Clinical trial NCT04887389: Cariostatic and Remineralizing Effects of Three Different Dental Varnishes
Official title: Cariostatic and Remineralizing Effects of Three Different Dental Varnishes (A Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries in Children
Cariostatic Agent
Resistance, Dental Caries
Fluoride Varnishes
Keywords: Dental caries prevention
NSF (nano silver fluoride)
n-HAP (Nano hydroxyapatite )
NaF ( Sodium Fluoride)
ICDAS II
Enamel biopsy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 115
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Selected children will be divided randomly into three groups:

* Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =39).
* Group 2 Children receiving Nano-hydroxyapatite varnish (n = 37).
* Group 3: Children receiving Sodium Fluoride Varnish (n = 39) Procedure for material application The application of single drop (0.1 mL) of either (5%) NSF, (10%) n-HAP, (5%) NaF varnishes with a disposable micro-applicator tip for 10 seconds. NSF will be used in a single application and no repetition. While n-HAP, NaF varnishes will be applied each 6 months .
Primary purpose: PREVENTION

Brief summary: This study is a randomly, controlled, prospective in vivo study.

The objective of this study is:

To evaluate the cariostatic and re-mineralizing effects of Nano silver fluoride, Nano Hydroxyapatite and sodium fluoride varnishes in caries prevention through:

1. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria)
2. Calcium and fluoride content using enamel biopsy

Detailed description: Dental caries is a chronic, multi factorial, transmissible, infectious disease. Caries prevalence in young children in Egypt is very high, and most of the decayed teeth are left untreated, The increase prevalence of dental caries in children globally and in developing countries such as Egypt particularly makes the need for preventive treatment is necessary, one of the ways to prevent dental caries is the application of fluoride which can prevent dental caries by inhibiting demineralization of the crystal structures inside the tooth and enhancing remineralization.

Subsequently over the years various topical fluoride agents have been evolved but NaF (a 22,600 ppm F- preparation) is the most commonly used agent, Based on systematic studies, 5% NaF varnish was more effective in re-mineralizing early enamel caries.

Another anti caries product is a nano-hydroxyapatite (n-HAP), it has antibacterial effect, higher solubility, surface energy and bio activity, there are several studies concluded that 10% (n-HAP) may be optimal for remineralization of early enamel caries Nano-Silver Fluoride (NSF) is a new experimental formulation containing silver nanoparticles, it was introduced by Targino AG et al.(2014) to combat the problem of black discoloration of Silver Diamine Fluoride. It is safe to be used in humans and has effective antimicrobial properties against the pathogens responsible for the development of dental caries.

most of the studies have been evaluated the effectiveness of anti-caries agent in In Vitro and to the best of our knowledge, there are no published studies in Egypt on the effectiveness of these agent. As such, due to the continuous development of new remineralizing agents, research is needed to investigate the newer remineralizing agents under different circumstances. The present study will be carried out to evaluate the efficacy of Nano silver fluoride, Nano Hydroxyapatite and Sodium fluoride varnishes in caries prevention.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria of participated children :

  1. Age rang 7-10 years.
  2. Teeth with score 0, 1 or 2 according to (international caries detection and assessment system) ICDAS II index.
  3. Patient did not receive any re-mineralizing agent other than the regular toothpaste during the past three months.
  4. No known history of allergy against silver particles or colophonium.
  5. written informed consent from the parents/guardians.

     Exclusion Criteria:

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  1. Teeth with score 3 or more according to ICDAS II index.
  2. Partially erupted permanent teeth.

Primary outcomes:
measure: a. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria
timeFrame: 1. All children will be assessed clinically in four visits along one year, at the baseline as well as at 3rd, 6th and 12th month of follow up visit
measure: Enamel biopsy for detecting Calcium and Fluoride content .
timeFrame: Fluoride and calcium content will be evaluated at the baseline as well as at the last follow-up visit through study completion, an average of 1 year"
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry / Mansoura University
state: Dakahlia
Study officials:
affiliation: Head of Dental Public Health department
name: Salwa A Hegazy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abbass MMS, Mahmoud SA, El Moshy S, Rady D, AbuBakr N, Radwan IA, Ahmed A, Abdou A, Al Jawaldeh A. The prevalence of dental caries among Egyptian children and adolescences and its association with age, socioeconomic status, dietary habits and other risk factors. A cross-sectional study. F1000Res. 2019 Jan 3;8:8. doi: 10.12688/f1000research.17047.1. eCollection 2019.
citation: Azarpazhooh A, Main PA. Fluoride varnish in the prevention of dental caries in children and adolescents: a systematic review. Tex Dent J. 2008 Apr;125(4):318-37. No abstract available.
citation: Chu CH, Mei ML, Lo EC. Use of fluorides in dental caries management. Gen Dent. 2010 Jan-Feb;58(1):37-43; quiz 44-5, 79-80.
citation: Huang SB, Gao SS, Yu HY. Effect of nano-hydroxyapatite concentration on remineralization of initial enamel lesion in vitro. Biomed Mater. 2009 Jun;4(3):034104. doi: 10.1088/1748-6041/4/3/034104. Epub 2009 Jun 5.
citation: Pepla E, Besharat LK, Palaia G, Tenore G, Migliau G. Nano-hydroxyapatite and its applications in preventive, restorative and regenerative dentistry: a review of literature. Ann Stomatol (Roma). 2014 Nov 20;5(3):108-14. eCollection 2014 Jul.
citation: Targino AG, Flores MA, dos Santos Junior VE, de Godoy Bene Bezerra F, de Luna Freire H, Galembeck A, Rosenblatt A. An innovative approach to treating dental decay in children. A new anti-caries agent. J Mater Sci Mater Med. 2014 Aug;25(8):2041-7. doi: 10.1007/s10856-014-5221-5. Epub 2014 May 13.