Occlusal CariesPhase 2/3NCT04354636
Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment
A Phase 2/3 study testing Silver modified atraumatic restorative treatment and Atraumatic restorative treatment in people with Occlusal Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Occlusal Caries
- What is being tested?
- Silver modified atraumatic restorative treatment and Atraumatic restorative treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 11 Oct 2023
- Phase
- Phase 2/3
- 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
- • Patient and parent cooperation and compliance.
- Children aged 4 - 6 years
- Second primary molars with occlusal caries.
- No clinical signs and symptoms of pulp involvement
- No radiographic abnormalities
Who cannot join
- • Uncooperative children or parents
- Children with systemic diseases
- Children with previous allergies to any of the used materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Radiographic Evaluation After the Use of Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment in the Management of Occlusal Caries of Primary Molars in Preschool Children: Randomized Clinical Trial
Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically
Read the detailed description
Aim of the study:
To evaluate the clinical and radiographic outcomes after the use of silver modified atraumatic restorative treatment versus atraumatic restorative treatment in the management of occlusal caries in primary molars in preschool children.
PICO:
Population:
Preschool children (4-6 years) with occlusal caries in second primary molars.
Intervention:
Silver modified atraumatic restorative treatment
Comparator/Control:
Atraumatic restorative treatment.
Outcomes:
Pain (provoked or spontaneous) OHRQoL(oral health related to quality of life) Parental esthetic perception Failure of restoration Caries density in radiograph
Time:
3, 6 and 12 months
Study design:
A randomized clinical trial
- Conditions
- Occlusal Caries
- Being tested
- Silver modified atraumatic restorative treatment, Atraumatic restorative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver modified atraumatic restorative treatmentDrug
Silver diamine fluoride that will be applied during atraumatic restorative treatment
Atraumatic restorative treatmentOther
Using atraumatic restorative treatment without applying silver diamine fluoride
| Study group | Role | What they receive |
|---|---|---|
| Silver modified atraumatic restorative treatment | Experimental | Using silver diamine fluoride incorporated with atraumatic restorative treatment Receives: Drug: Silver modified atraumatic restorative treatment |
| Atraumatic restorative treatment | Active comparator | Using atraumatic restorative treatment without the application of silver diamine fluoride Receives: Other: Atraumatic restorative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)
Pain reported-Pain history that occurs after treatment at any point (will be recorded at the follow up intervals) Outcome will be binary (yes/no)
Measured: 12 months
Secondary outcomes (4)
OHRQoL(oral health related to quality of life)
The Early Childhood Oral Health Impact Scale (A-ECOHIS) Score 0-52. There will be 13 questions each question with a score 0-5 where 0 = excellent, 1=very good, 2=good, 3=fair , 4=poor and 5= unknown so the less the score the better is the oral health related to quality of life.
Measured: 3 months
Questioning parents about their aesthetic perception
Parent reported (parent is asked whether he/she is accepting the tooth appearance or not) Outcome will be binary (yes/no)
Measured: 3 months
ART assessment criteria (Codes 00-90)
Failure of restoration according to the code in the ART assessment criteria (Codes 00-90).
Code 00 or 10 are considered successful, codes 11-40 are classified as failures, and codes 50-90 are assigned in case the tooth was unavailable for evaluation
Measured: 12 months
Caries density in radiograph
Pixel grey value
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 posted21 Apr 2020
- Study start1 Sep 2021
- Primary completion3 Oct 2022
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Occlusal 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatallah Sameh Ahmed Farouk Abdelhamid, Cairo University
- Investigators
- Sherif B El Tawil, Professor, Study director, Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo universityDalia M Moheb, Associate professor, Study director, Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354636
- Sponsor's protocol ID
- SMART_ART
- Status last verified
- Dec 2024
- First submitted
- 13 Apr 2020
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4.
PubMed 31279925Saber AM, El-Housseiny AA, Alamoudi NM. Atraumatic Restorative Treatment and Interim Therapeutic Restoration: A Review of the Literature. Dent J (Basel). 2019 Mar 7;7(1):28. doi: 10.3390/dj7010028.
PubMed 30866534Oliveira BH, Rajendra A, Veitz-Keenan A, Niederman R. The Effect of Silver Diamine Fluoride in Preventing Caries in the Primary Dentition: A Systematic Review and Meta-Analysis. Caries Res. 2019;53(1):24-32. doi: 10.1159/000488686. Epub 2018 Jun 6.
PubMed 29874642van Gemert-Schriks MC, van Amerongen WE, ten Cate JM, Aartman IH. Three-year survival of single- and two-surface ART restorations in a high-caries child population. Clin Oral Investig. 2007 Dec;11(4):337-43. doi: 10.1007/s00784-007-0138-8. Epub 2007 Aug 21.
PubMed 17710452
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation After the Use of Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment in the Management of Occlusal Caries of Primary Molars in Preschool Children: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04354636
- Acronym / sponsor ID
- SMART_ART
- Conditions
- Occlusal Caries
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 21 Apr 2020 (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.
Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically
Detailed description
Aim of the study:
To evaluate the clinical and radiographic outcomes after the use of silver modified atraumatic restorative treatment versus atraumatic restorative treatment in the management of occlusal caries in primary molars in preschool children.
PICO:
Population:
Preschool children (4-6 years) with occlusal caries in second primary molars.
Intervention:
Silver modified atraumatic restorative treatment
Comparator/Control:
Atraumatic restorative treatment.
Outcomes:
Pain (provoked or spontaneous) OHRQoL(oral health related to quality of life) Parental esthetic perception Failure of restoration Caries density in radiograph
Time:
3, 6 and 12 months
Study design:
A randomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver modified atraumatic restorative treatment | Experimental | Drug: Silver modified atraumatic restorative treatmentUsing silver diamine fluoride incorporated with atraumatic restorative treatment |
| Atraumatic restorative treatment | Active comparator | Other: Atraumatic restorative treatmentUsing atraumatic restorative treatment without the application of silver diamine fluoride |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Patient and parent cooperation and compliance.
Key exclusion criteria (3 listed)
- • Uncooperative children or parents
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 modified atraumatic restorative treatmentSilver diamine fluoride that will be applied during atraumatic restorative treatment | Drug | Silver modified atraumatic restorative treatment |
| Atraumatic restorative treatmentUsing atraumatic restorative treatment without applying silver diamine fluoride | Other | Atraumatic restorative treatment |
Primary outcome
Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)
Time frame: 12 months
Pain reported-Pain history that occurs after treatment at any point (will be recorded at the follow up intervals) Outcome will be binary (yes/no)
4 secondary outcomes
OHRQoL(oral health related to quality of life)
Time frame: 3 months
Questioning parents about their aesthetic perception
Time frame: 3 months
ART assessment criteria (Codes 00-90)
Time frame: 12 months
Caries density in radiograph
Time frame: 12 months
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 30 Dec 2024.
- Background: PubMed 31279925Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4.
- Background: PubMed 30866534Saber AM, El-Housseiny AA, Alamoudi NM. Atraumatic Restorative Treatment and Interim Therapeutic Restoration: A Review of the Literature. Dent J (Basel). 2019 Mar 7;7(1):28. doi: 10.3390/dj7010028.
- Background: PubMed 29874642Oliveira BH, Rajendra A, Veitz-Keenan A, Niederman R. The Effect of Silver Diamine Fluoride in Preventing Caries in the Primary Dentition: A Systematic Review and Meta-Analysis. Caries Res. 2019;53(1):24-32. doi: 10.1159/000488686. Epub 2018 Jun 6.
- Background: PubMed 17710452van Gemert-Schriks MC, van Amerongen WE, ten Cate JM, Aartman IH. Three-year survival of single- and two-surface ART restorations in a high-caries child population. Clin Oral Investig. 2007 Dec;11(4):337-43. doi: 10.1007/s00784-007-0138-8. Epub 2007 Aug 21.
- 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.
Sherif B El Tawil, Professor study director
Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
Dalia M Moheb, Associate professor study director
Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Silver modified atraumatic restorative treatment and Atraumatic restorative treatment in people with Occlusal Caries, 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 5 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 30 Dec 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous) (time frame: 12 months). 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 NCT04354636, which also lists 4 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 30 Dec 2024.