fluorideAlso: SDFGroup A * Excavation of soft carious dentin will be done to minimize the staining. * The selected teeth should be cleaned, dried and isolated. Vaselline should be applied to surrounding soft tissues to avoid their staining.- * 38% Silver diamine fluoride will be applied to carious lesions by microbrush * Apply gentle flow of air until medicament is dry, Try to keep isolated for three minutes,remove excess SDF with cotton pellet to decrease systemic absorption. After silver diamine fluoride application Assessement of parental acceptance to staining will be done though a 5 point likert scale For anterior and posterior teeth separately . | Procedure or surgery | group A |
| Silver diamine fluoride and glass ionomerAlso: SDF, GIC* 38% Silver diamine fluoride will be applied by the same protocol as in group A Then Glass Ionomer restoration is applied * Parental acceptance to staining will be assessed thought 5 point likert scale after application of SDF and once more after application of Glass Ionomer restoration. | Procedure or surgery | group B |
Primary outcome
Assessement of Parental perception and Acceptance
Time frame: december 2019 to june 2021
Assessement of Parental Perception and Acceptance of the Utilization of Silver Diamine Fluoride on their Child's Anterior and Posterior Teeth before and after masking the colour with Glass Ionomer through 5 point likert scale The format of the five-level Likert scale will be 1. Strongly disagree 2. Disagree 3. Neutral 4. Agree 5. Strongly agree
1 secondary outcome
protocol for placement of silver diamine fluoride with minimal staining
Time frame: december 2019 to june 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 28770188Anil S, Anand PS. Early Childhood Caries: Prevalence, Risk Factors, and Prevention. Front Pediatr. 2017 Jul 18;5:157. doi: 10.3389/fped.2017.00157. eCollection 2017.
- Background: PubMed 28749529Clemens J, Gold J, Chaffin J. Effect and acceptance of silver diamine fluoride treatment on dental caries in primary teeth. J Public Health Dent. 2018 Dec;78(1):63-68. doi: 10.1111/jphd.12241. Epub 2017 Jul 27.
- Background: PubMed 28798464Innes NP, Manton DJ. Minimum intervention children's dentistry - the starting point for a lifetime of oral health. Br Dent J. 2017 Aug 11;223(3):205-213. doi: 10.1038/sj.bdj.2017.671.
- Background: PubMed 32074889Caries-risk Assessment and Management for Infants, Children, and Adolescents. Pediatr Dent. 2018 Oct 15;40(6):205-212. No abstract available.
- Background: PubMed 28542863Zhao IS, Gao SS, Hiraishi N, Burrow MF, Duangthip D, Mei ML, Lo EC, Chu CH. Mechanisms of silver diamine fluoride on arresting caries: a literature review. Int Dent J. 2018 Apr;68(2):67-76. doi: 10.1111/idj.12320. Epub 2017 May 21.
- Background: PubMed 28387277JUCSF protocol for caries arrest using silver diamine fluoride: rationale, indications, and consent. Br Dent J. 2017 Apr 7;222(7):516. doi: 10.1038/sj.bdj.2017.311.
- Background: PubMed 32074849Policy on the Use of Silver Diamine Fluoride for Pediatric Dental Patients. Pediatr Dent. 2018 Oct 15;40(6):51-54. No abstract available.
- Background: PubMed 30447792Crystal YO, Niederman R. Evidence-Based Dentistry Update on Silver Diamine Fluoride. Dent Clin North Am. 2019 Jan;63(1):45-68. doi: 10.1016/j.cden.2018.08.011.
- Background: PubMed 29355424Burgess JO, Vaghela PM. Silver Diamine Fluoride: A Successful Anticarious Solution with Limits. Adv Dent Res. 2018 Feb;29(1):131-134. doi: 10.1177/0022034517740123.
- Background: PubMed 28457477Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.
- Background: PubMed 24383434Chu CH, Lee AH, Zheng L, Mei ML, Chan GC. Arresting rampant dental caries with silver diamine fluoride in a young teenager suffering from chronic oral graft versus host disease post-bone marrow transplantation: a case report. BMC Res Notes. 2014 Jan 3;7:3. doi: 10.1186/1756-0500-7-3.
- Background: PubMed 30983942Alshammari AF, Almuqrin AA, Aldakhil AM, Alshammari BH, Lopez JNJ. Parental perceptions and acceptance of silver diamine fluoride treatment in Kingdom of Saudi Arabia. Int J Health Sci (Qassim). 2019 Mar-Apr;13(2):25-29.
- 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.
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 Silver diamine fluoride and Silver diamine fluoride and glass ionomer in people with Caries Arrested, run by Dina Bassam Mohamed Ahmed 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 5 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: finished, as of the sponsor's last update on 27 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessement of Parental perception and Acceptance (time frame: december 2019 to june 2021). 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 NCT04509232, which also lists 12 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 27 Sep 2021.