Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children

NCT06576960 | Completed DMC

• 1 other identifier: OH12-12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (4)

• Salivary PH

  Salivary power of hydrogen at baseline, one month, 3months and six months after intervention

  6 months

• Salivary streptococcus mutants count

  Count of bacteria at baseline, one day, 3months and six months after intervention

  6months

• Lactobacillus count

  Count of bacteria at baseline, one day, 3months and six months after intervention

  6 months

• Immunoglobulin A

  Level of immunoglobulin A at saliva at baseline, one day, 3months and 6 months after intervention

  6months

Study Arms (3)

nano silver varnish

EXPERIMENTAL

new fluoride varnish

Drug: Nano silver fluoride varnish and tri calcium phosphate varnish

tri calcium phosphate varnish

EXPERIMENTAL

fluoride varnish contain calcium phosphate

Drug: Nano silver fluoride varnish and tri calcium phosphate varnish

health education

NO INTERVENTION

Interventions

Nano silver fluoride varnish and tri calcium phosphate varnish DRUG

Fluoride varnishes

Also known as: health education

nano silver varnish; tri calcium phosphate varnish

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Visually impaired children

You may not qualify if:

• uncooperative children or children not willing to participate in the study.
• Children with systemic diseases
• Children with bronchial asthma.
• Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months
• History of fluoride treatment in the past 3-4 weeks.

Sponsors & Collaborators

• Hadeer Mohammed Abd El wahab: lead
• Tanta University: collaborator

Study Sites (1)

Faculty of dentistry

Tanta, Tanta City, 31527, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hatem Amin, PhD

  Faculty of dentistry . Tanta university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: El Mahalla Elkobra

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 29, 2024
• Study Start: October 11, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 13, 2023
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)