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

Postoperative Pain After Application of Silver Diamine Fluoride Verses Sodium Fluoride Varnish in Treatment of Carious Primary Teeth (A Randomized Clinical Trial)

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries in Children
• Intervention / Treatment: Drug: Silver Diamine Fluoride; Drug: Sodium Fluoride varnish

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Pediatric Dentistry, Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Silver Diamine Fluoride; SDF will be applied with a brush.; Other Names: SDF
Active Comparator: 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.	Drug: Sodium Fluoride varnish; NaF will be applied with a brush; Other Names: NaF varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Eman S Elmasry, Professor, Pediatric Dentistry, Faculty of Dentistry, Cairo University; Study Director: Fatma KI Abdelgawad, Lecturer, Pediatric Dentistry, Faculty of Dentistry, Cairo University; Principal Investigator: Marwa A Salmoon, MSc, Pediatric Dentistry, Faculty of Dentistry, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: June 12, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: CEBD-CU-2018-06-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: outcome results for both groups will be shared
• IPD Sharing Time Frame: to be determined later
• IPD Sharing Access Criteria: to be determined later
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes