Oral Health-Related Quality of Life of Early Childhood Caries Using Silver Diamine Fluoride Versus Drill and Fill Technique

Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial

The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC

Study Overview

• Status: Not yet recruiting
• Conditions: Early Childhood Caries; Oral Health Related Quality of Life
• Intervention / Treatment: Other: silver diamine fluoride; Other: conventional composite resin restoration

Detailed Description

Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".

Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gala Osman, BDS; Phone Number: +201147456003; Email: gala.osman@dentistry.cu.edu.eg
• Study Contact Backup: Name: Passant Nagi, PHD; Phone Number: +201280557107; Email: Passant.nagi@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children Aged 3 to 5 years, in good general health and medically within normal.
• The parents provided written informed consent.
• Carious vital primary molars with reversible pulpitis.
• Restorable teeth.
• Normal Radiographic findings.

Exclusion Criteria:

• Unable to attend follow-up visits.
• Refusal of participation.
• Previously accessed teeth.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: silver diamine fluoride	Other: silver diamine fluoride; silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries; Other: conventional composite resin restoration; Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.
Active Comparator: conventional composite resin restoration	Other: silver diamine fluoride; silver diamine fluoride is a colorless with high PH topical fluoride solution of 38% weight/volume use for arresting early childhood caries; Other: conventional composite resin restoration; Dental composite resins are dental cement made of synthetic resins which were insoluble, of good tooth-like appearance, insensitive to dehydration, and easy to manipulate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral Health to Quality of Life	will be evaluated by a questioner answered by the parents	6 month intervene

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cost effectiveness	will be measured using ICER (incremental cost-effectiveness ratio)	6 month intervene
Parental satisfaction	will be measured by Direct questioning to the parents.	6 month intervene
Side effects	will be measured by Direct questioning to the parents.	6 month intervene
Time of the procedure	will be measured by stopwatch	6 month intervene
Postoperative pain and sensitivity	will be measured by Visual analogue scale	6 month intervene

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Gala Osman, BDS, Cairo University; Study Director: Sherine Younes, Professor, Cairo University; Study Director: Passant Nagii, PHD, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: OHrQL in ECC treated with SDF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No