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

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

Detailed Description
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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.

Official Title
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Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.

Conditions
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Caries Arrest

Intervention / Treatment
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* Drug: 38 % silver diamine fluoride
* Procedure: Atraumatic restorative technique
* Procedure: Ultra conservative dentistry


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 equal groups receiving 3 different protocols
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver diamine fluoride group<br>Application of 38% SDF. | Drug: 38 % silver diamine fluoride<br>* Application of 38% SDF on carious dentine lesions.<br>|
| Experimental: Atrumatic restorative technique<br> | Procedure: Atraumatic restorative technique<br>* Hand excavation of carious dentine followed by application of Glass ionomer<br>|
| Experimental: Ultra conservative treatment (UCT)<br> | Procedure: Ultra conservative dentistry<br>* Removal of soft dentine and enlarging of cavity to control bio film<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement. | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early childhood oral health impact scale (ECOHIS) | Comprises 13 questions of four domains; child symptoms, function, pscychology and social interactions. Questionnaire answered at the first appointment and 21 days later. Lowest score is 0, highest is 52 and higher score indicates poor oral health related quality of life. | 3 months |