Discoloration of Carious Primary Teeth After Application of Silver Diamine Fluoride Versus Sodium Fluoride Varnish

NCT ID: NCT03557996

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-06-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patient will receive either silver diamine fluoride or sodium fluoride varnish
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
double (participant-outcome assessor)

Study Groups

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Group 1

38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up as 0,1,3,6,9 and 12 SDF is brush on liquid

Group Type EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type DRUG

SDF will be applied with a brush

Group 2

5% Sodium fluoride varnish will be applied four times annually and patient will be followed up at 0,1,3,6,9 and 12

Group Type ACTIVE_COMPARATOR

Sodium Fluoride Varnish

Intervention Type DRUG

NaF will be applied with a brush

Interventions

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Silver Diamine Fluoride

SDF will be applied with a brush

Intervention Type DRUG

Sodium Fluoride Varnish

NaF will be applied with a brush

Intervention Type DRUG

Other Intervention Names

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SDF NaF varnish

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yousra Mohamed

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nevine G Waly, Professor

Role: STUDY_DIRECTOR

Pediatric Dentistry,Faculty of Dentistry, Cairo University

Eman S Elmasry, Professor

Role: STUDY_CHAIR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Fatma KI Abdelgawad, Lecturer

Role: STUDY_DIRECTOR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Yousra M Abdel Rehim, MSc

Role: PRINCIPAL_INVESTIGATOR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Locations

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Pediatric Dentistry, Faculty of Dentistry, Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Yousra M Abdel Rehim, MSc

Role: CONTACT

01273335144

Fatma KI Abdelgawad, Lecturer

Role: CONTACT

01006753265

Facility Contacts

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Fatma KI Abdelgawad, Lecturer

Role: primary

01006753265

Other Identifiers

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CEBD-CU-2018-06-2

Identifier Type: -

Identifier Source: org_study_id

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