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

M

Mansoura University

Status and phase

Completed
Phase 4

Conditions

Caries Arrest

Treatments

Drug: 38 % silver diamine fluoride
Procedure: Atraumatic restorative technique
Procedure: Ultra conservative dentistry

Study type

Interventional

Funder types

Other

Identifiers

NCT05314660
A22080120

Details and patient eligibility

About

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

Full 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.

Enrollment

135 patients

Sex

All

Ages

3 to 5 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

135 participants in 3 patient groups

Silver diamine fluoride group
Experimental group
Description:
Application of 38% SDF.
Treatment:
Drug: 38 % silver diamine fluoride
Atrumatic restorative technique
Experimental group
Treatment:
Procedure: Atraumatic restorative technique
Ultra conservative treatment (UCT)
Experimental group
Treatment:
Procedure: Ultra conservative dentistry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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