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

Early Childhood Caries Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05337449
• Other study ID #: OHrQL in ECC treated with SDF
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: Cairo University
• Contact: Gala Osman, BDS
• Phone: +201147456003
• Email: gala.osman[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Other:
• silver diamine fluoride
silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries
• conventional 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Health to Quality of Life	will be evaluated by a questioner answered by the parents	6 month intervene
Secondary	The cost effectiveness	will be measured using ICER (incremental cost-effectiveness ratio)	6 month intervene
Secondary	Parental satisfaction	will be measured by Direct questioning to the parents.	6 month intervene
Secondary	Side effects	will be measured by Direct questioning to the parents.	6 month intervene
Secondary	Time of the procedure	will be measured by stopwatch	6 month intervene
Secondary	Postoperative pain and sensitivity	will be measured by Visual analogue scale	6 month intervene