Clinical trial NCT03557996: Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish
Official title: Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Caries in Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 42
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patient will receive either silver diamine fluoride or sodium fluoride varnish
Primary purpose: TREATMENT

Brief summary: To assess discoloration of carious primary teeth after application of silver diamine fluoride versus sodium fluoride varnish.

Detailed description: The American Academy of Pediatric Dentistry's (AAPD) guidelines (2017) stated that Silver diamine fluoride (SDF) is a brush-on liquid that arrest 87.7% of dental caries lesions. The success rate is similar for restorations placed under GA. One of the most exciting aspects of SDF is the 67±4% decrease in new lesions on untreated surfaces, achieved simply by treating active lesions .This is not the same as incidence of any new lesions (elaborated above for treatment under GA), however the relation warrants further investigation.

Benefit to the patient

* No pain and infection.
* Enhance child cooperation.
* Enhance better patient compliance.
* Decrease cost of dental treatment and may eliminate the need for General Anesthesia.

Benefit to the dentist

* Develop an effective fast easy method to arrest the caries by using SDF.
* Ease of dental treatment.
* Better cooperation with the child.
* The procedure is simple.
* Inexpensive and non-invasive.
* It does not require expensive equipment or support infrastructure, such as pipe water or electricity.

Benefit to the population

* Reduce the harmful impact of oral health problems in preschool children from low income families.
* SDF can be considered a user-friendly material for use in dental clinics as well as remote areas, schools or deprived communities.

Children aged 2-5 years can benefit from the use of SDF, an easy anticaries treatment. Furthermore, children in this age group may benefit from delayed dental treatment and overall caries arrest, thus reducing potential pain and infection, expensive future emergency room visits, the need for general anesthesia or traumatic dental experiences on uncooperative children.

Eligibility criteria: Inclusion Criteria:

1. Children with carious primary teeth before eruption of permanent teeth
2. High caries risk patients with anterior or posterior carious lesions
3. Uncooperative children without access to or with difficulty accessing dental care.

Exclusion Criteria:

1. Children with spontaneous or elicited pain from caries
2. Tooth mobility
3. Signs of pulpal infection
4. Severe medical conditions that would not allow management in the clinic

Primary outcomes:
measure: Discoloration
timeFrame: 12 months
Secondary outcomes:
measure: Investigator reported discoloration
timeFrame: 12 months
measure: Timing of discoloration
timeFrame: 12 months
measure: Caries arrest (dentine texture)
timeFrame: 12 months
measure: Postoperative Pain: Questioning the patient
timeFrame: 12 months
measure: Parental satisfaction: Questioning the parent
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Dentistry, Faculty of Dentistry, Cairo University
Study officials:
affiliation: Pediatric Dentistry,Faculty of Dentistry, Cairo University
name: Nevine G Waly, Professor
role: STUDY_DIRECTOR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Eman S Elmasry, Professor
role: STUDY_CHAIR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Fatma KI Abdelgawad, Lecturer
role: STUDY_DIRECTOR
affiliation: Pediatric Dentistry, Faculty of Dentistry, Cairo University
name: Yousra M Abdel Rehim, MSc
role: PRINCIPAL_INVESTIGATOR
References: