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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silver modified atraumatic restorative treatment | Experimental | Using silver diamine fluoride incorporated with atraumatic restorative treatment |
|
| Atraumatic restorative treatment | Active Comparator | Using atraumatic restorative treatment without the application of silver diamine fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silver modified atraumatic restorative treatment | Drug | Silver diamine fluoride that will be applied during atraumatic restorative treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Questioning parent about whether the child have pain between follow up intervals (provoked or spontaneous) | 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| OHRQoL(oral health related to quality of life) | 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. | 3 months |
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Inclusion Criteria:
• Patient and parent cooperation and compliance.
Exclusion Criteria:
• Uncooperative children or parents
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| Name | Affiliation | Role |
|---|---|---|
| Sherif B El Tawil, Professor | Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university | Study Director |
| Dalia M Moheb, Associate professor | Pediatric Dentistry & Dental Public Health Faculty of Dentistry , Cairo university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty's pediatric dentiatry clinic | Cairo | Gizq | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31279925 | Background | Vollu AL, Rodrigues GF, Rougemount Teixeira RV, Cruz LR, Dos Santos Massa G, de Lima Moreira JP, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment on dentine caries arrestment in primary molars of preschool children: A 12-months parallel randomized controlled clinical trial. J Dent. 2019 Sep;88:103165. doi: 10.1016/j.jdent.2019.07.003. Epub 2019 Jul 4. | |
| 30866534 |
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| Atraumatic restorative treatment | Other | Using atraumatic restorative treatment without applying silver diamine fluoride |
|
| Questioning parents about their aesthetic perception |
Parent reported (parent is asked whether he/she is accepting the tooth appearance or not) Outcome will be binary (yes/no) |
| 3 months |
| ART assessment criteria (Codes 00-90) | 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 | 12 months |
| Caries density in radiograph | Pixel grey value | 12 months |
| Background |
| Saber AM, El-Housseiny AA, Alamoudi NM. Atraumatic Restorative Treatment and Interim Therapeutic Restoration: A Review of the Literature. Dent J (Basel). 2019 Mar 7;7(1):28. doi: 10.3390/dj7010028. |
| 29874642 | Background | Oliveira BH, Rajendra A, Veitz-Keenan A, Niederman R. The Effect of Silver Diamine Fluoride in Preventing Caries in the Primary Dentition: A Systematic Review and Meta-Analysis. Caries Res. 2019;53(1):24-32. doi: 10.1159/000488686. Epub 2018 Jun 6. |
| 17710452 | Background | van Gemert-Schriks MC, van Amerongen WE, ten Cate JM, Aartman IH. Three-year survival of single- and two-surface ART restorations in a high-caries child population. Clin Oral Investig. 2007 Dec;11(4):337-43. doi: 10.1007/s00784-007-0138-8. Epub 2007 Aug 21. |
| ID | Term |
|---|---|
| D057087 | Dental Atraumatic Restorative Treatment |
| ID | Term |
|---|---|
| D003813 | Dentistry |
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