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

NCT03557996 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: CEBD-CU-2018-06-2
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• Discoloration

  Discoloration will be assessed by questioning the patient and/or the guardian.binary (yes or no)

  12 months

Secondary Outcomes (5)

• Investigator reported discoloration

  12 months

• Timing of discoloration

  12 months

• Caries arrest (dentine texture)

  12 months

• Postoperative Pain: Questioning the patient

  12 months

• Parental satisfaction: Questioning the parent

  12 months

Study Arms (2)

Group 1

EXPERIMENTAL

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

Drug: Silver Diamine Fluoride

Group 2

ACTIVE COMPARATOR

5% Sodium fluoride varnish will be applied four times annually and patient 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

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 DIRECTOR

• Eman S Elmasry, Professor

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  STUDY CHAIR

• Fatma KI Abdelgawad, Lecturer

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  STUDY DIRECTOR

• Yousra M Abdel Rehim, MSc

  Pediatric Dentistry, Faculty of Dentistry, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousra M Abdel Rehim, MSc

CONTACT

01273335144; yousra.mohamed@dentistry.cu.edu.eg

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-outcome 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

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: December 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 18, 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)