Dental CariesPhase 4NCT04777968
Evaluation Of Fluoride Uptake By Dentine Following Silver Diamine Fluoride Under Resin Modified Glass Ionomer Restoration In Carious Primary Molars
A Phase 4 study testing Silver diamine fluoride in people with Dental Caries, run by Cairo University at 2 sites in Egypt.
Trial summary
Dental caries is one of the most common oral diseases of childhood and is considered as a major public health problem especially in areas with poor access to dental care. In a recent cross sectional study carried out in Egypt on 1000 child aged from 3-6 years, it was found that 61.4% of these children had dental… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Silver diamine fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Aug 2020to 1 Feb 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- • Carious primary extracted molars.
- Presence of occlusal or proximal caries.
- Caries extending to dentine.
Who cannot join
- • Presence of restorations.
- Presence of pit and fissure sealant.
- Hypolpastic teeth.
- Severly destructed teeth. Thirty two teeth were collected, but only 20 teeth were eligible according to the inclusion and exclusion criteria. Teeth were then stored in distilled water
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University
Cairo, 0022
Faculty of Dentistry, Cairo University
Cairo, 0022
About this study
Official title: Evaluation Of Fluoride Uptake By Dentine Following Pretreatment With Silver Diamine Fluoride And Potassium Iodide Under Resin Modified Glass Ionomer Restoration Versus Resin Modified Glass Ionomer Restoration Alone In Carious Primary Molars: (In Vitro Study)
Dental caries is one of the most common oral diseases of childhood and is considered as a major public health problem especially in areas with poor access to dental care. In a recent cross sectional study carried out in Egypt on 1000 child aged from 3-6 years, it was found that 61.4% of these children had dental caries. In order to avoid serious complications of untreated dental caries such as pain, infections, emergency visits and possibly hospitalization , an effective low cost treatment should be identified particularly in areas with poor dental access.
Studies have proven that silver diamine fluoride (SDF) is a topical fluoride that has the ability to effectively arrest and prevent dental caries.
Read the detailed description
It was concluded that fluoride uptake into dentine from conventional GI restorations was not affected in the presence of SDF and KI. It was also mentioned that the results may be different if conditioning is applied not etching and recommended this for future investigation.
Aim: Therefore, the aim of this study is to determine whether carious primary molars treated with SDF and Potassium iodide (KI) prior to placing resin modified glass ionomer (RMGI) restorations will affect the fluoride uptake into primary dentine or not.
Study Setting:
- The study was conducted in Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Cairo University, Egypt.
- Energy Dispersive X-ray analysis with Scanning Electron Microscope (SEM/EDX) measurement analysis was conducted at the National Research Center (NRC), Egypt.
Freshly extracted discarded primary molars were collected from outpatient clinic of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University at the end of every day.
- Teeth were then sectioned through the center of the carious lesion mesiodistally using a slow-speed cutting saw with coolant (Isomet 4000, USA) forming two similar halves, so that the 20 molars were sectioned to 40 halves.
- Each tooth was placed in a separate container with its 2 halves.
- Teeth containers were then randomly allocated either to the control or intervention group.
Control Group: One half empty and the other half with Resin Modified Glass Ionmer (RMGI) only.
Intervention Group : One half empty and the other half SDF+KI+RMGI
- After dehydration, teeth were mounted on stubs using double-sided carbon tape, and sputter coated with gold for 20 s using a Turbo molecular pumped coater (QUORUM 150T ES, Laughton, United Kingdom) .
- Teeth were then placed in SEM/EDX for fluoride measurement by weight percentage.
Data showed parametric distribution so; it was represented by mean and standard deviation (SD) values. Independent and paired t-tests were used for inter and intragroup comparisons respectively. The significance level was set at p ≤0.05 within all tests. Statistical analysis was performed with R statistical analysis software version 4.0.3 for windows (R Core Team, 2020).
- Conditions
- Dental Caries
- Being tested
- Silver diamine fluoride
- Keywords
- Silver Diamine Fluoride, Resin Modified Glass Ionomer, Fluoride Uptake, Carious primary teeth
- Medical subject headings
- Dental Caries
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 and KI
a layer of 38% SDF solution was topically applied to the cavity using a micro brush, immediately followed by a saturated Potassium Iodide KI solution using a micro brush also, then a creamy white precipitate was immediately formed, KI was applied until the white precipitate turned clear.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (A) : RMGI restoration without SDF and KI. | No intervention | • RMGI restoration without SDF and KI. |
| Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration. | Experimental | • Pretreatment with SDF and KI prior to RMGI restoration. Receives: Drug: Silver diamine fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoride uptake into dentine
Fluoride weight percent in dentin under Resin Modified Glass Ionomer Restoration in primary molars
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Aug 2020
- Primary completion1 Dec 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Extracted Discarded Primary Molars divided into CONTROL Group \& INTERVENTIONAL Group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Dr. Rania Abdallah Nasr, Cairo University
- Investigators
- Rania Nasr, Assoc. Prof., Principal investigator, Faculty of Dentistry, Cairo University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777968
- Sponsor's protocol ID
- 19739
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol and Abstract
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Fluoride Uptake By Dentine Following Pretreatment With Silver Diamine Fluoride And Potassium Iodide Under Resin Modified Glass Ionomer Restoration Versus Resin Modified Glass Ionomer Restoration Alone In Carious Primary Molars: (In Vitro Study)
- ClinicalTrials.gov ID
- NCT04777968
- Acronym / sponsor ID
- 19739
- Conditions
- Dental Caries
- Keywords
- Silver Diamine Fluoride, Resin Modified Glass Ionomer, Fluoride Uptake, Carious primary teeth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 2 Mar 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.
Dental caries is one of the most common oral diseases of childhood and is considered as a major public health problem especially in areas with poor access to dental care. In a recent cross sectional study carried out in Egypt on 1000 child aged from 3-6 years, it was found that 61.4% of these children had dental caries. In order to avoid serious complications of untreated dental caries such as pain, infections, emergency visits and possibly hospitalization , an effective low cost treatment should be identified particularly in areas with poor dental access.
Studies have proven that silver diamine fluoride (SDF) is a topical fluoride that has the ability to effectively arrest and prevent dental caries.
Detailed description
It was concluded that fluoride uptake into dentine from conventional GI restorations was not affected in the presence of SDF and KI. It was also mentioned that the results may be different if conditioning is applied not etching and recommended this for future investigation.
Aim: Therefore, the aim of this study is to determine whether carious primary molars treated with SDF and Potassium iodide (KI) prior to placing resin modified glass ionomer (RMGI) restorations will affect the fluoride uptake into primary dentine or not.
Study Setting:
- The study was conducted in Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry, Cairo University, Egypt.
- Energy Dispersive X-ray analysis with Scanning Electron Microscope (SEM/EDX) measurement analysis was conducted at the National Research Center (NRC), Egypt.
Freshly extracted discarded primary molars were collected from outpatient clinic of Pediatric Dentistry Department, Faculty of Dentistry, Cairo University at the end of every day.
- Teeth were then sectioned through the center of the carious lesion mesiodistally using a slow-speed cutting saw with coolant (Isomet 4000, USA) forming two similar halves, so that the 20 molars were sectioned to 40 halves.
- Each tooth was placed in a separate container with its 2 halves.
- Teeth containers were then randomly allocated either to the control or intervention group.
Control Group: One half empty and the other half with Resin Modified Glass Ionmer (RMGI) only.
Intervention Group : One half empty and the other half SDF+KI+RMGI
- After dehydration, teeth were mounted on stubs using double-sided carbon tape, and sputter coated with gold for 20 s using a Turbo molecular pumped coater (QUORUM 150T ES, Laughton, United Kingdom) .
- Teeth were then placed in SEM/EDX for fluoride measurement by weight percentage.
Data showed parametric distribution so; it was represented by mean and standard deviation (SD) values. Independent and paired t-tests were used for inter and intragroup comparisons respectively. The significance level was set at p ≤0.05 within all tests. Statistical analysis was performed with R statistical analysis software version 4.0.3 for windows (R Core Team, 2020).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Extracted Discarded Primary Molars divided into CONTROL Group \& INTERVENTIONAL Group
| Arm | Type | Receives |
|---|---|---|
| Control Group (A) : RMGI restoration without SDF and KI. | No intervention | –• RMGI restoration without SDF and KI. |
| Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration. | Experimental | Drug: Silver diamine fluoride• Pretreatment with SDF and KI prior to RMGI restoration. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- • Carious primary extracted molars.
Key exclusion criteria (4 listed)
- • Presence of restorations.
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: SDF and KIa layer of 38% SDF solution was topically applied to the cavity using a micro brush, immediately followed by a saturated Potassium Iodide KI solution using a micro brush also, then a creamy white precipitate was immediately formed, KI was applied until the white precipitate turned clear. | Drug | Intervention Group (B): Pretreatment with SDF and KI prior to RMGI restoration. |
Primary outcome
Fluoride uptake into dentine
Time frame: 2 weeks
Fluoride weight percent in dentin under Resin Modified Glass Ionomer Restoration in primary molars
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 8 Mar 2021.
- Individual participant dataSharing planned: No. Protocol and Abstract
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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.
Rania Nasr, Assoc. Prof. principal investigator
Faculty of Dentistry, Cairo University, Egypt
2 sites 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 in people with Dental Caries, run by Cairo University at 2 sites 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: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fluoride uptake into dentine (time frame: 2 weeks). 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 8 Mar 2021.