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

Phase 4

Completed

• Conditions: Caries Arrest
• Interventions: Drug: 38 % silver diamine fluoride; Procedure: Atraumatic restorative technique; Procedure: Ultra conservative dentistry

• Registration Number: NCT05314660
• Lead Sponsor: Mansoura University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-15
• Primary Completion: 2022-01-15
• Study Completion: 2022-03-15
• Study First Submitted: 2022-03-24
• Study First Submitted QC: 2022-04-03
• Study First Posted: 2022-04-06
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silver diamine fluoride group	38 % silver diamine fluoride	Application of 38% SDF.
Atrumatic restorative technique	Atraumatic restorative technique	-
Ultra conservative treatment (UCT)	Ultra conservative dentistry	-

Primary Outcome Measures

Name	Time	Method
Caries arrestment assessed by the International caries detection and assessment system (ICDAS) and absence of pain and signs of pulpal involvement.	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 Outcome Measures

Name	Time	Method
Early childhood oral health impact scale (ECOHIS)	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.

Trial Locations

Locations (1)

Basma Hamza; 🇪🇬 Mansoura, Dakahlia, Egypt