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

Phase 4

• Conditions: Dental Caries in Children
• Interventions: Drug: Silver Diamine Fluoride; Drug: Sodium Fluoride varnish

• Registration Number: NCT03554980
• Lead Sponsor: Cairo University

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) .

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-01
• Last Update Submitted: 2018-06-12
• Study First Posted: 2018-06-13
• Last Update Posted: 2018-06-14
• Study Start: 2018-12-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Silver Diamine Fluoride	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 2	Sodium Fluoride varnish	5% sodium fluoride varnish will be applied four times annually and patients will be followed up at 0,1,3,6,9 and 12.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	12 months	Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)

Secondary Outcome Measures

Name	Time	Method
Discoloration (yellow, brown, black)	12 months	Discoloration will be assessed through visual examination. Categorical
Parental satisfaction	12 months	Parental satisfaction will be assessed through questioning the parent. Binary (yes or no)
Caries arrest (dentin texture) Cries arrest (Dentine texture)	12 months	Caries arrest will be assessed through tactile examination (hard or soft). Categorical

Trial Locations

Locations (1)

Pediatric Dentistry, Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt