Carious LesionNCT05485272
Clinical Evaluation of SDF Combined With KI Versus SDF in Management of Class I Carious Lesions
A study testing Silver Diamine Fluoride combined with Potassium Iodide., Silver Diamine Fluoride. and High-Viscosity Glass Ionomer. in people with Carious Lesion, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate the clinical performance of High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) in deep class I carious lesions, over a period of one year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Lesion
- What is being tested?
- Silver Diamine Fluoride combined with Potassium Iodide., Silver Diamine Fluoride. and High-Viscosity Glass Ionomer.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 2 Mar 2023
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with deep class I carious lesions in molars, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin).
- Adults males or females.
- Age: 18-40 years old.
- Good Oral hygiene.
- Co-operative patients, approving to participate in the study.
- Teeth planned to be restored should be vital.
- Presence of favorable occlusion.
Who cannot join
- Patients having severe systemic diseases, allergies, or adverse medical histories.
- Patients complaining of sever or active periodontal disease.
- Lack of compliance.
- Teeth diagnosed with irreversible pulpitis.
- Non vital teeth.
- Heavy occlusion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty Of Dentistry, Cairo University
Cairo
Shorouk H Helmy, Master's, 00201015775110, shorouk.helmy@dentistry.cu.edu.eg
About this study
Official title: Clinical Evaluation of Silver Diamine Fluoride Combined With Potassium Iodide Versus Silver Diamine Fluoride in Management of Class I Carious Lesions Over a Period of 12 Months Follow-up: A Randomized Controlled Clinical Trial
To evaluate the clinical performance of High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) in deep class I carious lesions, over a period of one year follow-up. The null hypothesis tested in this study, that in deep class I carious lesions, the High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) will show the same clinical performance.
Read the detailed description
A sample of adults with an age range of 18-40 years old, having a permanent molar with deep class I carious lesions, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin), will be selected from the patients attending at the Conservative and Esthetic Dentistry Department Clinic, Faculty of Dentistry, Cairo University, and those who meet the study inclusion criteria will be recruited.
All selected 42 permanent molars will be randomly equally allocated into three groups according to the material used. Group I (n=14) Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) under High-Viscosity Glass Ionomer (EQUIA), Group II (n=14) Silver Diamine Fluoride (SDF) both under High-Viscosity Glass Ionomer (EQUIA), and Group III (n=14) High-Viscosity Glass Ionomer (EQUIA).
Steps in Short:
- Recruitment of the patients and full examination with diagnosis.
- Informed consent taking for the eligible participants to participate in the study.
- Randomization and allocation into three groups.
- Application of the intervention 1; Silver Diamine Fluoride combined with Potassium Iodide (Riva Star). Intervention 2; Silver Diamine Fluoride (SDF). Both under High-Viscosity Glass Ionomer (EQUIA). The comparator; High-Viscosity Glass Ionomer (EQUIA). All materials were manipulated according to the manufacturers' instructions.
- Baseline data collection of the clinical evaluation of the restorations using FDI criteria.
- Follow up at 3, 6, and 12 months for data collection of the clinical evaluation of the restorations using FDI criteria.
- Conditions
- Carious Lesion
- Being tested
- Silver Diamine Fluoride combined with Potassium Iodide., Silver Diamine Fluoride., High-Viscosity Glass Ionomer.
- 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 Fluoride combined with Potassium Iodide.Other
Also called Riva Star.
Riva Star, Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia.
Silver Diamine Fluoride.Other
Also called SDF.
A clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride.
High-Viscosity Glass Ionomer.Other
Also called EQUIA
A Glass Hybrid material.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | Silver Diamine Fluoride combined with Potassium Iodide (Riva Star), under High-Viscosity Glass Ionomer (EQUIA). Receives: Other: Silver Diamine Fluoride combined with Potassium Iodide. |
| Intervention 2 | Experimental | Silver Diamine Fluoride (SDF), under High-Viscosity Glass Ionomer (EQUIA). Receives: Other: Silver Diamine Fluoride. |
| The comparator | Active comparator | High-Viscosity Glass Ionomer (EQUIA). Receives: Other: High-Viscosity Glass Ionomer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological Properties: (Postoperative hyper-sensitivity)
will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by patient interviewing
Measured: 12 Months.
Secondary outcomes (2)
Functional Properties: (Radiographic examination and Patient's view) (Radiographic examination, and Patient's view)
will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by standardized periapical digital radiographs taken by parallel technique and by patient interviewing
Measured: 12 months.
Esthetic: Tooth Color
by Easy Shade. measuring unit: ΔE
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 posted3 Aug 2022
- Study start1 Feb 2022
- Primary completion10 Sep 2022 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carious LesionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 3-arm randomized clinical trial. Randomization will be done according to a check list including the number of participants divided into 3 groups of 14 patients (42 total) according to interventions/Control assessment methods.
- 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, Shorouk Hisham Helmy, Cairo University
- Investigators
- Shorouk H Helmy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485272
- Sponsor's protocol ID
- 14422019469442
- Status last verified
- Aug 2022
- First submitted
- 30 Jul 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after 1 year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Silver Diamine Fluoride Combined With Potassium Iodide Versus Silver Diamine Fluoride in Management of Class I Carious Lesions Over a Period of 12 Months Follow-up: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05485272
- Acronym / sponsor ID
- 14422019469442
- Conditions
- Carious Lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 10 Sep 2022 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 3 Aug 2022 (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 evaluate the clinical performance of High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) in deep class I carious lesions, over a period of one year follow-up. The null hypothesis tested in this study, that in deep class I carious lesions, the High-Viscosity Glass Ionomer (EQUIA) versus Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) and Sliver Diamine Fluoride (SDF) under High-Viscosity Glass Ionomer (EQUIA) will show the same clinical performance.
Detailed description
A sample of adults with an age range of 18-40 years old, having a permanent molar with deep class I carious lesions, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin), will be selected from the patients attending at the Conservative and Esthetic Dentistry Department Clinic, Faculty of Dentistry, Cairo University, and those who meet the study inclusion criteria will be recruited.
All selected 42 permanent molars will be randomly equally allocated into three groups according to the material used. Group I (n=14) Silver Diamine Fluoride combined with Potassium Iodide (Riva Star) under High-Viscosity Glass Ionomer (EQUIA), Group II (n=14) Silver Diamine Fluoride (SDF) both under High-Viscosity Glass Ionomer (EQUIA), and Group III (n=14) High-Viscosity Glass Ionomer (EQUIA).
Steps in Short:
- Recruitment of the patients and full examination with diagnosis.
- Informed consent taking for the eligible participants to participate in the study.
- Randomization and allocation into three groups.
- Application of the intervention 1; Silver Diamine Fluoride combined with Potassium Iodide (Riva Star). Intervention 2; Silver Diamine Fluoride (SDF). Both under High-Viscosity Glass Ionomer (EQUIA). The comparator; High-Viscosity Glass Ionomer (EQUIA). All materials were manipulated according to the manufacturers' instructions.
- Baseline data collection of the clinical evaluation of the restorations using FDI criteria.
- Follow up at 3, 6, and 12 months for data collection of the clinical evaluation of the restorations using FDI criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A 3-arm randomized clinical trial. Randomization will be done according to a check list including the number of participants divided into 3 groups of 14 patients (42 total) according to interventions/Control assessment methods.
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Other: Silver Diamine Fluoride combined with Potassium Iodide.Silver Diamine Fluoride combined with Potassium Iodide (Riva Star), under High-Viscosity Glass Ionomer (EQUIA). |
| Intervention 2 | Experimental | Other: Silver Diamine Fluoride.Silver Diamine Fluoride (SDF), under High-Viscosity Glass Ionomer (EQUIA). |
| The comparator | Active comparator | Other: High-Viscosity Glass Ionomer.High-Viscosity Glass Ionomer (EQUIA). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with deep class I carious lesions in molars, according to the international caries detection and assessment system (ICDAS), occlusal caries that scored 4 (underlying dark shadow from dentin), or 5 (Distinct cavity with visible dentin).
- Adults males or females.
- Age: 18-40 years old.
- Good Oral hygiene.
- Co-operative patients, approving to participate in the study.
Key exclusion criteria (6 listed)
- Patients having severe systemic diseases, allergies, or adverse medical histories.
- Patients complaining of sever or active periodontal disease.
- Lack of compliance.
- Teeth diagnosed with irreversible pulpitis.
- Non vital teeth.
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 Fluoride combined with Potassium Iodide.Also: Riva Star.Riva Star, Silver diamine fluoride 38% and potassium iodide, SDI, Bayswater, Australia. | Other | Intervention 1 |
| Silver Diamine Fluoride.Also: SDF.A clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride. | Other | Intervention 2 |
| High-Viscosity Glass Ionomer.Also: EQUIAA Glass Hybrid material. | Other | The comparator |
Primary outcome
Biological Properties: (Postoperative hyper-sensitivity)
Time frame: 12 Months.
will be ranked according to Federation Dentaire Internationale criteria (FDI). Scoring system (1,2,3,4,5) by patient interviewing
2 secondary outcomes
Functional Properties: (Radiographic examination and Patient's view) (Radiographic examination, and Patient's view)
Time frame: 12 months.
Esthetic: Tooth Color
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 3 Aug 2022.
- Individual participant dataSharing planned: No. after 1 year.
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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.
Shorouk H Helmy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride combined with Potassium Iodide., Silver Diamine Fluoride. and High-Viscosity Glass Ionomer. in people with Carious Lesion, 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 7 inclusion and 6 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 3 Aug 2022. 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.
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 Shorouk H Helmy, Master's (00201015775110, shorouk.helmy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological Properties: (Postoperative hyper-sensitivity) (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 3 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.