Dental CariesPhase 4NCT07023939
Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars
A Phase 4 study testing ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment in people with Dental Caries and Dental Caries in Children, run by Beirut Arab University at 1 site in Lebanon.
Trial summary
The goal of this clinical trial is to evaluate and compare the short-term effectiveness of two minimally invasive treatments-Atraumatic Restorative Treatment (ART) and Silver-Modified Atraumatic Restorative Treatment (SMART)-in managing dentine caries lesions in the primary molars of children aged 3 to 7 years with… Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Dental Caries, Dental Caries in Children
- What is being tested?
- ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteLebanon
- Study dates
- 2 May 2023to 10 Dec 2024
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Study Participants: Generally healthy children aged 3 to 7 years
- Behavior Rating (Frankel's Scale):
- Negative (Score 2) Positive (Score 3)
- Dental Condition: At least two bilateral asymptomatic decayed primary molars
- Caries Classification: based on International caries detection and assessment systemII I(CDAS II) Scores 4 \& 5 (Occlusal or occluso-proximal carious dentin lesions)
Who cannot join
- Children with systemic diseases/conditions (ASA Type I)
- Behavior Rating (Frankel's Scale) Definitely positive(Score 1) Definitely negative (Score 4).
- Teeth showing irreversible pulpitis or pulpal pathology (abscess, fistula, mobility)
- Teeth with very deep cavities or score 6 based on ICDAS II
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study on the Clinical Outcomes of Restoring Dentine Caries Lesions in Primary Molars Using Silver Modified Versus Conventional Atraumatic Restorative Treatment (A Randomized Clinical Trial)
The goal of this clinical trial is to evaluate and compare the short-term effectiveness of two minimally invasive treatments-Atraumatic Restorative Treatment (ART) and Silver-Modified Atraumatic Restorative Treatment (SMART)-in managing dentine caries lesions in the primary molars of children aged 3 to 7 years with Early Childhood Caries (ECC). The main questions it aims to answer are:
- Which treatment method (ART or SMART) results in higher clinical success after six months?
- How do ART and SMART treatments affect the Oral Health-Related Quality of Life (OHRQoL) of the children? The researcher will compare teeth restored using ART with those treated using SMART (which includes the application of silver diamine fluoride before restoration) to see if one approach leads to better restoration outcomes and to assess how these restorations will impact the quality of life.
Read more
Participants will:
- Receive both types of treatments in different teeth (split-mouth design).
- Undergo clinical evaluation of the treated teeth at baseline and six months to assess success based on restoration retention, integrity, and absence of secondary caries.
- Have their parents complete a quality-of-life questionnaire (A-ECOHIS) at the start and at the six-month follow-up.
Read the detailed description
Aim of the Study in details:
Primary Aim
This study aims to evaluate and compare the clinical outcomes of Silver-Modified Atraumatic Restorative Treatment (SMART) and conventional Atraumatic Restorative Treatment (ART) in the management of carious primary molars in preschool children. This comparison includes:
- Success rate: which include restoration integrity, marginal adaptation, absence of secondary caries, and tooth vitality.
- Retention rate: Determined by monitoring whether the restoration remains fully or partially retained over time
- Caries arrest: where arrested lesions present with hard, darkened surfaces and no progression in lesion size Secondary Aim
- To describe the change in oral health-related quality of life of preschool children before and after placement of ART and SMART restorations Randomization The sample size was specified by using the G* power test, assuming a statistical level of significance of 95% and power of 80% with normal distribution, and effect size calculated from means and standard deviation of 2 groups obtained from a previous similar study (Jiang et al.,2021). The original sample size was 64 molars and was increased up to 80 to avoid any drop out.
Eligible molars were randomly and equally assigned to either the SMART or ART group using a randomization software (Random.org).
Calibration:
One calibrated examiner was responsible for all the dental examinations. The intra-examiner agreement was assessed by re-examining 10% of the sample. The Kappa statistic for intra-examiner reliability was 0.87 which indicates consistency in the application of scoring criteria over the study period.
Blinding and Outcome Assessment Follow up assessments were done by the operator at 6 months. Complete blinding was not feasible in some cases particularly where GIC restorations where lost due to noticeable staining of the cavity with SDF. However, blinding of the data analyst was done where all study data was labelled with non-identifying Alphabet letters to reduce risk of bias.
Data Collection:
At baseline, parents completed a two-part questionnaire: Part 1 gathered general demographic information, while Part 2 included the validated Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS) validated by Farsi et al in 2017[20]. At the second follow-up visit. parents completed the same questionnaire again.
Statistical Analysis Data were statistically analyzed through SPSS 28 (SPSS IBM statistics, USA). Based on the results of the Shapiro-Wilk test, most of the data were determined to follow a normal distribution. The significance level was set at p ≤ 0.05. Fishers exact test was used to compare the outcomes between ART and SMART at a single time point. Categorical data like the relation between the success rate of both treatments and the type of the cavity was analyzed by using the Chi-Square Test of Independence. Paired Samples t-Test was used to assess the changes in ECOHIS scores at baseline and after intervention.
- Conditions
- Dental Caries, Dental Caries in Children
- Being tested
- ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment
- Keywords
- Early Childhood caries, SilverDiamine flouride, Glass Ionomer Cement, Minimal Intervention Dentistry
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative TreatmentDrug
ART Group:
Selective caries removal was done using hand instruments-carious dentin was excavated from the axial walls with a spoon excavator, and unsupported enamel was carefully removed using a hatchet. On the pulpal floor, only soft, completely demineralized dentin was removed until firm dentin was reached.
SMART Group:
the surrounding gingival tissues and lips were protected with petroleum jelly to avoid staining and irritation (2) ) one drop of SDF (Advantage Arrest ™, Elevate Oral Care, USA) was placed into a disposable dish, (4) SDF was applied with a bended micro-sponge directly to the affected tooth surfaces for minimum of 60 seconds, (3) excess was blotted with a cotton pellet, (4)and the area was air-dried while maintaining isolation for up to three minutes.
| Study group | Role | What they receive |
|---|---|---|
| ART- Atraumatic Restorative Treatment | Active comparator | Children received Atraumatic Restorative Treatment (ART), which involved selective caries removal using hand instruments and restoration with high-viscosity glass ionomer cement. Carious dentin was excavated from the axial walls with a spoon excavator, unsupported enamel was removed with a hatchet, and only soft demineralized dentin on the pulpal floor was removed until firm dentin was reached. Receives: Drug: ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment |
| SMART_Silver-Modified Atraumatic Restorative Treatment | Experimental | Children received Silver-Modified Atraumatic Restorative Treatment (SMART), which included the application of 38% silver diamine fluoride (SDF) followed by ART. Gingival tissues and lips were protected with petroleum jelly. One drop of SDF (Advantage Arrest™, Elevate Oral Care, USA) was placed into a disposable dish and applied to affected tooth surfaces using a bent micro-sponge for at least 60 seconds. Excess was blotted with a cotton pellet, and the area was air-dried under isolation for up to three minutes. ART was then completed using high-viscosity glass ionomer cement. Receives: Drug: ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome : Success rate of restorations assessed by Modified ART Criteria
The proportion of restorations that meet criteria for success based on Modified ART CRITERIA evaluation UNIT OF MEASURE: % OF restorations rated successful
Measured: 6 months post-treatment
Secondary outcomes (1)
Change in Oral Health-Related Quality of Life (OHRQoL) assessed by Early Childhood Oral Health Impact Scale (ECOHIS) filled by parents
Mean change in total ECOHIS score from baseline to 6 months post-treatment. The ECOHIS includes 13 items scored on a 5-point Likert scale (0 = never to 4 = very often). Total score range: 0-52. Higher scores indicate worse oral health-related quality of life.
Unit of Measure: Mean score change on ECOHIS
Measured: Baseline and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start2 May 2023
- Primary completion16 Jan 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- split mouth design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Solh, Beirut Arab University
- Investigators
- Dr.Ahmad Tarabaih, Assoc.Prof, Study director, Department of Pediatric Dentistry, Beirut Arab universityDr.Ahmad Holiel, Assis.Prof, Study director, Department of Esthetic and Restorative Dentistry, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023939
- Sponsor's protocol ID
- 2022-H-011-D-M-0489
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Solh SK, Holiel AA, Tarabaih AS. Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars: A Randomized Clinical Trial on Minimally Invasive Caries Management and Oral Health-Related Quality of Life. Clin Exp Dent Res. 2026 Feb;12(1):e70299. doi: 10.1002/cre2.70299.
PubMed 41632901
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on the Clinical Outcomes of Restoring Dentine Caries Lesions in Primary Molars Using Silver Modified Versus Conventional Atraumatic Restorative Treatment (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07023939
- Acronym / sponsor ID
- 2022-H-011-D-M-0489
- Conditions
- Dental Caries, Dental Caries in Children
- Keywords
- Early Childhood caries, SilverDiamine flouride, Glass Ionomer Cement, Minimal Intervention Dentistry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 17 Jun 2025 (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 goal of this clinical trial is to evaluate and compare the short-term effectiveness of two minimally invasive treatments-Atraumatic Restorative Treatment (ART) and Silver-Modified Atraumatic Restorative Treatment (SMART)-in managing dentine caries lesions in the primary molars of children aged 3 to 7 years with Early Childhood Caries (ECC). The main questions it aims to answer are:
- Which treatment method (ART or SMART) results in higher clinical success after six months?
- How do ART and SMART treatments affect the Oral Health-Related Quality of Life (OHRQoL) of the children? The researcher will compare teeth restored using ART with those treated using SMART (which includes the application of silver diamine fluoride before restoration) to see if one approach leads to better restoration outcomes and to assess how these restorations will impact the quality of life.
Participants will:
- Receive both types of treatments in different teeth (split-mouth design).
- Undergo clinical evaluation of the treated teeth at baseline and six months to assess success based on restoration retention, integrity, and absence of secondary caries.
- Have their parents complete a quality-of-life questionnaire (A-ECOHIS) at the start and at the six-month follow-up.
Detailed description
Aim of the Study in details:
Primary Aim
This study aims to evaluate and compare the clinical outcomes of Silver-Modified Atraumatic Restorative Treatment (SMART) and conventional Atraumatic Restorative Treatment (ART) in the management of carious primary molars in preschool children. This comparison includes:
- Success rate: which include restoration integrity, marginal adaptation, absence of secondary caries, and tooth vitality.
- Retention rate: Determined by monitoring whether the restoration remains fully or partially retained over time
- Caries arrest: where arrested lesions present with hard, darkened surfaces and no progression in lesion size Secondary Aim
- To describe the change in oral health-related quality of life of preschool children before and after placement of ART and SMART restorations Randomization The sample size was specified by using the G* power test, assuming a statistical level of significance of 95% and power of 80% with normal distribution, and effect size calculated from means and standard deviation of 2 groups obtained from a previous similar study (Jiang et al.,2021). The original sample size was 64 molars and was increased up to 80 to avoid any drop out.
Eligible molars were randomly and equally assigned to either the SMART or ART group using a randomization software (Random.org).
Calibration:
One calibrated examiner was responsible for all the dental examinations. The intra-examiner agreement was assessed by re-examining 10% of the sample. The Kappa statistic for intra-examiner reliability was 0.87 which indicates consistency in the application of scoring criteria over the study period.
Blinding and Outcome Assessment Follow up assessments were done by the operator at 6 months. Complete blinding was not feasible in some cases particularly where GIC restorations where lost due to noticeable staining of the cavity with SDF. However, blinding of the data analyst was done where all study data was labelled with non-identifying Alphabet letters to reduce risk of bias.
Data Collection:
At baseline, parents completed a two-part questionnaire: Part 1 gathered general demographic information, while Part 2 included the validated Arabic version of the Early Childhood Oral Health Impact Scale (A-ECOHIS) validated by Farsi et al in 2017[20]. At the second follow-up visit. parents completed the same questionnaire again.
Statistical Analysis Data were statistically analyzed through SPSS 28 (SPSS IBM statistics, USA). Based on the results of the Shapiro-Wilk test, most of the data were determined to follow a normal distribution. The significance level was set at p ≤ 0.05. Fishers exact test was used to compare the outcomes between ART and SMART at a single time point. Categorical data like the relation between the success rate of both treatments and the type of the cavity was analyzed by using the Chi-Square Test of Independence. Paired Samples t-Test was used to assess the changes in ECOHIS scores at baseline and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- split mouth design
| Arm | Type | Receives |
|---|---|---|
| ART- Atraumatic Restorative Treatment | Active comparator | Drug: ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative TreatmentChildren received Atraumatic Restorative Treatment (ART), which involved selective caries removal using hand instruments and restoration with high-viscosity glass ionomer cement. Carious dentin was excavated from the axial walls with a spoon excavator, unsupported enamel was removed with a hatchet, and only soft demineralized dentin on the pulpal floor was removed until firm dentin was reached. |
| SMART_Silver-Modified Atraumatic Restorative Treatment | Experimental | Drug: ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative TreatmentChildren received Silver-Modified Atraumatic Restorative Treatment (SMART), which included the application of 38% silver diamine fluoride (SDF) followed by ART. Gingival tissues and lips were protected with petroleum jelly. One drop of SDF (Advantage Arrest™, Elevate Oral Care, USA) was placed into a disposable dish and applied to affected tooth surfaces using a bent micro-sponge for at least 60 seconds. Excess was blotted with a cotton pellet, and the area was air-dried under isolation for up to three minutes. ART was then completed using high-viscosity glass ionomer cement. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Study Participants: Generally healthy children aged 3 to 7 years
- Behavior Rating (Frankel's Scale):
- Negative (Score 2) Positive (Score 3)
- Dental Condition: At least two bilateral asymptomatic decayed primary molars
- Caries Classification: based on International caries detection and assessment systemII I(CDAS II) Scores 4 \& 5 (Occlusal or occluso-proximal carious dentin lesions)
Key exclusion criteria (4 listed)
- Children with systemic diseases/conditions (ASA Type I)
- Behavior Rating (Frankel's Scale) Definitely positive(Score 1) Definitely negative (Score 4).
- Teeth showing irreversible pulpitis or pulpal pathology (abscess, fistula, mobility)
- Teeth with very deep cavities or score 6 based on ICDAS II
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 |
|---|---|---|
| ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative TreatmentART Group: Selective caries removal was done using hand instruments-carious dentin was excavated from the axial walls with a spoon excavator, and unsupported enamel was carefully removed using a hatchet. On the pulpal floor, only soft, completely demineralized dentin was removed until firm dentin was reached. SMART Group: the surrounding gingival tissues and lips were protected with petroleum jelly to avoid staining and irritation (2) ) one drop of SDF (Advantage Arrest ™, Elevate Oral Care, USA) was placed into a disposable dish, (4) SDF was applied with a bended micro-sponge directly to the affected tooth surfaces for minimum of 60 seconds, (3) excess was blotted with a cotton pellet, (4)and the area was air-dried while maintaining isolation for up to three minutes. | Drug | ART- Atraumatic Restorative Treatment, SMART_Silver-Modified Atraumatic Restorative Treatment |
Primary outcome
primary outcome : Success rate of restorations assessed by Modified ART Criteria
Time frame: 6 months post-treatment
The proportion of restorations that meet criteria for success based on Modified ART CRITERIA evaluation UNIT OF MEASURE: % OF restorations rated successful
1 secondary outcome
Change in Oral Health-Related Quality of Life (OHRQoL) assessed by Early Childhood Oral Health Impact Scale (ECOHIS) filled by parents
Time frame: Baseline and 6-month follow-up
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 17 Jun 2025.
- Derived from this study: PubMed 41632901Solh SK, Holiel AA, Tarabaih AS. Atraumatic Versus Silver-Modified Atraumatic Restorative Treatment in Primary Molars: A Randomized Clinical Trial on Minimally Invasive Caries Management and Oral Health-Related Quality of Life. Clin Exp Dent Res. 2026 Feb;12(1):e70299. doi: 10.1002/cre2.70299.
- 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.
Dr.Ahmad Tarabaih, Assoc.Prof study director
Department of Pediatric Dentistry, Beirut Arab university
Dr.Ahmad Holiel, Assis.Prof study director
Department of Esthetic and Restorative Dentistry, Beirut Arab University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ART: Atraumatic restorative treatment, SMART: Silver-Modified Atraumatic Restorative Treatment in people with Dental Caries and Dental Caries in Children, run by Beirut Arab University at 1 site in Lebanon.
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 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 17 Jun 2025. 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 Lebanon. 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?
primary outcome : Success rate of restorations assessed by Modified ART Criteria (time frame: 6 months post-treatment). 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 NCT07023939, which also lists 1 linked publication.
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 17 Jun 2025.