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The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC
Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".
Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silver diamine fluoride | Active Comparator |
| |
| conventional composite resin restoration | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silver diamine fluoride | Other | silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral Health to Quality of Life | will be evaluated by a questioner answered by the parents | 6 month intervene |
| Measure | Description | Time Frame |
|---|---|---|
| The cost effectiveness | will be measured using ICER (incremental cost-effectiveness ratio) | 6 month intervene |
| Parental satisfaction | will be measured by Direct questioning to the parents. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gala Osman, BDS | Contact | +201147456003 | gala.osman@dentistry.cu.edu.eg | |
| Passant Nagi, PHD | Contact | +201280557107 | passant.nagi@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Gala Osman, BDS | Cairo University | Principal Investigator |
| Sherine Younes, Professor | Cairo University | Study Director |
| Passant Nagii, PHD |
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for both the intervention group and control group, the procedure and follow up will be done parallel to each other
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| conventional composite resin restoration | Other | Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate. |
|
| 6 month intervene |
| Side effects | will be measured by Direct questioning to the parents. | 6 month intervene |
| Time of the procedure | will be measured by stopwatch | 6 month intervene |
| Postoperative pain and sensitivity | will be measured by Visual analogue scale | 6 month intervene |
| Cairo University |
| Study Director |
| ID | Term |
|---|---|
| C024633 | silver diamine fluoride |
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