Caries, DentalNCT03872986
Caries Sealing Using Giomer and Glass Ionomer Cement With or Without Silver Diamine Fluoride
A study testing SDF, Giomer and GIC in people with Caries, Dental and Caries Class I, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental, Caries Class I
- What is being tested?
- SDF, Giomer and GIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Feb 2021to 1 Jun 2024
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and parents of the patients who accept to participate and sign the informed consent.
- Patients who have at least four first and/or second primary molars that require class I restorations
- Teeth that have healthy lamina dura and periodontal ligament
- Teeth that have caries lesions not extending to the pulp radiographically
- Patients whose first molar teeth are in occlusion
Who cannot join
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Teeth which need endodontic treatment
- Teeth that have caries more than one surface
- Teeth that are previously restored
- Patients who are not cooperative for the dental procedure
- Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
Show all 9Show fewer
- Patients who have bruxism, skeletal or dental malocclusion
- Teeth that have developmental defects/anomalies or discoloration
- Patients who have allergies to resin based restorative materials
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Zafer C Cehreli, DDS, PhD, +903123052289, zcehreli@gmail.com
Gizem Erbas Unverdi, DDS, PhD, +903123052280, erbasgizem@yahoo.com
- Recruiting
Hacettepe university
Ankara, 06100
Gizem E Unverdi, erbasgizem@yahoo.com
About this study
Official title: Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)
The purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth
Read the detailed description
Restorations will be placed on four primary molar teeth with occlusal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.
Group 1: SDF (Riva Star) + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 2: Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 3: SDF (Riva Star) + GIC (Equia Forte, GC, Japan) Group 4: GIC (Equia Forte, GC, Japan)
The restorations will be evaluated clinically at baseline and 6., 12., 18., 24. months and radiologically at 6., 12. and 24. months. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.
- Conditions
- Caries, Dental, Caries Class I
- Being tested
- SDF, Giomer, GIC
- Keywords
- primary teeth, silver diamine fluoride, caries sealing
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDevice
Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)
GiomerDevice
Beautifil II dental restorative material
GICDevice
Equia forte dental restorative material
| Study group | Role | What they receive |
|---|---|---|
| SDF+Giomer | Experimental | Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material Receives: Device: SDF; Device: Giomer |
| Giomer only | Experimental | Beautifil II dental restorative material Receives: Device: Giomer |
| SDF+GIC | Experimental | Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte Receives: Device: SDF; Device: GIC |
| GIC only | Experimental | Equia forte dental restorative material Receives: Device: GIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The US Public Health Service criteria for secondary caries on restorations
A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries
Measured: 2 years
The US Public Health Service criteria for retention of restorations
Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration
Measured: 2 years
The US Public Health Service criteria for marginal discoloration on restorations
Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction
Measured: 2 years
The US Public Health Service criteria for marginal adaptation on restorations
Alpha: Restoration is fully intact. No explorer catch evident Bravo: Slight explorer catch in no more than 1/3 of margins Charlie: Explorer catch and/or penetration is evident in more than 1/3 of restoration margin
Measured: 2 years
The US Public Health Service criteria for surface roughness on restorations
Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked
Measured: 2 years
The US Public Health Service criteria for anatomical form on restorations
A: No loss on anatomical form of the restoration B: Change in anatomical form but dentin or cement is not expose C: Change in anatomical form that expose dentin or cement
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start4 Feb 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- More trials run by Hacettepe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
- Investigators
- Zafer Cehreli, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872986
- Sponsor's protocol ID
- Caries sealing
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2019
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Caries Sealing Technique on Primary Teeth Using Giomer and Glass Ionomer Cement (GIC) With or Without Silver Diamine Fluoride (SDF)
- ClinicalTrials.gov ID
- NCT03872986
- Acronym / sponsor ID
- Caries sealing
- Conditions
- Caries, Dental, Caries Class I
- Keywords
- primary teeth, silver diamine fluoride, caries sealing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 13 Mar 2019 (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 purpose of this study is to evaluate and compare the clinical performance of Giomer and GIC restorations with and without SDF on caries sealing of primary molar teeth
Detailed description
Restorations will be placed on four primary molar teeth with occlusal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.
Group 1: SDF (Riva Star) + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 2: Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 3: SDF (Riva Star) + GIC (Equia Forte, GC, Japan) Group 4: GIC (Equia Forte, GC, Japan)
The restorations will be evaluated clinically at baseline and 6., 12., 18., 24. months and radiologically at 6., 12. and 24. months. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. Intra-oral photos will be taken directly after treatment and at control appointments.
The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SDF+Giomer | Experimental | Device: SDF, Device: GiomerCombined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Beautifil II restorative material |
| Giomer only | Experimental | Device: GiomerBeautifil II dental restorative material |
| SDF+GIC | Experimental | Device: SDF, Device: GICCombined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) + Equia forte |
| GIC only | Experimental | Device: GICEquia forte dental restorative material |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients and parents of the patients who accept to participate and sign the informed consent.
- Patients who have at least four first and/or second primary molars that require class I restorations
- Teeth that have healthy lamina dura and periodontal ligament
- Teeth that have caries lesions not extending to the pulp radiographically
- Patients whose first molar teeth are in occlusion
Key exclusion criteria (9 listed)
- Patients and parents of the patients who does not accept to participate and sign the informed consent
- Teeth which need endodontic treatment
- Teeth that have caries more than one surface
- Teeth that are previously restored
- Patients who are not cooperative for the dental procedure
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 |
|---|---|---|
| SDFCombined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI) | Device | SDF+GIC, SDF+Giomer |
| GiomerBeautifil II dental restorative material | Device | Giomer only, SDF+Giomer |
| GICEquia forte dental restorative material | Device | GIC only, SDF+GIC |
Primary outcome
The US Public Health Service criteria for secondary caries on restorations
Time frame: 2 years
A:There is no clinical diagnosis of caries C:There is clinical diagnosis of caries
The US Public Health Service criteria for retention of restorations
Time frame: 2 years
Alpha: No loss on the restoration Bravo:Partial loss on the restoration Charlie:Total loss on the restoration
The US Public Health Service criteria for marginal discoloration on restorations
Time frame: 2 years
Alpha: No visual evidence of discoloration Bravo: Slight staining which can be polished away Charlie: Discoloration has penetrated in the pulpal direction
The US Public Health Service criteria for marginal adaptation on restorations
Time frame: 2 years
Alpha: Restoration is fully intact. No explorer catch evident Bravo: Slight explorer catch in no more than 1/3 of margins Charlie: Explorer catch and/or penetration is evident in more than 1/3 of restoration margin
The US Public Health Service criteria for surface roughness on restorations
Time frame: 2 years
Alfa: Enamel-like surface Bravo: Surface rougher than enamel, clinically acceptable Charlie: Surface unacceptably rough / restoration is broken or cracked
The US Public Health Service criteria for anatomical form on restorations
Time frame: 2 years
A: No loss on anatomical form of the restoration B: Change in anatomical form but dentin or cement is not expose C: Change in anatomical form that expose dentin or cement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Zafer Cehreli principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDF, Giomer and GIC in people with Caries, Dental and Caries Class I, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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 9 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 15 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zafer C Cehreli (00905353197969, zcehreli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The US Public Health Service criteria for secondary caries on restorations (time frame: 2 years). The study lists 6 primary outcomes in all. 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 15 Mar 2021.