Early Childhood Caries, Oral Health Related Quality of Life
Conditions
Brief summary
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
Detailed description
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.
Interventions
OTHERsilver diamine fluoride
silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries
OTHERconventional composite resin restoration
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
for both the intervention group and control group, the procedure and follow up will be done parallel to each other
Eligibility
Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* Children Aged 3 to 5 years, in good general health and medically within normal. * The parents provided written informed consent. * Carious vital primary molars with reversible pulpitis. * Restorable teeth. * Normal Radiographic findings.
Exclusion criteria
* Unable to attend follow-up visits. * Refusal of participation. * Previously accessed teeth.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral Health to Quality of Life | 6 month intervene | will be evaluated by a questioner answered by the parents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The cost effectiveness | 6 month intervene | will be measured using ICER (incremental cost-effectiveness ratio) |
| Parental satisfaction | 6 month intervene | will be measured by Direct questioning to the parents. |
| Side effects | 6 month intervene | will be measured by Direct questioning to the parents. |
| Time of the procedure | 6 month intervene | will be measured by stopwatch |
| Postoperative pain and sensitivity | 6 month intervene | will be measured by Visual analogue scale |
Contacts
Primary ContactGala Osman, BDS
Backup ContactPassant Nagi, PHD
Outcome results
None listed