Comparing Two Brands of Silver Diamine Fluoride for Stopping Cavities in Children

N/AActive Not RecruitingNCT07708883

National Research Centre, Egypt134 enrolled

Overview

this study aims to evaluate two different materials used to stop dental caries in children. both materials are available at the market. both materials leave black stain after application. we follow up the patients for 1 year to evaluate which one is more effective in stopping dental caries.

Before application of SDF, to protect the surrounding gingival tissues, cotton rolls will be used to minimize potential pigmentation. The lips and surrounded skin will also be protected using Vaseline. SDF in both groups will be applied directly to the affected tooth surface only, excess SDF will be removed with gauze, and finally the site will be isolated for up to three minutes. All children will be recalled after 6 and 12 months for follow up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

134

Conditions

Dental Caries

Interventions

SDF, ToothMate®, EgyptOTHER

38% silver diamine fluoride manufactured in Egypt

SDF, Advantage Arrest USAOTHER

38% silver diamine fluoride , manufactured in USA

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Children who are apparently healthy with primary carious teeth aged from 4-7 years. * Uncooperative children. * Children with financial barrier in accessing dental care * Clinically: absence of any pathology or pain except of sensitivity with eating. * Parents and patients accepting the new treatment modality and parents assigned the informed consent. Exclusion Criteria: * Known sensitivity to silver or other heavy-metal ions. * Children who will not comply to recall program. * Teeth with pulp involvement. * Tooth mobility (more than grade 1 (grade 1:1-2 mm tooth mobility). * History of pain for a long period of time that may indicate chronic pulp inflammation.

Locations (1)

National Research Centre

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

number of tooth with arrested caries in each group

Arrest of caries through: * tactile examination to assess hardness of treated lesions using gentle pressure with a probe, * color examination (yellow, brown or black)

Time frame: 12 months

Data from ClinicalTrials.gov

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