Dental CariesNCT05438381
Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars
A study testing Atraumatic Restorative Technique (ART) and SMART Technique in people with Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
This study conducted on thirty children aged 3-6 years old of both genders, have bilateral carious lower first primary molars. Pre-operative periapical x- ray were taken for both sides. The children were divided into 2 groups(SMART group and ART group). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Atraumatic Restorative Technique (ART) and SMART Technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2019to 30 Sep 2021
- 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 Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- This study conducted on thirty children aged 3-6 years old of both genders.
- children in the study were. Apparent healthy and free from any systemic diseases or chronic conditions.
- Child should have bilateral restorable carious lower first primary molars, occlusal caries, ICDAS score (4, 5), asymptomatic or have reversible pulpitis.
- Radiographic examination show intact lamina dura, absence of internal and external pathological root resorption or periapical infection.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assistant Lecturer of Pediatric Dentistry, Mansoura University (2019)
This study conducted on thirty children aged 3-6 years old of both genders, have bilateral carious lower first primary molars. Pre-operative periapical x- ray were taken for both sides. The children were divided into 2 groups(SMART group and ART group). For Atraumatic Restorative Technique (ART technique), glass ionomer cement(GIC) was applied according to manufacturer's instructions. For Silver Modified Atraumatic Restorative Technique (SMART technique), SDF was applied carefully using bended micro sponge brush. It was applied directly to only the affected tooth surface. After one week GIC was applied according to manufacturer's instructions. Clinical and radiographic evaluation were done for all teeth at 6, 12 months. The data were collected then statistically analyzed using chi-square test to show the difference between groups.
Read the detailed description
Sample size calculation:
For this study, a sample size of 30 was obtained using unpaired two sample two tail z-test. The effect size (dz=2.813) and the required sample size were calculated for α =0.05 and a confidence power of 0.8039, assuming a normal distribution.
Patient selection: This study conducted on thirty children aged 3-6 years old of both genders. The children selected from Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. Included children in the study were. Apparent healthy and free from any systemic diseases or chronic conditions. Child should have bilateral restorable carious lower first primary molars, occlusal caries, International Caries Detection and Assessment System(ICDAS) score (4, 5), asymptomatic or have reversible pulpitis. Radiographic examination show intact lamina dura, absence of internal and external pathological root resorption or periapical infection.
Randomization. The study was spilt mouth design. The right side of all participants was done atraumatic restorative technique (ART) and the left side was silver modified atraumatic restorative technique (SMART technique).
Clinical procedures:
- Communication with the children were established.
- Pre-operative periapical x- ray were taken for both sides.
- Gross debris from cavitation were removed.
- Carious dentin on walls were excavated using spoon excavator and low speed contra with round or fissure bur.
- Areas to be treated were isolated with cotton rolls.
- Dryness of lesion with gentle flow of compressed air were done. Control group: Right side of the patient (ART technique) (group 1) (D1) :(20)
- GIC was applied according to manufacturer's instructions.
Experimental group: Left side of the patient (SMART technique) (group 2) (D2):(21)
- A protective coating was applied to the lips and skin to prevent a temporary henna-appearing tattoo that can occur if soft tissues come into contact with SDF.
- SDF was applied carefully using bended micro sponge brush. The brush was dipped into SDF and dabbed on the side of the plastic dish to remove excess liquid before application.
- SDF was applied directly to only the affected tooth surface of lower first primary molar.
- Excess SDF was removed with gauze, cotton roll, or cotton pellet to minimize systemic absorption.
- Application time was at least one minute. No more than one drop of SDF was used for the entire appointment.
- The lesion was dried for 15 seconds with gentle flow of compressed air.
- After one week GIC was applied according to manufacturer's instructions.
Evaluation:
All primary molars were evaluated clinically and radiographically at 6 and 12 months for the overall success/failure criteria:
- Presence/absence of {recurrent caries (catch with probe), pain (spontaneous, with eating, with percussion), clinical abscess, mobility}.
- Presence/absence of {internal root resorption, external root resorption, interradicular radiolucency, periapical radiolucency}.
Statistical Analysis:
The collected data were tabulated and statistically analyzed . The results were considered statistically significant at p≤0.05.
- Chi-Square test was performed to compare the significance between the groups in clinical and radiographic evaluation.
- Kappa index was performed to correlate between clinical and radiographic results.
- Conditions
- Dental Caries
- Being tested
- Atraumatic Restorative Technique (ART), SMART Technique
- Keywords
- 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.
Atraumatic Restorative Technique (ART)Procedure or surgery
Glass ionomer capsule (GC, USA)
SMART TechniqueProcedure or surgery
silver diamine fluoride (SDF) then glass ionomer cement capsule (GC, USA)
| Study group | Role | What they receive |
|---|---|---|
| ART group | Active comparator | Atraumatic restorative technique: excavation of caries then application of Glass ionomer capsule (GC, USA) Receives: Procedure: Atraumatic Restorative Technique (ART) |
| SMART group | Experimental | SMART technique: excavation of caries and application of silver diamine fluoride (SDF 38%) then glass ionomer cement Receives: Procedure: SMART Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain
numerical/visual analogue scale 0 no pain 10 worst possible pain
Measured: 12 months
radiolucency
x ray will be done( qualitative assessment looking for presence of interradicular or periapical radiolucency will be performed and will be scored as yes or no)
Measured: 12 months
Pathological internal or external root resorption
x ray will be done( qualitative assessment looking for presence of pathological internal or external root resorption will be performed and will be scored as yes or no)
Measured: 12 months
Secondary outcomes (2)
tooth mobility
clinical method of assessing tooth mobility 0 no mobility 3 mobility more than 2 mm bucco-lingually
Measured: 12 months
Presence or absence of fistula
visual inspection( visual assessment will be performed clinically looking for presence or absence and will be scored yes or no)
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 posted30 Jun 2022
- Study start30 Sep 2019
- Primary completion30 Oct 2020
- Study completion30 Sep 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 Mansoura 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sahar mohammed, dentist, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438381
- Sponsor's protocol ID
- A 04030919
- Status last verified
- Jun 2022
- First submitted
- 10 May 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Contreras V, Toro MJ, Elias-Boneta AR, Encarnacion-Burgos A. Effectiveness of silver diamine fluoride in caries prevention and arrest: a systematic literature review. Gen Dent. 2017 May-Jun;65(3):22-29.
PubMed 28475081
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assistant Lecturer of Pediatric Dentistry, Mansoura University (2019)
- ClinicalTrials.gov ID
- NCT05438381
- Acronym / sponsor ID
- A 04030919
- Conditions
- Dental Caries
- Keywords
- SDF, ART, SMART technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 30 Jun 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 conducted on thirty children aged 3-6 years old of both genders, have bilateral carious lower first primary molars. Pre-operative periapical x- ray were taken for both sides. The children were divided into 2 groups(SMART group and ART group). For Atraumatic Restorative Technique (ART technique), glass ionomer cement(GIC) was applied according to manufacturer's instructions. For Silver Modified Atraumatic Restorative Technique (SMART technique), SDF was applied carefully using bended micro sponge brush. It was applied directly to only the affected tooth surface. After one week GIC was applied according to manufacturer's instructions. Clinical and radiographic evaluation were done for all teeth at 6, 12 months. The data were collected then statistically analyzed using chi-square test to show the difference between groups.
Detailed description
Sample size calculation:
For this study, a sample size of 30 was obtained using unpaired two sample two tail z-test. The effect size (dz=2.813) and the required sample size were calculated for α =0.05 and a confidence power of 0.8039, assuming a normal distribution.
Patient selection: This study conducted on thirty children aged 3-6 years old of both genders. The children selected from Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. Included children in the study were. Apparent healthy and free from any systemic diseases or chronic conditions. Child should have bilateral restorable carious lower first primary molars, occlusal caries, International Caries Detection and Assessment System(ICDAS) score (4, 5), asymptomatic or have reversible pulpitis. Radiographic examination show intact lamina dura, absence of internal and external pathological root resorption or periapical infection.
Randomization. The study was spilt mouth design. The right side of all participants was done atraumatic restorative technique (ART) and the left side was silver modified atraumatic restorative technique (SMART technique).
Clinical procedures:
- Communication with the children were established.
- Pre-operative periapical x- ray were taken for both sides.
- Gross debris from cavitation were removed.
- Carious dentin on walls were excavated using spoon excavator and low speed contra with round or fissure bur.
- Areas to be treated were isolated with cotton rolls.
- Dryness of lesion with gentle flow of compressed air were done. Control group: Right side of the patient (ART technique) (group 1) (D1) :(20)
- GIC was applied according to manufacturer's instructions.
Experimental group: Left side of the patient (SMART technique) (group 2) (D2):(21)
- A protective coating was applied to the lips and skin to prevent a temporary henna-appearing tattoo that can occur if soft tissues come into contact with SDF.
- SDF was applied carefully using bended micro sponge brush. The brush was dipped into SDF and dabbed on the side of the plastic dish to remove excess liquid before application.
- SDF was applied directly to only the affected tooth surface of lower first primary molar.
- Excess SDF was removed with gauze, cotton roll, or cotton pellet to minimize systemic absorption.
- Application time was at least one minute. No more than one drop of SDF was used for the entire appointment.
- The lesion was dried for 15 seconds with gentle flow of compressed air.
- After one week GIC was applied according to manufacturer's instructions.
Evaluation:
All primary molars were evaluated clinically and radiographically at 6 and 12 months for the overall success/failure criteria:
- Presence/absence of {recurrent caries (catch with probe), pain (spontaneous, with eating, with percussion), clinical abscess, mobility}.
- Presence/absence of {internal root resorption, external root resorption, interradicular radiolucency, periapical radiolucency}.
Statistical Analysis:
The collected data were tabulated and statistically analyzed . The results were considered statistically significant at p≤0.05.
- Chi-Square test was performed to compare the significance between the groups in clinical and radiographic evaluation.
- Kappa index was performed to correlate between clinical and radiographic results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ART group | Active comparator | Procedure: Atraumatic Restorative Technique (ART)Atraumatic restorative technique: excavation of caries then application of Glass ionomer capsule (GC, USA) |
| SMART group | Experimental | Procedure: SMART TechniqueSMART technique: excavation of caries and application of silver diamine fluoride (SDF 38%) then glass ionomer cement |
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- This study conducted on thirty children aged 3-6 years old of both genders.
- children in the study were. Apparent healthy and free from any systemic diseases or chronic conditions.
- Child should have bilateral restorable carious lower first primary molars, occlusal caries, ICDAS score (4, 5), asymptomatic or have reversible pulpitis.
- Radiographic examination show intact lamina dura, absence of internal and external pathological root resorption or periapical infection.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Atraumatic Restorative Technique (ART)Glass ionomer capsule (GC, USA) | Procedure or surgery | ART group |
| SMART Techniquesilver diamine fluoride (SDF) then glass ionomer cement capsule (GC, USA) | Procedure or surgery | SMART group |
Primary outcome
post operative pain
Time frame: 12 months
numerical/visual analogue scale 0 no pain 10 worst possible pain
radiolucency
Time frame: 12 months
x ray will be done( qualitative assessment looking for presence of interradicular or periapical radiolucency will be performed and will be scored as yes or no)
Pathological internal or external root resorption
Time frame: 12 months
x ray will be done( qualitative assessment looking for presence of pathological internal or external root resorption will be performed and will be scored as yes or no)
2 secondary outcomes
tooth mobility
Time frame: 12 months
Presence or absence of fistula
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 Jun 2022.
- Background: PubMed 28475081Contreras V, Toro MJ, Elias-Boneta AR, Encarnacion-Burgos A. Effectiveness of silver diamine fluoride in caries prevention and arrest: a systematic literature review. Gen Dent. 2017 May-Jun;65(3):22-29.
- Individual participant dataSharing planned: No
Related trials for Dental Caries
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
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
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.
sahar mohammed, dentist principal investigator
Mansoura 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 Atraumatic Restorative Technique (ART) and SMART Technique in people with Dental Caries, run by Mansoura 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 1 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 Jun 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?
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?
post operative pain (time frame: 12 months). The study lists 3 primary outcomes in all. 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 NCT05438381, 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 30 Jun 2022.