Dental CariesPhase 3NCT05188846
Caries Arresting in Primary Molar Teeth Using SDF VS ART
A Phase 3 study testing SDF and SDF + ART (SMART technique ) in people with Dental Caries, run by Ola Adel Abdelfadil Ahmed.
Trial summary
This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS). Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- SDF and SDF + ART (SMART technique )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2022to Mar 2023
- Phase
- Phase 3
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Both genders.
- Decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) .
Who cannot join
- History of systemic conditions.
- Allergy to silver.
- Oral ulceration.
- Teeth with proximal or multi-surfaces caries, pulp pathology.
Trial locations and contacts
No sites are listed yet.
Passant Nagi, PHD contact
About this study
Official title: Caries Arresting Treatment Using Silver Diamine Fluoride (SDF) Versus SDF Modified Atraumatic Restorative Technique (SMART) for Management of Carious Vital Primary Teeth: A Randomized Clinical Trial
This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS).
Read the detailed description
Early childhood caries (ECC) is a type of dental caries in the teeth of infants and children that is represented as one of the most prevalent dental problems in this period, which can lead to pain, infection, interference with eating.
According to the ADA, (ECC) is described as "the presence of one or more decayed ( cavitated or non cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth" in children.
Overall, 50% of children have one or more decayed primary teeth by the end of toddler age, but the importance of these teeth should not be neglected, because, healthy teeth in childhood have an important role in the eruption of healthy permanent teeth, healthy nutrition, and aesthetic appearance.
Conventional treatment methods (drill and fill) involve the use of rotary burs under local anesthesia which develops pain and needs cooperative child and highly trained dental health personnel and consider an invasive technique, on the other hand (ART) is an approach to increase accessibility to restorative treatment, inexpensive and can be employed in regions without electricity and running water. In addition, ART is a minimally invasive treatment that requires no rotary instruments or local anesthesia to remove decayed tissue before sealing the cavity with high viscosity glass ionomer cement (GIC).
(SDF), a low-cost cariostatic agent and a noninvasive method for caries management, treatment with SDF are easy, effective, and well accepted, it is also an alternative to traditional restorative treatment and may influence the reduction of untreated carious lesions in childhood
- Conditions
- Dental Caries
- Being tested
- SDF, SDF + ART (SMART technique )
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFOther
- Group 1: cleaning the occlusal surface to be treated with toothbrush. Decayed tissue from the affected teeth will not be removed for the SDF group.
Clinical procedure for SDF application: it will apply according to the SDF manufacturer Instructions as follows:(1) the surrounding gingival tissues and lips will be protected with petroleum jelly to avoid staining and irritation,(2) the affected tooth will be isolated and keep dry with cotton rolls and saliva ejectors, (3) one drop of SDF (SDI RIVA STAR ), will be placed into a disposable dish, (4) SDF will be applied with a micro-sponge directly to the affected tooth surface(s), (5) allowed to soak in for 2 min, then air-dried. Then will be followed by the Potassium iodide (KI) liquid to decrease discoloration caused by SDF. The KI liquid will be reapplied until no more white perception observed to form.
SDF + ART (SMART technique )Other
- Group 2: SDF+ART clinical procedure: (1)cleaning the occlusal surface to be treated with toothbrush.,(2) carious dentin will be removed using a small excavator (Spoon excavator ),(3) the cavity will be cleaned and dried, (4)cavity walls and floor will be conditioned for 10s, then washed and dried, (5) SDF will be applied as mentioned above followed by cavity restoration using resin-reinforced glass ionomer restorative material (SDI RIVA ).
| Study group | Role | What they receive |
|---|---|---|
| SDF | Experimental | Not described Receives: Other: SDF |
| SDF + ART ( SMART technique ) | Active comparator | Not described Receives: Other: SDF + ART (SMART technique ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECOHIS
Early Childhood Oral Health Impact Scale.
Measured: 6 month
Secondary outcomes (1)
- Clinical effectiveness Caries arrestment/ treatment
International Caries Detection and Assessment System (ICDAS II)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start25 Jan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionMar 2023 (estimated)
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ola Adel Abdelfadil Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ola Adel Abdelfadil Ahmed, Cairo University
- Investigators
- Nevine Waly, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188846
- Sponsor's protocol ID
- SDF VS ART
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caries Arresting Treatment Using Silver Diamine Fluoride (SDF) Versus SDF Modified Atraumatic Restorative Technique (SMART) for Management of Carious Vital Primary Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05188846
- Acronym / sponsor ID
- SDF VS ART
- Conditions
- Dental Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ola Adel Abdelfadil AhmedUniversity, hospital or other
- Study start
- 25 Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 12 Jan 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.
This study aimed to evaluate the oral health related quality of life ( OHRQoL), during caries management in children with vital carious primary teeth with no signs of irreversible pulpitis using SDF alone or SDF in combination with ART, using Early Childhood Oral Health Impact Scale (ECOHIS).
Detailed description
Early childhood caries (ECC) is a type of dental caries in the teeth of infants and children that is represented as one of the most prevalent dental problems in this period, which can lead to pain, infection, interference with eating.
According to the ADA, (ECC) is described as "the presence of one or more decayed ( cavitated or non cavitated lesions), missing (due to caries), or filled tooth surfaces in any primary tooth" in children.
Overall, 50% of children have one or more decayed primary teeth by the end of toddler age, but the importance of these teeth should not be neglected, because, healthy teeth in childhood have an important role in the eruption of healthy permanent teeth, healthy nutrition, and aesthetic appearance.
Conventional treatment methods (drill and fill) involve the use of rotary burs under local anesthesia which develops pain and needs cooperative child and highly trained dental health personnel and consider an invasive technique, on the other hand (ART) is an approach to increase accessibility to restorative treatment, inexpensive and can be employed in regions without electricity and running water. In addition, ART is a minimally invasive treatment that requires no rotary instruments or local anesthesia to remove decayed tissue before sealing the cavity with high viscosity glass ionomer cement (GIC).
(SDF), a low-cost cariostatic agent and a noninvasive method for caries management, treatment with SDF are easy, effective, and well accepted, it is also an alternative to traditional restorative treatment and may influence the reduction of untreated carious lesions in childhood
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDF | Experimental | Other: SDF |
| SDF + ART ( SMART technique ) | Active comparator | Other: SDF + ART (SMART technique ) |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Both genders.
- Decayed vital primary molars (asymptomatic teeth with active single-surface lesions, vital pulp no signs of irreversible pulpitis) .
Key exclusion criteria (4 listed)
- History of systemic conditions.
- Allergy to silver.
- Oral ulceration.
- Teeth with proximal or multi-surfaces caries, pulp pathology.
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 |
|---|---|---|
| SDF1. Group 1: cleaning the occlusal surface to be treated with toothbrush. Decayed tissue from the affected teeth will not be removed for the SDF group. Clinical procedure for SDF application: it will apply according to the SDF manufacturer Instructions as follows:(1) the surrounding gingival tissues and lips will be protected with petroleum jelly to avoid staining and irritation,(2) the affected tooth will be isolated and keep dry with cotton rolls and saliva ejectors, (3) one drop of SDF (SDI RIVA STAR ), will be placed into a disposable dish, (4) SDF will be applied with a micro-sponge directly to the affected tooth surface(s), (5) allowed to soak in for 2 min, then air-dried. Then will be followed by the Potassium iodide (KI) liquid to decrease discoloration caused by SDF. The KI liquid will be reapplied until no more white perception observed to form. | Other | SDF |
| SDF + ART (SMART technique )2. Group 2: SDF+ART clinical procedure: (1)cleaning the occlusal surface to be treated with toothbrush.,(2) carious dentin will be removed using a small excavator (Spoon excavator ),(3) the cavity will be cleaned and dried, (4)cavity walls and floor will be conditioned for 10s, then washed and dried, (5) SDF will be applied as mentioned above followed by cavity restoration using resin-reinforced glass ionomer restorative material (SDI RIVA ). | Other | SDF + ART ( SMART technique ) |
Primary outcome
ECOHIS
Time frame: 6 month
Early Childhood Oral Health Impact Scale.
1 secondary outcome
- Clinical effectiveness Caries arrestment/ treatment
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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.
Passant Nagi, PHD contact
Nevine Waly, Professor study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SDF and SDF + ART (SMART technique ) in people with Dental Caries, run by Ola Adel Abdelfadil Ahmed.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ola Adel, Master (01012006422, olaadel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECOHIS (time frame: 6 month). 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 12 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.