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Completed

NCT Number: NCT05314660

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

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

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Key information

Conditions

Caries Arrest

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Basma Hamza

Al Mansurah, Dakahlia Governorate, 53111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

38 % silver diamine fluoride

Drug

Application of 38% SDF on carious dentine lesions.

Atraumatic Restorative Technique

Procedure

Hand excavation of carious dentine followed by application of Glass ionomer

Ultra conservative dentistry

Procedure

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

Primary outcomes

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

    Time frame: 1 year

    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.

Secondary outcomes

  1. Early childhood oral health impact scale (ECOHIS)

    Time frame: 3 months

    Comprises 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.