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NCT Number: NCT04354636

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

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

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Key information

Conditions

Occlusal Caries

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty's pediatric dentiatry clinic

Cairo, Gizq, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Silver modified atraumatic restorative treatment

Drug

Silver diamine fluoride that will be applied during atraumatic restorative treatment

Atraumatic restorative treatment

Other

Using atraumatic restorative treatment without applying silver diamine fluoride

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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. 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

  4. Caries density in radiograph

    Time frame: 12 months

    Pixel grey value

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 21, 2020
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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