NCT05438381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

May 10, 2022

Last Update Submit

June 24, 2022

Conditions

Dental Caries

Keywords

SDFARTSMART technique

Outcome Measures

Primary Outcomes (3)

  • post operative pain

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

    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)

    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)

    12 months

Secondary Outcomes (2)

  • tooth mobility

    12 months

  • Presence or absence of fistula

    12 months

Study Arms (2)

ART group

ACTIVE COMPARATOR

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

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

Procedure: SMART Technique

Interventions

Atraumatic Restorative Technique (ART)PROCEDURE

Glass ionomer capsule (GC, USA)

ART group
SMART TechniquePROCEDURE

silver diamine fluoride (SDF) then glass ionomer cement capsule (GC, USA)

SMART group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

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

Location

Related Publications (1)

  • 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.

    PMID: 28475081BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • sahar mohammed, dentist

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2022

First Posted

June 30, 2022

Study Start

September 30, 2019

Primary Completion

October 30, 2020

Study Completion

September 30, 2021

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)