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.

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

Study Overview

• Status: Completed
• Conditions: Caries Arrest
• Intervention / Treatment: Drug: 38 % silver diamine fluoride; Procedure: Atraumatic restorative technique; Procedure: Ultra conservative dentistry

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.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 53111
      • Basma Hamza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Silver diamine fluoride group; Application of 38% SDF.	Drug: 38 % silver diamine fluoride; Application of 38% SDF on carious dentine lesions.
Experimental: Atrumatic restorative technique	Procedure: Atraumatic restorative technique; Hand excavation of carious dentine followed by application of Glass ionomer
Experimental: Ultra conservative treatment (UCT)	Procedure: Ultra conservative dentistry; Removal of soft dentine and enlarging of cavity to control bio film

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early childhood oral health impact scale (ECOHIS)	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.	3 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): January 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: April 3, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: A22080120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data regarding the A-ECOHIS will be available to share if needed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes