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

Cairo University (CU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Occlusal Caries

Treatments: Other: Atraumatic restorative treatment; Drug: Silver modified atraumatic restorative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04354636

SMART_ART

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Silver modified atraumatic restorative treatment

Experimental group

Description:

Using silver diamine fluoride incorporated with atraumatic restorative treatment

Treatment:

Drug: Silver modified atraumatic restorative treatment

Atraumatic restorative treatment

Active Comparator group

Description:

Using atraumatic restorative treatment without the application of silver diamine fluoride

Treatment:

Other: Atraumatic restorative treatment