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

NCT03554980 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: CEBD-CU-2018-06-1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Postoperative pain will be assessed through questioning the patient and/or parent .Binary (Yes or No)

  12 months

Secondary Outcomes (3)

• Parental satisfaction

  12 months

• Caries arrest (dentin texture) Cries arrest (Dentine texture)

  12 months

• Discoloration (yellow, brown, black)

  12 months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

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

Interventions

Silver Diamine Fluoride DRUG

SDF will be applied with a brush.

Also known as: SDF

Group 1

Sodium Fluoride varnish DRUG

NaF will be applied with a brush

Also known as: NaF varnish

Group 2

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children with spontaneous or elicited pain from caries
• Tooth mobility
• Signs of pulpal infection
• Severe medical conditions that would not allow management in the clinic
• Hereditary developmental defects, such as amelogenesis imperfecta or dentinogenesis imperfecta
• Known allergies or sensitivities to dental materials, including SDF
• Inability to return for recall visits
• Refusal of participation from the guardian or parents

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Pediatric Dentistry, Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

silver diamine fluoride; Bifluorid 12

Study Officials

• Nevine G Waly, Professor

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  STUDY CHAIR

• Eman S Elmasry, Professor

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Fatma KI Abdelgawad, Lecturer

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Marwa A Salmoon, MSc

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa A Salmoon, MSc

CONTACT

01016555055; dr.marwasalmon@gmail.com

Fatma KI Abdelgawad, Lecturer

CONTACT

01006753265; fatmadent@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (participant, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: patient will receive either Silver Diamine Fluoride or Sodium Fluoride varnish according to the allocation ratio

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: December 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: to be determined later
• Access Criteria: to be determined later

Locations

EG (1)