Dental Caries in ChildrenPhase 4NCT04887389
Cariostatic and Remineralizing Effects of Three Different Dental Varnishes
A Phase 4 study testing Nano Silver Fluoride varnish, nano-hydroxyapatite varnish and sodium Fluoride Varnish in people with Dental Caries in Children and Cariostatic Agent, run by Nisreen Ibrahim khan at 1 site in Egypt.
Trial summary
This study is a randomly, controlled, prospective in vivo study. The objective of this study is: To evaluate the cariostatic and re-mineralizing effects of Nano silver fluoride, Nano Hydroxyapatite and sodium fluoride varnishes in caries prevention through: 1. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children, Cariostatic Agent, Resistance, Dental Caries
- What is being tested?
- Nano Silver Fluoride varnish, nano-hydroxyapatite varnish and sodium Fluoride Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Feb 2023
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The inclusion criteria of participated children :
- Age rang 7-10 years.
- Teeth with score 0, 1 or 2 according to (international caries detection and assessment system) ICDAS II index.
- Patient did not receive any re-mineralizing agent other than the regular toothpaste during the past three months.
- No known history of allergy against silver particles or colophonium.
- written informed consent from the parents/guardians.
Who cannot join
- <!-- -->
- Teeth with score 3 or more according to ICDAS II index.
- Partially erupted permanent teeth.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry / Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Cariostatic and Remineralizing Effects of Three Different Dental Varnishes (A Clinical Trial)
This study is a randomly, controlled, prospective in vivo study.
The objective of this study is:
To evaluate the cariostatic and re-mineralizing effects of Nano silver fluoride, Nano Hydroxyapatite and sodium fluoride varnishes in caries prevention through:
- Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria)
- Calcium and fluoride content using enamel biopsy
Read the detailed description
Dental caries is a chronic, multi factorial, transmissible, infectious disease. Caries prevalence in young children in Egypt is very high, and most of the decayed teeth are left untreated, The increase prevalence of dental caries in children globally and in developing countries such as Egypt particularly makes the need for preventive treatment is necessary, one of the ways to prevent dental caries is the application of fluoride which can prevent dental caries by inhibiting demineralization of the crystal structures inside the tooth and enhancing remineralization.
Subsequently over the years various topical fluoride agents have been evolved but NaF (a 22,600 ppm F- preparation) is the most commonly used agent, Based on systematic studies, 5% NaF varnish was more effective in re-mineralizing early enamel caries.
Another anti caries product is a nano-hydroxyapatite (n-HAP), it has antibacterial effect, higher solubility, surface energy and bio activity, there are several studies concluded that 10% (n-HAP) may be optimal for remineralization of early enamel caries Nano-Silver Fluoride (NSF) is a new experimental formulation containing silver nanoparticles, it was introduced by Targino AG et al.(2014) to combat the problem of black discoloration of Silver Diamine Fluoride. It is safe to be used in humans and has effective antimicrobial properties against the pathogens responsible for the development of dental caries.
most of the studies have been evaluated the effectiveness of anti-caries agent in In Vitro and to the best of our knowledge, there are no published studies in Egypt on the effectiveness of these agent. As such, due to the continuous development of new remineralizing agents, research is needed to investigate the newer remineralizing agents under different circumstances. The present study will be carried out to evaluate the efficacy of Nano silver fluoride, Nano Hydroxyapatite and Sodium fluoride varnishes in caries prevention.
- Conditions
- Dental Caries in Children, Cariostatic Agent, Resistance, Dental Caries, Fluoride Varnishes
- Being tested
- Nano Silver Fluoride varnish, nano-hydroxyapatite varnish, sodium Fluoride Varnish
- Keywords
- Dental caries prevention, NSF (nano silver fluoride), n-HAP (Nano hydroxyapatite ), NaF ( Sodium Fluoride), ICDAS II, Enamel biopsy
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano Silver Fluoride varnishDrug
Also called ( NSF)
Nano Silver Fluoride(5%) is a new experimental formulation containing silver nanoparticles, chitosan and fluoride combines preventive and antimicrobial properties. It is a yellow solution and safe to be used in humans
nano-hydroxyapatite varnishDrug
Also called (n-HAP)
nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.
sodium Fluoride VarnishDrug
Also called NaF
Fluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents
| Study group | Role | What they receive |
|---|---|---|
| Group of • Nano Silver Fluoride varnish ( NSF) | Experimental | Selected children will be divided randomly into three groups:
Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =50). Receives: Drug: Nano Silver Fluoride varnish |
| group of Nano hydroxyapatite varnish (n-HAP) | Experimental | Group 2 Children receiving Nano-hydroxyapatite varnish (n = 50) Receives: Drug: nano-hydroxyapatite varnish |
| group of Sodium Fluoride Varnish (NaF) | Experimental | Group 3: Children receiving Sodium Fluoride Varnish (n = 50) Receives: Drug: sodium Fluoride Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
a. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria
After taking the personal data of the participant, dental examination will be conducted by one trained and calibrated examiner under the standard situation including semi-supine position of the subject, good illumination and taking into account all methods of infection control.
Baseline dental examination for all surfaces of included teeth according to ICDAS II was recorded. Only the surfaces with 0, 1 and 2 score will be included in the follow up assessment (Drying of the tooth surface is the key for detecting non-cavitated lesions).
Diagnostic criteria for newly dental caries :
In order to compare the preventive efficacy of the three preventive agent, any change in the baseline recording of score 0, 1, or 2 will be recorded in each visit of all three groups, and an comparison will be made between the mean of tooth surfaces with score 0, 1 or 2 in the baseline visit and during all follow-up visits in each group and after that comparing among all groups.
Measured: 1. All children will be assessed clinically in four visits along one year, at the baseline as well as at 3rd, 6th and 12th month of follow up visit
Enamel biopsy for detecting Calcium and Fluoride content .
The tooth on which the biopsy had to be done will be isolated with the help of cotton rolls and high volume suction to eliminate any chances of saliva contamination. Sticking plaster will be used to cover the tooth to be subjected for biopsy. A 6 mm circular punch will be made in the sticking plaster keeping in mind that it should be present on the buccal surface of molar. A 6 mm non-fluoride containing circular blotting paper will wetted with 5 µL of 30% phosphoric acid and immediately placed on the punched window for 4 s . This filter paper will then transferred to plastic tube which had 0.1 ml of double distilled water pipetted using a micro-pipette. Equal amount of total ionic strength adjustment buffer (TISAB-II) will added using a micropipette to the plastic tube, after which it will be stored for 3 days. After that it will send to laboratory for fluoride and calcium analysis.At the end -fluoride varnish will be applied to the surface.
Measured: Fluoride and calcium content will be evaluated at the baseline as well as at the last follow-up visit through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start1 Aug 2021
- Primary completion1 Sep 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Selected children will be divided randomly into three groups: * Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =39). * Group 2 Children receiving Nano-hydroxyapatite varnish (n = 37). * Group 3: Children receiving Sodium Fluoride Varnish (n = 39) Procedure for material application The application of single drop (0.1 mL) of either (5%) NSF, (10%) n-HAP, (5%) NaF varnishes with a disposable micro-applicator tip for 10 seconds. NSF will be used in a single application and no repetition. While n-HAP, NaF varnishes will be applied each 6 months .
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nisreen Ibrahim khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nisreen Ibrahim khan, Mansoura University
- Investigators
- Salwa A Hegazy, PhD, Principal investigator, Head of Dental Public Health department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887389
- Sponsor's protocol ID
- A07071020
- Status last verified
- Jun 2022
- First submitted
- 5 May 2021
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abbass MMS, Mahmoud SA, El Moshy S, Rady D, AbuBakr N, Radwan IA, Ahmed A, Abdou A, Al Jawaldeh A. The prevalence of dental caries among Egyptian children and adolescences and its association with age, socioeconomic status, dietary habits and other risk factors. A cross-sectional study. F1000Res. 2019 Jan 3;8:8. doi: 10.12688/f1000research.17047.1. eCollection 2019.
PubMed 30854195Azarpazhooh A, Main PA. Fluoride varnish in the prevention of dental caries in children and adolescents: a systematic review. Tex Dent J. 2008 Apr;125(4):318-37. No abstract available.
PubMed 18491761Chu CH, Mei ML, Lo EC. Use of fluorides in dental caries management. Gen Dent. 2010 Jan-Feb;58(1):37-43; quiz 44-5, 79-80.
PubMed 20129891Huang SB, Gao SS, Yu HY. Effect of nano-hydroxyapatite concentration on remineralization of initial enamel lesion in vitro. Biomed Mater. 2009 Jun;4(3):034104. doi: 10.1088/1748-6041/4/3/034104. Epub 2009 Jun 5.
PubMed 19498220Pepla E, Besharat LK, Palaia G, Tenore G, Migliau G. Nano-hydroxyapatite and its applications in preventive, restorative and regenerative dentistry: a review of literature. Ann Stomatol (Roma). 2014 Nov 20;5(3):108-14. eCollection 2014 Jul.
PubMed 25506416Targino AG, Flores MA, dos Santos Junior VE, de Godoy Bene Bezerra F, de Luna Freire H, Galembeck A, Rosenblatt A. An innovative approach to treating dental decay in children. A new anti-caries agent. J Mater Sci Mater Med. 2014 Aug;25(8):2041-7. doi: 10.1007/s10856-014-5221-5. Epub 2014 May 13.
PubMed 24818873
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cariostatic and Remineralizing Effects of Three Different Dental Varnishes (A Clinical Trial)
- ClinicalTrials.gov ID
- NCT04887389
- Acronym / sponsor ID
- A07071020
- Conditions
- Dental Caries in Children, Cariostatic Agent, Resistance, Dental Caries, Fluoride Varnishes
- Keywords
- Dental caries prevention, NSF (nano silver fluoride), n-HAP (Nano hydroxyapatite ), NaF ( Sodium Fluoride), ICDAS II, Enamel biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Nisreen Ibrahim khanUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 14 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.
This study is a randomly, controlled, prospective in vivo study.
The objective of this study is:
To evaluate the cariostatic and re-mineralizing effects of Nano silver fluoride, Nano Hydroxyapatite and sodium fluoride varnishes in caries prevention through:
- Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria)
- Calcium and fluoride content using enamel biopsy
Detailed description
Dental caries is a chronic, multi factorial, transmissible, infectious disease. Caries prevalence in young children in Egypt is very high, and most of the decayed teeth are left untreated, The increase prevalence of dental caries in children globally and in developing countries such as Egypt particularly makes the need for preventive treatment is necessary, one of the ways to prevent dental caries is the application of fluoride which can prevent dental caries by inhibiting demineralization of the crystal structures inside the tooth and enhancing remineralization.
Subsequently over the years various topical fluoride agents have been evolved but NaF (a 22,600 ppm F- preparation) is the most commonly used agent, Based on systematic studies, 5% NaF varnish was more effective in re-mineralizing early enamel caries.
Another anti caries product is a nano-hydroxyapatite (n-HAP), it has antibacterial effect, higher solubility, surface energy and bio activity, there are several studies concluded that 10% (n-HAP) may be optimal for remineralization of early enamel caries Nano-Silver Fluoride (NSF) is a new experimental formulation containing silver nanoparticles, it was introduced by Targino AG et al.(2014) to combat the problem of black discoloration of Silver Diamine Fluoride. It is safe to be used in humans and has effective antimicrobial properties against the pathogens responsible for the development of dental caries.
most of the studies have been evaluated the effectiveness of anti-caries agent in In Vitro and to the best of our knowledge, there are no published studies in Egypt on the effectiveness of these agent. As such, due to the continuous development of new remineralizing agents, research is needed to investigate the newer remineralizing agents under different circumstances. The present study will be carried out to evaluate the efficacy of Nano silver fluoride, Nano Hydroxyapatite and Sodium fluoride varnishes in caries prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Selected children will be divided randomly into three groups: * Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =39). * Group 2 Children receiving Nano-hydroxyapatite varnish (n = 37). * Group 3: Children receiving Sodium Fluoride Varnish (n = 39) Procedure for material application The application of single drop (0.1 mL) of either (5%) NSF, (10%) n-HAP, (5%) NaF varnishes with a disposable micro-applicator tip for 10 seconds. NSF will be used in a single application and no repetition. While n-HAP, NaF varnishes will be applied each 6 months .
| Arm | Type | Receives |
|---|---|---|
| Group of • Nano Silver Fluoride varnish ( NSF) | Experimental | Drug: Nano Silver Fluoride varnishSelected children will be divided randomly into three groups: Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =50). |
| group of Nano hydroxyapatite varnish (n-HAP) | Experimental | Drug: nano-hydroxyapatite varnishGroup 2 Children receiving Nano-hydroxyapatite varnish (n = 50) |
| group of Sodium Fluoride Varnish (NaF) | Experimental | Drug: sodium Fluoride VarnishGroup 3: Children receiving Sodium Fluoride Varnish (n = 50) |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The inclusion criteria of participated children :
Key exclusion criteria (3 listed)
- <!-- -->
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 |
|---|---|---|
| Nano Silver Fluoride varnishAlso: ( NSF)Nano Silver Fluoride(5%) is a new experimental formulation containing silver nanoparticles, chitosan and fluoride combines preventive and antimicrobial properties. It is a yellow solution and safe to be used in humans | Drug | Group of • Nano Silver Fluoride varnish ( NSF) |
| nano-hydroxyapatite varnishAlso: (n-HAP)nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite. | Drug | group of Nano hydroxyapatite varnish (n-HAP) |
| sodium Fluoride VarnishAlso: NaFFluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents | Drug | group of Sodium Fluoride Varnish (NaF) |
Primary outcome
a. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria
Time frame: 1. All children will be assessed clinically in four visits along one year, at the baseline as well as at 3rd, 6th and 12th month of follow up visit
After taking the personal data of the participant, dental examination will be conducted by one trained and calibrated examiner under the standard situation including semi-supine position of the subject, good illumination and taking into account all methods of infection control. Baseline dental examination for all surfaces of included teeth according to ICDAS II was recorded. Only the surfaces with 0, 1 and 2 score will be included in the follow up assessment (Drying of the tooth surface is the key for detecting non-cavitated lesions). Diagnostic criteria for newly dental caries : In order to compare the preventive efficacy of the three preventive agent, any change in the baseline recording of score 0, 1, or 2 will be recorded in each visit of all three groups, and an comparison will be made between the mean of tooth surfaces with score 0, 1 or 2 in the baseline visit and during all follow-up visits in each group and after that comparing among all groups.
Enamel biopsy for detecting Calcium and Fluoride content .
Time frame: Fluoride and calcium content will be evaluated at the baseline as well as at the last follow-up visit through study completion, an average of 1 year"
The tooth on which the biopsy had to be done will be isolated with the help of cotton rolls and high volume suction to eliminate any chances of saliva contamination. Sticking plaster will be used to cover the tooth to be subjected for biopsy. A 6 mm circular punch will be made in the sticking plaster keeping in mind that it should be present on the buccal surface of molar. A 6 mm non-fluoride containing circular blotting paper will wetted with 5 µL of 30% phosphoric acid and immediately placed on the punched window for 4 s . This filter paper will then transferred to plastic tube which had 0.1 ml of double distilled water pipetted using a micro-pipette. Equal amount of total ionic strength adjustment buffer (TISAB-II) will added using a micropipette to the plastic tube, after which it will be stored for 3 days. After that it will send to laboratory for fluoride and calcium analysis.At the end -fluoride varnish will be applied to the surface.
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 2 Apr 2024.
- Results publication: PubMed 30854195Abbass MMS, Mahmoud SA, El Moshy S, Rady D, AbuBakr N, Radwan IA, Ahmed A, Abdou A, Al Jawaldeh A. The prevalence of dental caries among Egyptian children and adolescences and its association with age, socioeconomic status, dietary habits and other risk factors. A cross-sectional study. F1000Res. 2019 Jan 3;8:8. doi: 10.12688/f1000research.17047.1. eCollection 2019.
- Results publication: PubMed 18491761Azarpazhooh A, Main PA. Fluoride varnish in the prevention of dental caries in children and adolescents: a systematic review. Tex Dent J. 2008 Apr;125(4):318-37. No abstract available.
- Results publication: PubMed 20129891Chu CH, Mei ML, Lo EC. Use of fluorides in dental caries management. Gen Dent. 2010 Jan-Feb;58(1):37-43; quiz 44-5, 79-80.
- Results publication: PubMed 19498220Huang SB, Gao SS, Yu HY. Effect of nano-hydroxyapatite concentration on remineralization of initial enamel lesion in vitro. Biomed Mater. 2009 Jun;4(3):034104. doi: 10.1088/1748-6041/4/3/034104. Epub 2009 Jun 5.
- Results publication: PubMed 25506416Pepla E, Besharat LK, Palaia G, Tenore G, Migliau G. Nano-hydroxyapatite and its applications in preventive, restorative and regenerative dentistry: a review of literature. Ann Stomatol (Roma). 2014 Nov 20;5(3):108-14. eCollection 2014 Jul.
- Results publication: PubMed 24818873Targino AG, Flores MA, dos Santos Junior VE, de Godoy Bene Bezerra F, de Luna Freire H, Galembeck A, Rosenblatt A. An innovative approach to treating dental decay in children. A new anti-caries agent. J Mater Sci Mater Med. 2014 Aug;25(8):2041-7. doi: 10.1007/s10856-014-5221-5. Epub 2014 May 13.
- 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.
Salwa A Hegazy, PhD principal investigator
Head of Dental Public Health department
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 Nano Silver Fluoride varnish, nano-hydroxyapatite varnish and sodium Fluoride Varnish in people with Dental Caries in Children and Cariostatic Agent, run by Nisreen Ibrahim khan 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 6 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: finished, as of the sponsor's last update on 2 Apr 2024. 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?
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?
a. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria (time frame: 1. All children will be assessed clinically in four visits along one year, at the baseline as well as at 3rd, 6th and 12th month of follow up visit). The study lists 2 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 NCT04887389, which also lists 6 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 2 Apr 2024.