Effectiveness of SDF With Different Post-treatment Protocols in Arresting Dental Caries

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of the semi-annual application of 38% SDF with two post-treatment protocols in arresting dental caries in preschool children

Detailed Description
-----------------
Methods: The randomized double blinded clinical trial will recruit 254 healthy kindergarten children aged 3-5 years old with caries and with parental consent. All the tooth surfaces with carious lesions will receive the semi-annual application of 38% SDF solution. After the treatment, children will be allocated to two groups by an independent research assistant. Two post-treatment protocols are as follows. Group A - Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children. Group B - Children are instructed not to eat and drink for at least 30 minutes. Clinical examinations after 6-months will be conducted to assess whether the caries is arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and 12-months follow-up. The examiner, the children and the children's parents will be blind to the treatment allocation. The analysis will determine the significance of differences between the means of arrested caries at the various follow-ups. Significance: This study will help determine the optimal post-op treatment in SDF treatment. The study provides an evidence-based protocol for the use of silver diamine fluoride to arrest tooth decay in primary teeth of young children.

Official Title
-----------------
The Effectiveness of Silver Diamine Fluoride Treatment With Different Post-treatment Protocols in Arresting Dental Caries in Primary Teeth of Preschool Children

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: 38% SDF treatment
* Behavioral: not to rinse for at least 30 minutes after SDF treatment
* Behavioral: rinse mouth immediately after SDF treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3-5 year old children attending the first to the third year of kindergarten; free from any systemic conditions and generally healthy; parents sign informed consent; having at least 1 tooth with cavitated dentine carious lesion Exclusion Criteria: are uncooperative to accept oral examination or treatment; have a significant systematic disease or long-term medications; have abnormal dentition. Teeth having signs or symptoms of irreversible pulpitis and non-vitality will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A- immediately rinse mouth<br>Children are instructed to rinse their teeth with a cup of water containing about 50 ml immediately after SDF treatment. Afterwards, no post-treatment protocol is given to children. | Drug: 38% SDF treatment<br>* Children with active caries will receive 38% silver diamine fluoride treatment<br>Behavioral: rinse mouth immediately after SDF treatment<br>* After receiving 38% silver diamine fluoride treatment, Children will be asked to rinse their mouths immediately.<br>|
| Experimental: Group B- not to rinse for at least 30 minutes<br>Children are instructed not to eat and drink for at least 30 minutes. | Drug: 38% SDF treatment<br>* Children with active caries will receive 38% silver diamine fluoride treatment<br>Behavioral: not to rinse for at least 30 minutes after SDF treatment<br>* After receiving 38% silver diamine fluoride treatment, Children will be asked not to rinse their mouths for at least 30 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries status | The proportion of the soft (active) carious tooth lesion surfaces that harden (arrested) at 12 months of follow-up will be measured | at 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The visible plaque index (VPI) | Two areas (buccal and lingual) of each of the six index teeth (55/51/63/71/75/83) will be examined and recorded (presence/absence) the status of visible plaque. | at 12-month follow-up | 
| dmft index | The caries experience will be recorded to assess the caries increment by using dmft index at baseline and 12 months later | at 12-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dental caries, preschool children, silver diamine fluoride