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Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children

Arresting Active Dentine Lesions and Quality of Life Among a Group of Preschool Children in Mansoura City.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05314660
Enrollment
135
Registered
2022-04-06
Start date
2020-01-15
Completion date
2022-03-15
Last updated
2022-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries Arrest

Brief summary

Testing 3 different caries arresting techniques and the quality of life of a group of preschool children in Mansoura city, Egypt.

Detailed description

135 preschoolers were allocated randomly into 3 groups to receive 3 techniques to evaluate caries arrestment. The first group received 38% silver diamine fluoride, the second received conventional Atraumatic restorative technique and the third group received ultra consevative treatment (UCT). The subjects were followed up at 3, 6 and 12 months to check caries activity according to the ICDAS. The parents of the children answered the Arabic ECOHIS before treatment and after 3 months to assess oral health related quality of life.

Interventions

DRUG38 % silver diamine fluoride

Application of 38% SDF on carious dentine lesions.

Hand excavation of carious dentine followed by application of Glass ionomer

PROCEDUREUltra conservative dentistry

Removal of soft dentine and enlarging of cavity to control bio film

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

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.

Intervention model description

3 equal groups receiving 3 different protocols

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy children aged 3-5 * residents of mansoura city * having at least one carious dentine lesion

Exclusion criteria

* large carious lesions approximating the pulp * signs of pulpitis, fistula, abscess.

Design outcomes

Primary

MeasureTime frameDescription
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.1 yearAbsence 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.

Secondary

MeasureTime frameDescription
Early childhood oral health impact scale (ECOHIS)3 monthsComprises 13 questions of four domains; child symptoms, function, pscychology and social interactions. Questionnaire answered at the first appointment and 21 days later. Lowest score is 0, highest is 52 and higher score indicates poor oral health related quality of life.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026