Dental CariesPhase 4NCT03881020
Comparison of Silver Modified and Conventional Atraumatic Restorative Treatment Modalities
A Phase 4 study testing Silver diamine Fluoride 38% and Conventional atraumatic restorative treatment in people with Dental Caries, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study is a randomized controlled trial aiming to compare the effectiveness of Silver modified atraumatic restorative technique and (SMART) and conventional atraumatic restorative technique (ART) regarding their caries arresting properties in primary molars, patient acceptance and cost effectiveness. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Silver diamine Fluoride 38% and Conventional atraumatic restorative treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Aug 2020to 30 Dec 2021
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically free children.
- Clinical examination revealing at least one second primary molar with single surface active dentine carious lesions.
- Children who agreed to participate and whose parents signed an informed consent.
- Cooperative or potentially cooperative children according to Wright Classification
Who cannot join
- Children who have known allergies to silver products.
- Children with special health care needs or any medical conditions.
- Children with designated molars having more than one third of their crown missing.
- Children with designated molars showing signs of pulpal pathology such as spontaneous pain, presence of an abscess or sinus or mobility.
- Children with designated molars having an existing restoration.
- Children with designated molars having deep carious lesions with close proximity to the pulp.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Silver Modified and Conventional Atraumatic Restorative Treatment Modalities in Primary Molars in a Group of Egyptian School Children. A Randomized Controlled Trial
The study is a randomized controlled trial aiming to compare the effectiveness of Silver modified atraumatic restorative technique and (SMART) and conventional atraumatic restorative technique (ART) regarding their caries arresting properties in primary molars, patient acceptance and cost effectiveness.
Read the detailed description
5-9 years old school children will be recruited for the study. Parents of eligible children will be informed in full details about the purpose of the study and any possible side effects. Prior to enrollment of children in the study, parents will have to sign a written informed consent outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University. Children will be also informed about the nature of the study using age appropriate language and will have to give an assent to participate before being enrolled in the study.
Children will be clinically examined with the help of a plane dental mirror and an explorer. A single calibrated investigator will undertake all clinical examinations and deliver dental treatment to all patients to ensure standardization. After clinical examination, all children included in the study will be randomly allocated to be one of the two groups either control group (Conventional ART) or experimental group (SMART). Randomization sequence will be electronically generated using (http://randomization.com/). To ensure concealment of allocation, the randomly generated sequence will be concealed and enclosed in sealed, opaque envelopes. The envelopes will be randomly picked up by the children for group allocation. Follow up examinations will be done by a calibrated examiner who was not involved in the treatment procedures. Patients who are no longer willing to continue in the study will have the right to quit at any time without any penalty. All patient information will be collected and recorded in the patient examination chart. All information will be kept as a hard copy and as an electronic copy as well. Patient information will be confidential information that should never be exposed at any point. The data concerning the subjects will be entered into the database with a numerical code only for the purpose of confidentiality.
All data will be tabulated, summarized and statistically analyzed. Data will be statistically described in terms of mean, standard deviation, median and range, or frequencies (number of cases) and percentages when appropriate.
Comparison of numerical variables between the study groups will be done using Student t test for independent samples in comparing normally distributed data and Mann Whitney U test for independent samples when data is not normally distributed. For comparing categorical data, Chi-square test will be performed. Exact test will be used instead when the expected frequency is less than 5.Correlation between various variables will be done using Pearson moment correlation equation for linear relation in normally distributed variables and Spearman rank correlation equation for non-normal variables.
A probability value (p value) less than 0.05 is considered statistically significant. All statistical calculations will be done using computer programs Microsoft Excel 2007 (Microsoft Corporation, NY, USA) and IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows.
- Conditions
- Dental Caries
- Being tested
- Silver diamine Fluoride 38%, Conventional atraumatic restorative treatment
- 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 38%Drug
Also called Advantage Arrest Silver diamine Fluoride 38%
In the intervention group 38% Silver Diamine Fluoride will be applied to the surface of the isolated lesion for a period of 1 minute followed by glass ionomer restoration at the same visit.
Conventional atraumatic restorative treatmentProcedure or surgery
Also called ART
In the active comparator group caries will be removed from primary molars using sharp excavators then teeth will be restored using glass ionomer filling material at the same visit.
| Study group | Role | What they receive |
|---|---|---|
| SMART | Experimental | Silver modified atraumatic restorative treatment group in which advantage Arrest Silver diamine Fluoride 38% (Elevate oral Care, USA ) will be applied to carious molars then teeth will be restored with GC Fuji IX GP® FAST FAST Packable Posterior Restorative glass ionomer fillings (GC corporation, Tokyo, Japan) Receives: Drug: Silver diamine Fluoride 38% |
| Conventional ART | Active comparator | Conventional atraumatic restorative treatment group in which a sharp excavator will be used to remove caries from carious molars then teeth will be restored with GC Fuji IX GP® FAST FAST Packable Posterior Restorative glass ionomer fillings (GC corporation, Tokyo, Japan) Receives: Procedure: Conventional atraumatic restorative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arresting carious lesion progression and restoration survival
Restorations will be assessed for clinical success and caries arrest in terms of presence of sensitivity, marginal integrity, restoration survival and recurrent caries using United States Public Health Services (USPHS) criteria. Restorations with good color match, good marginal adaptation, no sensitivity and no evidence of caries will be given score alfa (A).
Restorations with slight discoloration, slight discontinuity and diminishing sensitivity will be given score bravo (B). Restorations with unacceptable color, exposed dentin, constant sensitivity and evidence of caries will be given score charlie (C). Restorations fractured or lost will be scored as delta (D).
Measured: 1 year
Secondary outcomes (1)
Patient acceptance
Patient acceptance will be recorded by using self-reported approach to assess the level of child discomfort using the Wong-Baker Facial Scale. The scale shows a series of faces ranging from a happy face to a crying face. The patients will choose the face that best describes their level of pain. The first face represents a pain score of 0 which indicates "no hurt". The second face represents a pain score of 2 which indicates "hurts a little bit." The third face represents a pain score of 4, which indicates "hurts a little more". The fourth face represents a pain score of 6 which indicates "hurts even more". The fifth face represents a pain score of 8 which indicates "hurts a whole lot"; the sixth face represents a pain score of 10 indicating "hurts worst".
Measured: will be recorded immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start3 Aug 2020
- Primary completion3 Nov 2021
- Study completion30 Dec 2021
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.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abla Ahmed Mohamed Aly Ahmed, Ain Shams University
- Investigators
- Abla Ah Aly, A. Lecturer, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881020
- Sponsor's protocol ID
- PED 18-3D
- Status last verified
- Feb 2022
- First submitted
- 11 Mar 2019
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aly AAM, Aziz AMA, Elghazawy RK, El Fadl RKA. Survival Analysis and Cost Effectiveness of Silver Modified Atraumatic Restorative Treatment (SMART) and ART Occlusal Restorations in Primary Molars: a randomized controlled trial. J Dent. 2023 Jan;128:104379. doi: 10.1016/j.jdent.2022.104379. Epub 2022 Nov 29.
PubMed 36460236
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Silver Modified and Conventional Atraumatic Restorative Treatment Modalities in Primary Molars in a Group of Egyptian School Children. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03881020
- Acronym / sponsor ID
- PED 18-3D
- Conditions
- Dental Caries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 3 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 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 study is a randomized controlled trial aiming to compare the effectiveness of Silver modified atraumatic restorative technique and (SMART) and conventional atraumatic restorative technique (ART) regarding their caries arresting properties in primary molars, patient acceptance and cost effectiveness.
Detailed description
5-9 years old school children will be recruited for the study. Parents of eligible children will be informed in full details about the purpose of the study and any possible side effects. Prior to enrollment of children in the study, parents will have to sign a written informed consent outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University. Children will be also informed about the nature of the study using age appropriate language and will have to give an assent to participate before being enrolled in the study.
Children will be clinically examined with the help of a plane dental mirror and an explorer. A single calibrated investigator will undertake all clinical examinations and deliver dental treatment to all patients to ensure standardization. After clinical examination, all children included in the study will be randomly allocated to be one of the two groups either control group (Conventional ART) or experimental group (SMART). Randomization sequence will be electronically generated using (http://randomization.com/). To ensure concealment of allocation, the randomly generated sequence will be concealed and enclosed in sealed, opaque envelopes. The envelopes will be randomly picked up by the children for group allocation. Follow up examinations will be done by a calibrated examiner who was not involved in the treatment procedures. Patients who are no longer willing to continue in the study will have the right to quit at any time without any penalty. All patient information will be collected and recorded in the patient examination chart. All information will be kept as a hard copy and as an electronic copy as well. Patient information will be confidential information that should never be exposed at any point. The data concerning the subjects will be entered into the database with a numerical code only for the purpose of confidentiality.
All data will be tabulated, summarized and statistically analyzed. Data will be statistically described in terms of mean, standard deviation, median and range, or frequencies (number of cases) and percentages when appropriate.
Comparison of numerical variables between the study groups will be done using Student t test for independent samples in comparing normally distributed data and Mann Whitney U test for independent samples when data is not normally distributed. For comparing categorical data, Chi-square test will be performed. Exact test will be used instead when the expected frequency is less than 5.Correlation between various variables will be done using Pearson moment correlation equation for linear relation in normally distributed variables and Spearman rank correlation equation for non-normal variables.
A probability value (p value) less than 0.05 is considered statistically significant. All statistical calculations will be done using computer programs Microsoft Excel 2007 (Microsoft Corporation, NY, USA) and IBM SPSS (Statistical Package for the Social Science; IBM Corp, Armonk, NY, USA) release 22 for Microsoft Windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMART | Experimental | Drug: Silver diamine Fluoride 38%Silver modified atraumatic restorative treatment group in which advantage Arrest Silver diamine Fluoride 38% (Elevate oral Care, USA ) will be applied to carious molars then teeth will be restored with GC Fuji IX GP® FAST FAST Packable Posterior Restorative glass ionomer fillings (GC corporation, Tokyo, Japan) |
| Conventional ART | Active comparator | Procedure: Conventional atraumatic restorative treatmentConventional atraumatic restorative treatment group in which a sharp excavator will be used to remove caries from carious molars then teeth will be restored with GC Fuji IX GP® FAST FAST Packable Posterior Restorative glass ionomer fillings (GC corporation, Tokyo, Japan) |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Medically free children.
- Clinical examination revealing at least one second primary molar with single surface active dentine carious lesions.
- Children who agreed to participate and whose parents signed an informed consent.
- Cooperative or potentially cooperative children according to Wright Classification
Key exclusion criteria (6 listed)
- Children who have known allergies to silver products.
- Children with special health care needs or any medical conditions.
- Children with designated molars having more than one third of their crown missing.
- Children with designated molars showing signs of pulpal pathology such as spontaneous pain, presence of an abscess or sinus or mobility.
- Children with designated molars having an existing restoration.
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 38%Also: Advantage Arrest Silver diamine Fluoride 38%In the intervention group 38% Silver Diamine Fluoride will be applied to the surface of the isolated lesion for a period of 1 minute followed by glass ionomer restoration at the same visit. | Drug | SMART |
| Conventional atraumatic restorative treatmentAlso: ARTIn the active comparator group caries will be removed from primary molars using sharp excavators then teeth will be restored using glass ionomer filling material at the same visit. | Procedure or surgery | Conventional ART |
Primary outcome
Arresting carious lesion progression and restoration survival
Time frame: 1 year
Restorations will be assessed for clinical success and caries arrest in terms of presence of sensitivity, marginal integrity, restoration survival and recurrent caries using United States Public Health Services (USPHS) criteria. Restorations with good color match, good marginal adaptation, no sensitivity and no evidence of caries will be given score alfa (A). Restorations with slight discoloration, slight discontinuity and diminishing sensitivity will be given score bravo (B). Restorations with unacceptable color, exposed dentin, constant sensitivity and evidence of caries will be given score charlie (C). Restorations fractured or lost will be scored as delta (D).
1 secondary outcome
Patient acceptance
Time frame: will be recorded immediately after the procedure
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 23 Feb 2022.
- Derived from this study: PubMed 36460236Aly AAM, Aziz AMA, Elghazawy RK, El Fadl RKA. Survival Analysis and Cost Effectiveness of Silver Modified Atraumatic Restorative Treatment (SMART) and ART Occlusal Restorations in Primary Molars: a randomized controlled trial. J Dent. 2023 Jan;128:104379. doi: 10.1016/j.jdent.2022.104379. Epub 2022 Nov 29.
- 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.
Abla Ah Aly, A. Lecturer principal investigator
Ain Shams 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 Silver diamine Fluoride 38% and Conventional atraumatic restorative treatment in people with Dental Caries, run by Ain Shams 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 4 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: finished, as of the sponsor's last update on 23 Feb 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.
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?
Arresting carious lesion progression and restoration survival (time frame: 1 year). 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 NCT03881020, 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 23 Feb 2022.