search
Back to results

Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Atraumatic Restorative Technique (ART)
SMART Technique
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring SDF, ART, SMART technique

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Accepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Sites / Locations

  • University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ART group

SMART group

Arm Description

Atraumatic restorative technique: excavation of caries then application of Glass ionomer capsule (GC, USA)

SMART technique: excavation of caries and application of silver diamine fluoride (SDF 38%) then glass ionomer cement

Outcomes

Primary Outcome Measures

post operative pain
numerical/visual analogue scale 0 no pain 10 worst possible pain
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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2022
Last Updated
June 24, 2022
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT05438381
Brief Title
Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars
Official Title
Assistant Lecturer of Pediatric Dentistry, Mansoura University (2019)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
SDF, ART, SMART technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART group
Arm Type
Active Comparator
Arm Description
Atraumatic restorative technique: excavation of caries then application of Glass ionomer capsule (GC, USA)
Arm Title
SMART group
Arm Type
Experimental
Arm Description
SMART technique: excavation of caries and application of silver diamine fluoride (SDF 38%) then glass ionomer cement
Intervention Type
Procedure
Intervention Name(s)
Atraumatic Restorative Technique (ART)
Intervention Description
Glass ionomer capsule (GC, USA)
Intervention Type
Procedure
Intervention Name(s)
SMART Technique
Intervention Description
silver diamine fluoride (SDF) then glass ionomer cement capsule (GC, USA)
Primary Outcome Measure Information:
Title
post operative pain
Description
numerical/visual analogue scale 0 no pain 10 worst possible pain
Time Frame
12 months
Title
radiolucency
Description
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)
Time Frame
12 months
Title
Pathological internal or external root resorption
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
tooth mobility
Description
clinical method of assessing tooth mobility 0 no mobility 3 mobility more than 2 mm bucco-lingually
Time Frame
12 months
Title
Presence or absence of fistula
Description
visual inspection( visual assessment will be performed clinically looking for presence or absence and will be scored yes or no)
Time Frame
12 months

10. Eligibility

Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sahar mohammed, dentist
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University
City
Mansoura
State/Province
El Gomhoria Street, Mansoura,egypt
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28475081
Citation
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.
Results Reference
background

Learn more about this trial

Comparison of Clinical and Radiographic Outcomes of SMART Technique vs ART in Primary Molars

We'll reach out to this number within 24 hrs