Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique

Not Applicable

• Conditions: Early Childhood Caries; Oral Health Related Quality of Life
• Interventions: Other: silver diamine fluoride; Other: conventional composite resin restoration

• Registration Number: NCT05337449
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-14
• Study First Posted: 2022-04-20
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15
• Study Start: 2022-07-15
• Primary Completion: 2022-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silver diamine fluoride	conventional composite resin restoration	-
conventional composite resin restoration	conventional composite resin restoration	-
silver diamine fluoride	silver diamine fluoride	-
conventional composite resin restoration	silver diamine fluoride	-

Primary Outcome Measures

Name	Time	Method
Oral Health to Quality of Life	6 month intervene	will be evaluated by a questioner answered by the parents

Secondary Outcome Measures

Name	Time	Method
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