Dental Caries in ChildrenPhase 4NCT03554980
Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth
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
The aim of this study is to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth. 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
- 46 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
- Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta
- Known allergies or sensitivities to dental materials, including SDF
- Inability to return for recall visits
- Refusal of participation from the guardian or parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (A Randomized Clinical Trial)
The aim of this study is to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.
Read the detailed description
Untreated dental decay and poor access to dental care are significant Public health problems for children in the world (Dye et al. 2015 and Horst, 2016). Early childhood caries is a multifactorial, infectious and transmissible dental disease affecting young children . Conventional restorative treatment may fail to reduce the burden of early childhood caries in many parts of the world. Most decayed teeth in preschool children remained unrestored . Consequences of untreated decay in preschool children may include increased risk of future caries in primary and permanent dentition, pain and infections; increased expensive emergency room visits and hospital admissions; increased treatment costs because of extensive decay and the accompanying need for general anesthesia; delayed growth and development; and missed days from school and work .To reduce the burden of caries disease in young children and to avoid possible serious consequences of untreated decay, it is important to identify an effective, low-cost method of treating caries in children at high risk of caries and with limited access to dental care. Silver diamine fluoride (SDF) has been identified as an anticariogenic agent that successfully arrests dental decay and has the potential to address the epidemic of untreated decay in young children
Therefore this study will be conducted to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.
Benefits of the research to the patient:
According to American Academy of Pediatric Dentistry (AAPD), 2017 SDF application is:
- Safe.
- Noninvasive.
- Inexpensive.
- Effective in dental caries management, especially arresting cavitated caries lesions in the primary dentition.
Benefits of the research to the clinician:
According to AAPD, 2017 SDF is:
- Easily performed.
- A promising strategy to manage dental caries in very young children or those who have special needs.
- Doesn't require cooperation from children during dental treatment.
It will improve patient confidence with the dentist
Explanation for choice of comparators:
The use of sodium fluoride is well documented in the literature as successful caries arrestment material. Arrestment proportion of caries for sodium fluoride varnish was found to be 84.4% (NaF) and 85.3% for ( NaF + chlorohexidine mouth wash) .
- 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 at 0,1,3,6, 9 and 12.
SDF is a brush-on liquid. Receives: Drug: Silver Diamine Fluoride |
| Group 2 | Active comparator | 5% sodium fluoride varnish will be applied four times annually and patients 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.
Postoperative Pain
Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)
Measured: 12 months
Secondary outcomes (3)
Parental satisfaction
Parental satisfaction will be assessed through questioning the parent. Binary (yes or no)
Measured: 12 months
Caries arrest (dentin texture) Cries arrest (Dentine texture)
Caries arrest will be assessed through tactile examination (hard or soft). Categorical
Measured: 12 months
Discoloration (yellow, brown, black)
Discoloration will be assessed through visual examination. Categorical
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 posted13 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 according to the allocation ratio
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa A Salmoon, MSc, Cairo University
- Investigators
- Nevine G Waly, Professor, Study chair, Pediatric Dentistry, Faculty of Dentistry, Cairo UniversityEman S Elmasry, Professor, Study director, Pediatric Dentistry, Faculty of Dentistry, Cairo UniversityFatma KI Abdelgawad, Lecturer, Study director, Pediatric Dentistry, Faculty of Dentistry, Cairo UniversityMarwa A Salmoon, MSc, Principal investigator, Pediatric Dentistry, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554980
- Sponsor's protocol ID
- CEBD-CU-2018-06-1
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 14 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 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03554980
- Acronym / sponsor ID
- CEBD-CU-2018-06-1
- Conditions
- Dental Caries in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 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
- 13 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.
The aim of this study is to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.
Detailed description
Untreated dental decay and poor access to dental care are significant Public health problems for children in the world (Dye et al. 2015 and Horst, 2016). Early childhood caries is a multifactorial, infectious and transmissible dental disease affecting young children . Conventional restorative treatment may fail to reduce the burden of early childhood caries in many parts of the world. Most decayed teeth in preschool children remained unrestored . Consequences of untreated decay in preschool children may include increased risk of future caries in primary and permanent dentition, pain and infections; increased expensive emergency room visits and hospital admissions; increased treatment costs because of extensive decay and the accompanying need for general anesthesia; delayed growth and development; and missed days from school and work .To reduce the burden of caries disease in young children and to avoid possible serious consequences of untreated decay, it is important to identify an effective, low-cost method of treating caries in children at high risk of caries and with limited access to dental care. Silver diamine fluoride (SDF) has been identified as an anticariogenic agent that successfully arrests dental decay and has the potential to address the epidemic of untreated decay in young children
Therefore this study will be conducted to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.
Benefits of the research to the patient:
According to American Academy of Pediatric Dentistry (AAPD), 2017 SDF application is:
- Safe.
- Noninvasive.
- Inexpensive.
- Effective in dental caries management, especially arresting cavitated caries lesions in the primary dentition.
Benefits of the research to the clinician:
According to AAPD, 2017 SDF is:
- Easily performed.
- A promising strategy to manage dental caries in very young children or those who have special needs.
- Doesn't require cooperation from children during dental treatment.
It will improve patient confidence with the dentist
Explanation for choice of comparators:
The use of sodium fluoride is well documented in the literature as successful caries arrestment material. Arrestment proportion of caries for sodium fluoride varnish was found to be 84.4% (NaF) and 85.3% for ( NaF + chlorohexidine mouth wash) .
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 according to the allocation ratio
| 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 at 0,1,3,6, 9 and 12. SDF is a brush-on liquid. |
| Group 2 | Active comparator | Drug: Sodium Fluoride varnish5% sodium fluoride varnish will be applied four times annually and patients 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 (8 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
- Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta
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
Postoperative Pain
Time frame: 12 months
Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)
3 secondary outcomes
Parental satisfaction
Time frame: 12 months
Caries arrest (dentin texture) Cries arrest (Dentine texture)
Time frame: 12 months
Discoloration (yellow, brown, black)
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 14 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 chair
Pediatric Dentistry, Faculty of Dentistry, Cairo University
Eman S Elmasry, Professor study director
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 8 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 14 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 Marwa A Salmoon, MSc (01016555055, dr.marwasalmon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (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 14 Jun 2018.