Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Caries Arrest

Treatments: Drug: 38 % silver diamine fluoride; Procedure: Atraumatic restorative technique; Procedure: Ultra conservative dentistry

Study type: Interventional

Funder types: Other

Identifiers

NCT05314660

A22080120

Details and patient eligibility

About

Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.

Full description

135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS.

The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.

Enrollment: 135 patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy children aged 3-5
• residents of mansoura city
• having at least one carious dentine lesion

Exclusion criteria

• large carious lesions approximating the pulp
• signs of pulpitis, fistula, abscess.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 3 patient groups

Silver diamine fluoride group

Experimental group

Description:

Application of 38% SDF.

Treatment:

Drug: 38 % silver diamine fluoride

Atrumatic restorative technique

Experimental group

Treatment:

Procedure: Atraumatic restorative technique

Ultra conservative treatment (UCT)

Experimental group

Treatment:

Procedure: Ultra conservative dentistry