Clinical trial NCT05337449: Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique
Official title: Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Health Related Quality of Life
Early Childhood Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: for both the intervention group and control group, the procedure and follow up will be done parallel to each other
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Oral Health to Quality of Life
timeFrame: 6 month intervene
Secondary outcomes:
measure: The cost effectiveness
timeFrame: 6 month intervene
measure: Parental satisfaction
timeFrame: 6 month intervene
measure: Side effects
timeFrame: 6 month intervene
measure: Time of the procedure
timeFrame: 6 month intervene
measure: Postoperative pain and sensitivity
timeFrame: 6 month intervene
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Gala Osman, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Sherine Younes, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Passant Nagii, PHD
role: STUDY_DIRECTOR
References: