Clinical trial NCT03063307: Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
Official title: Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: Tooth, Deciduous
Dental Caries
Glass Ionomer Cements
Dental Atraumatic Restorative Treatment
Cariostatic Agents
Fluorides
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State University
First posted: 2017-02-24
Enrollment: 119
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment.

Detailed description: The present controlled clinical randomized study aiming at evaluating the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain or pulp involvement. The participants will be allocated randomly to one of two treatment groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In both groups, the guardians and children will receive oral hygiene instructions and will be advised about eating habits and fluoride dentifrice use.The clinical success will be verified through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical evaluations to detect caries arresting, representing the primary outcome of the study.

Eligibility criteria: Inclusion Criteria:

* CHILDREN

  * aged 2 to 5 years;
  * who are in good general health;
  * have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS codes 5 or 6.

Exclusion Criteria:

* CHILDREN

  * with systemic or neurological diseases;
  * whose families intend to move from Rio de Janeiro next year;
  * with a history of allergy to silver or any substance present in the different materials to be used for treatment.

TEETH

* with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement;
* shows possible pulp involvement by radiographic examination

Primary outcomes:
measure: Caries arresting
timeFrame: The follow-up oral examinations will be conducted every 3 months for 48 months totally
Secondary outcomes:
measure: Duration of the intervention visit
timeFrame: 1 year
measure: Cost
timeFrame: 1 year
measure: Aesthetic perception and treatment satisfaction
timeFrame: First appointment, 3,6 and 12 months after treatment.
measure: Anxiety
timeFrame: From allocation up to two weeks.
measure: Quality of life assessment
timeFrame: First appointment,15 days and 3 months after treatment.
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Departamento de Odontopediatria e Ortodontia da UFRJ
Study officials:
affiliation: Universidade Federal Fluminense
name: Ana Lucia Vollu, MSD Student
role: PRINCIPAL_INVESTIGATOR
References: