Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique
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
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJune 15, 2022
April 1, 2022
6 months
April 14, 2022
June 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Oral Health to Quality of Life
will be evaluated by a questioner answered by the parents
6 month intervene
Secondary Outcomes (5)
The cost effectiveness
6 month intervene
Parental satisfaction
6 month intervene
Side effects
6 month intervene
Time of the procedure
6 month intervene
Postoperative pain and sensitivity
6 month intervene
Study Arms (2)
silver diamine fluoride
ACTIVE COMPARATORconventional composite resin restoration
ACTIVE COMPARATORInterventions
silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Unable to attend follow-up visits.
- Refusal of participation.
- Previously accessed teeth.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Gala Osman, BDS
Cairo University
- STUDY DIRECTOR
Sherine Younes, Professor
Cairo University
- STUDY DIRECTOR
Passant Nagii, PHD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 20, 2022
Study Start
July 15, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2023
Last Updated
June 15, 2022
Record last verified: 2022-04