AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

Egypt1 site
  • University

    Al Mansurah, El Gomhoria Street, Mansoura,egypt, 35511

Other trials in Egypt

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 groups in NCT05438381
Study groupRoleWhat they receive
ART groupActive comparatorAtraumatic restorative technique: excavation of caries then application of Glass ionomer capsule (GC, USA)
Receives: Procedure: Atraumatic Restorative Technique (ART)
SMART groupExperimentalSMART 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.

  1. post operative pain

    numerical/visual analogue scale 0 no pain 10 worst possible pain

    Measured: 12 months

  2. 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

  3. 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)
  1. tooth mobility

    clinical method of assessing tooth mobility 0 no mobility 3 mobility more than 2 mm bucco-lingually

    Measured: 12 months

  2. 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.

  1. First posted30 Jun 2022
  2. Study start30 Sep 2019
  3. Primary completion30 Oct 2020
  4. Study completion30 Sep 2021

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in