Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.
Overview
- Phase
- Phase 4
- Intervention
- 38 % silver diamine fluoride
- Conditions
- Caries Arrest
- Sponsor
- Mansoura University
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.
Detailed 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Silver diamine fluoride group
Application of 38% SDF.
Intervention: 38 % silver diamine fluoride
Atrumatic restorative technique
Intervention: Atraumatic restorative technique
Ultra conservative treatment (UCT)
Intervention: Ultra conservative dentistry
Outcomes
Primary Outcomes
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
Time Frame: 1 year
Absence of pains and signs of pulpal involvement and caries classified as inactive by ICDAS was considered a successful outcome. When the lesions appeared shiny and felt hard on probing (for SDF and UCT). For ART success was measures by the presence of intact restoration and avsence of pain.
Secondary Outcomes
- Early childhood oral health impact scale (ECOHIS)(3 months)