Dental Caries in ChildrenPhase 4NCT03557996
Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish
A Phase 4 study testing Silver Diamine Fluoride and Sodium Fluoride Varnish in people with Dental Caries in Children, run by Cairo University at 1 site in Egypt.
Trial summary
To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish. Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Silver Diamine Fluoride and Sodium Fluoride Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Jun 2020
- Phase
- Phase 4
- 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 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with carious primary teeth before eruption of permanent teeth
- High caries risk patients with anterior or posterior carious lesions
- Uncooperative children without access to or with difficulty accessing dental care.
Who cannot join
- Children with spontaneous or elicited pain from caries
- Tooth mobility
- Signs of pulpal infection
- Severe medical conditions that would not allow management in the clinic
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Cairo
Fatma KI Abdelgawad, Lecturer, 01006753265, fatmadent@hotmail.com
Yousra M Abdel Rehim, MSc
About this study
Official title: Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial
To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.
Read the detailed description
The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.
Benefit to the patient
- No pain and infection.
- Enhance child cooperation.
- Enhance better patient compliance.
- Decrease cost of dental treatment and may eliminate the need for General Anesthesia.
Benefit to the dentist
- Develop an effective fast easy method to arrest the caries by using SDF.
- Ease of dental treatment.
- Better cooperation with the child.
- The procedure is simple.
- Inexpensive and non-invasive.
- It does not require expensive equipment or support infrastructure, such as pipe water or electricity.
Benefit to the population
- Reduce the harmful impact of oral health problems in preschool children from low income families.
- SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities.
Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.
- Conditions
- Dental Caries in Children
- Being tested
- Silver Diamine Fluoride, Sodium Fluoride Varnish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDrug
Also called SDF
SDF will be applied with a brush
Sodium Fluoride VarnishDrug
Also called NaF varnish
NaF will be applied with a brush
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid Receives: Drug: Silver Diamine Fluoride |
| Group 2 | Active comparator | 5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12 Receives: Drug: Sodium Fluoride Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discoloration
Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)
Measured: 12 months
Secondary outcomes (5)
Investigator reported discoloration
Investigator will report the discoloration occurred to treated teeth (yellow, brown, black) Visual examination
Measured: 12 months
Timing of discoloration
Visual examination at follow up
Measured: 12 months
Caries arrest (dentine texture)
Caries arrest will be assessed through tactile examination (Soft or hard) Tactile examination
Measured: 12 months
Postoperative Pain: Questioning the patient
Questioning the patient and/or the parentBinary (yes or No)
Measured: 12 months
Parental satisfaction: Questioning the parent
Questioning the parent
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patient will receive either silver diamine fluoride or sodium fluoride varnish
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Mohamed, Cairo University
- Investigators
- Nevine G Waly, Professor, Study director, Pediatric Dentistry,Faculty of Dentistry, Cairo UniversityEman S Elmasry, Professor, Study chair, Pediatric Dentistry, Faculty of Dentistry, Cairo UniversityFatma KI Abdelgawad, Lecturer, Study director, Pediatric Dentistry, Faculty of Dentistry, Cairo UniversityYousra M Abdel Rehim, MSc, Principal investigator, Pediatric Dentistry, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557996
- Sponsor's protocol ID
- CEBD-CU-2018-06-2
- Status last verified
- Jun 2018
- First submitted
- 5 Jun 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: outcome results for both groups will be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03557996
- Acronym / sponsor ID
- CEBD-CU-2018-06-2
- Conditions
- Dental Caries in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 15 Jun 2018 (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.
To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.
Detailed description
The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.
Benefit to the patient
- No pain and infection.
- Enhance child cooperation.
- Enhance better patient compliance.
- Decrease cost of dental treatment and may eliminate the need for General Anesthesia.
Benefit to the dentist
- Develop an effective fast easy method to arrest the caries by using SDF.
- Ease of dental treatment.
- Better cooperation with the child.
- The procedure is simple.
- Inexpensive and non-invasive.
- It does not require expensive equipment or support infrastructure, such as pipe water or electricity.
Benefit to the population
- Reduce the harmful impact of oral health problems in preschool children from low income families.
- SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities.
Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- patient will receive either silver diamine fluoride or sodium fluoride varnish
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Silver Diamine Fluoride38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid |
| Group 2 | Active comparator | Drug: Sodium Fluoride Varnish5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with carious primary teeth before eruption of permanent teeth
- High caries risk patients with anterior or posterior carious lesions
- Uncooperative children without access to or with difficulty accessing dental care.
Key exclusion criteria (4 listed)
- Children with spontaneous or elicited pain from caries
- Tooth mobility
- Signs of pulpal infection
- Severe medical conditions that would not allow management in the clinic
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: SDFSDF will be applied with a brush | Drug | Group 1 |
| Sodium Fluoride VarnishAlso: NaF varnishNaF will be applied with a brush | Drug | Group 2 |
Primary outcome
Discoloration
Time frame: 12 months
Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)
5 secondary outcomes
Investigator reported discoloration
Time frame: 12 months
Timing of discoloration
Time frame: 12 months
Caries arrest (dentine texture)
Time frame: 12 months
Postoperative Pain: Questioning the patient
Time frame: 12 months
Parental satisfaction: Questioning the parent
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Individual participant dataSharing planned: Yes. outcome results for both groups will be shared
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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.
Nevine G Waly, Professor study director
Pediatric Dentistry,Faculty of Dentistry, Cairo University
Eman S Elmasry, Professor study chair
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Fatma KI Abdelgawad, Lecturer study director
Pediatric Dentistry, Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Silver Diamine Fluoride and Sodium Fluoride Varnish in people with Dental Caries in Children, run by Cairo University 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 3 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: status not confirmed, as of the sponsor's last update on 18 Jun 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Yousra M Abdel Rehim, MSc (01273335144, yousra.mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discoloration (time frame: 12 months). 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 18 Jun 2018.