Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children
1 other identifier
interventional
135
1 country
1
Brief Summary
Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2020
Typical duration for phase_4
1 active site
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
Study Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedFirst Submitted
Initial submission to the registry
March 24, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2022
CompletedApril 21, 2022
January 1, 2020
2 years
March 24, 2022
April 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.
Absence of pains and signs of pulpal involvement and caries classified as inactive by ICDAS was considered a successful outcome. When the lesions appeared shiny and felt hard on probing (for SDF and UCT). For ART success was measures by the presence of intact restoration and avsence of pain.
1 year
Secondary Outcomes (1)
Early childhood oral health impact scale (ECOHIS)
3 months
Study Arms (3)
Silver diamine fluoride group
EXPERIMENTALApplication of 38% SDF.
Atrumatic restorative technique
EXPERIMENTALUltra conservative treatment (UCT)
EXPERIMENTALInterventions
Application of 38% SDF on carious dentine lesions.
Hand excavation of carious dentine followed by application of Glass ionomer
Removal of soft dentine and enlarging of cavity to control bio film
Eligibility Criteria
You may qualify if:
- healthy children aged 3-5
- residents of mansoura city
- having at least one carious dentine lesion
You may not qualify if:
- large carious lesions approximating the pulp
- signs of pulpitis, fistula, abscess.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Basma Hamza
Al Mansurah, Dakahlia Governorate, 53111, Egypt
Related Publications (1)
Hamza BE, Attia NM, Abdellatif AM, Hegazy SA. Arresting Active Carious Lesions Using Minimal Intervention Dentistry among a Group of Preschool Children: A Randomized Controlled Clinical Trial. Int J Clin Pediatr Dent. 2024 Sep;17(9):1018-1024. doi: 10.5005/jp-journals-10005-2927.
PMID: 39664835DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The operator must know the group in which the participant is enrolled so as to provide and carry out the intended treatment protocol. Randomization was preformed by block randomization by the nurse.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2022
First Posted
April 6, 2022
Study Start
January 15, 2020
Primary Completion
January 15, 2022
Study Completion
March 15, 2022
Last Updated
April 21, 2022
Record last verified: 2020-01