Management of Occlusal Caries Using Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment

April 20, 2020 updated by: Mennatallah Sameh Ahmed Farouk Abdelhamid, Cairo University

Clinical and Radiographic Evaluation After the Use of Silver Modified Atraumatic Restorative Treatment Versus Atraumatic Restorative Treatment in the Management of Occlusal Caries of Primary Molars in Preschool Children: Randomized Clinical Trial

Silver modified atraumatic restorative treatment (intervention) or atraumatic restorative treatment (Control) will be used to manage occlusal caries in preschool children then the molars will be evaluated at the interval of 3,6 and 12 months clinically and 6 and 12 months radiographically

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aim of the study:

To evaluate the clinical and radiographic outcomes after the use of silver modified atraumatic restorative treatment versus atraumatic restorative treatment in the management of occlusal caries in primary molars in preschool children.

PICO:

Population:

Preschool children (4-6 years) with occlusal caries in second primary molars.

Intervention:

Silver modified atraumatic restorative treatment

Comparator/Control:

Atraumatic restorative treatment.

Outcomes:

Pain (provoked or spontaneous) OHRQoL(oral health related to quality of life) Parental esthetic perception Failure of restoration Caries density in radiograph

Time:

3, 6 and 12 months

Study design:

A randomized clinical trial

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sherif B El Tawil, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Patient and parent cooperation and compliance.

    • Children aged 4 - 6 years
    • Second primary molars with occlusal caries.
    • No clinical signs and symptoms of pulp involvement
    • No radiographic abnormalities

Exclusion Criteria:

  • • Uncooperative children or parents

    • Children with systemic diseases
    • Children with previous allergies to any of the used materials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silver modified atraumatic restorative treatment
Using silver diamine fluoride incorporated with atraumatic restorative treatment
Drug: Silver modified atraumatic restorative treatment
Silver diamine fluoride that will be applied during atraumatic restorative treatment
Active Comparator: Atraumatic restorative treatment
Using atraumatic restorative treatment without the application of silver diamine fluoride
Other: Atraumatic restorative treatment
Using atraumatic restorative treatment without applying silver diamine fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous)
Time Frame: 12 months
Pain reported-Pain history that occurs after treatment at any point (will be recorded at the follow up intervals) Outcome will be binary (yes/no)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHRQoL(oral health related to quality of life)
Time Frame: 3 months
The Early Childhood Oral Health Impact Scale (A-ECOHIS) Score 0-52. There will be 13 questions each question with a score 0-5 where 0 = excellent, 1=very good, 2=good, 3=fair , 4=poor and 5= unknown so the less the score the better is the oral health related to quality of life.
3 months
Questioning parents about their aesthetic perception
Time Frame: 3 months
Parent reported (parent is asked whether he/she is accepting the tooth appearance or not) Outcome will be binary (yes/no)
3 months
ART assessment criteria (Codes 00-90)
Time Frame: 12 months

Failure of restoration according to the code in the ART assessment criteria (Codes 00-90).

Code 00 or 10 are considered successful, codes 11-40 are classified as failures, and codes 50-90 are assigned in case the tooth was unavailable for evaluation
12 months
Caries density in radiograph
Time Frame: 12 months
Pixel grey value
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Sherif B El Tawil, Professor, Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university
  • Study Director: Dalia M Moheb, Associate professor, Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SMART_ART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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