Application of SDF Verses NaF Varnish in Treatment of Carious Primary Teeth

NCT ID: NCT03554980

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-06-01

Brief Summary

The aim of this study is to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.

Detailed Description

Untreated dental decay and poor access to dental care are significant Public health problems for children in the world (Dye et al. 2015 and Horst, 2016). Early childhood caries is a multifactorial, infectious and transmissible dental disease affecting young children . Conventional restorative treatment may fail to reduce the burden of early childhood caries in many parts of the world. Most decayed teeth in preschool children remained unrestored . Consequences of untreated decay in preschool children may include increased risk of future caries in primary and permanent dentition, pain and infections; increased expensive emergency room visits and hospital admissions; increased treatment costs because of extensive decay and the accompanying need for general anesthesia; delayed growth and development; and missed days from school and work .To reduce the burden of caries disease in young children and to avoid possible serious consequences of untreated decay, it is important to identify an effective, low-cost method of treating caries in children at high risk of caries and with limited access to dental care. Silver diamine fluoride (SDF) has been identified as an anticariogenic agent that successfully arrests dental decay and has the potential to address the epidemic of untreated decay in young children

Therefore this study will be conducted to assess the postoperative pain after application of silver diamine fluoride versus sodium fluoride varnish in treatment of carious primary teeth.

Benefits of the research to the patient:

According to American Academy of Pediatric Dentistry (AAPD), 2017 SDF application is:

• Safe.
• Noninvasive.
• Inexpensive.
• Effective in dental caries management, especially arresting cavitated caries lesions in the primary dentition.

Benefits of the research to the clinician:

According to AAPD, 2017 SDF is:

• Easily performed.
• A promising strategy to manage dental caries in very young children or those who have special needs.
• Doesn't require cooperation from children during dental treatment.

It will improve patient confidence with the dentist

Explanation for choice of comparators:

The use of sodium fluoride is well documented in the literature as successful caries arrestment material. Arrestment proportion of caries for sodium fluoride varnish was found to be 84.4% (NaF) and 85.3% for ( NaF + chlorohexidine mouth wash) .

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

38% silver diamine fluoride liquid will be applied twice annually and patients will be followed up at 0,1,3,6, 9 and 12.

SDF is a 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 patients 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

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

SDF; NaF varnish

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

5. Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta

6. Known allergies or sensitivities to dental materials, including SDF

7. Inability to return for recall visits

8. Refusal of participation from the guardian or parents

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa A Salmoon, MSc

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevine G Waly, Professor

Role: STUDY_CHAIR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Eman S Elmasry, Professor

Role: STUDY_DIRECTOR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Fatma KI Abdelgawad, Lecturer

Role: STUDY_DIRECTOR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Marwa A Salmoon, MSc

Role: PRINCIPAL_INVESTIGATOR

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Locations

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Marwa A Salmoon, MSc

Role: CONTACT

dr.marwasalmon@gmail.com

01016555055

Fatma KI Abdelgawad, Lecturer

Role: CONTACT

fatmadent@hotmail.com

01006753265

Other Identifiers

CEBD-CU-2018-06-1

Identifier Type: -

Identifier Source: org_study_id