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Cariostatic and Remineralizing Effects of Three Different Dental Varnishes

Primary Purpose

Dental Caries in Children, Cariostatic Agent, Resistance, Dental Caries

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nano Silver Fluoride varnish
nano-hydroxyapatite varnish
sodium Fluoride Varnish
Sponsored by
Nisreen Ibrahim khan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring Dental caries prevention, NSF (nano silver fluoride), n-HAP (Nano hydroxyapatite ), NaF ( Sodium Fluoride), ICDAS II, Enamel biopsy

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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:

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

Sites / Locations

  • Faculty of Dentistry / Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group of • Nano Silver Fluoride varnish ( NSF)

group of Nano hydroxyapatite varnish (n-HAP)

group of Sodium Fluoride Varnish (NaF)

Arm Description

Selected children will be divided randomly into three groups: Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =50).

Group 2 Children receiving Nano-hydroxyapatite varnish (n = 50)

Group 3: Children receiving Sodium Fluoride Varnish (n = 50)

Outcomes

Primary Outcome Measures

a. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria
After taking the personal data of the participant, dental examination will be conducted by one trained and calibrated examiner under the standard situation including semi-supine position of the subject, good illumination and taking into account all methods of infection control. Baseline dental examination for all surfaces of included teeth according to ICDAS II was recorded. Only the surfaces with 0, 1 and 2 score will be included in the follow up assessment (Drying of the tooth surface is the key for detecting non-cavitated lesions). Diagnostic criteria for newly dental caries : In order to compare the preventive efficacy of the three preventive agent, any change in the baseline recording of score 0, 1, or 2 will be recorded in each visit of all three groups, and an comparison will be made between the mean of tooth surfaces with score 0, 1 or 2 in the baseline visit and during all follow-up visits in each group and after that comparing among all groups.
Enamel biopsy for detecting Calcium and Fluoride content .
The tooth on which the biopsy had to be done will be isolated with the help of cotton rolls and high volume suction to eliminate any chances of saliva contamination. Sticking plaster will be used to cover the tooth to be subjected for biopsy. A 6 mm circular punch will be made in the sticking plaster keeping in mind that it should be present on the buccal surface of molar. A 6 mm non-fluoride containing circular blotting paper will wetted with 5 µL of 30% phosphoric acid and immediately placed on the punched window for 4 s . This filter paper will then transferred to plastic tube which had 0.1 ml of double distilled water pipetted using a micro-pipette. Equal amount of total ionic strength adjustment buffer (TISAB-II) will added using a micropipette to the plastic tube, after which it will be stored for 3 days. After that it will send to laboratory for fluoride and calcium analysis.At the end -fluoride varnish will be applied to the surface.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2021
Last Updated
June 4, 2022
Sponsor
Nisreen Ibrahim khan
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1. Study Identification

Unique Protocol Identification Number
NCT04887389
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nisreen Ibrahim khan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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: Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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 .
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group of • Nano Silver Fluoride varnish ( NSF)
Arm Type
Experimental
Arm Description
Selected children will be divided randomly into three groups: Group 1: Children receiving Nano Silver Fluoride varnish (NSF) (n =50).
Arm Title
group of Nano hydroxyapatite varnish (n-HAP)
Arm Type
Experimental
Arm Description
Group 2 Children receiving Nano-hydroxyapatite varnish (n = 50)
Arm Title
group of Sodium Fluoride Varnish (NaF)
Arm Type
Experimental
Arm Description
Group 3: Children receiving Sodium Fluoride Varnish (n = 50)
Intervention Type
Drug
Intervention Name(s)
Nano Silver Fluoride varnish
Other Intervention Name(s)
( NSF)
Intervention Description
Nano Silver Fluoride(5%) is a new experimental formulation containing silver nanoparticles, chitosan and fluoride combines preventive and antimicrobial properties. It is a yellow solution and safe to be used in humans
Intervention Type
Drug
Intervention Name(s)
nano-hydroxyapatite varnish
Other Intervention Name(s)
(n-HAP)
Intervention Description
nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.
Intervention Type
Drug
Intervention Name(s)
sodium Fluoride Varnish
Other Intervention Name(s)
NaF
Intervention Description
Fluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents
Primary Outcome Measure Information:
Title
a. Clinical evaluation using international caries detection and assessment system (ICDAS II visual scoring criteria
Description
After taking the personal data of the participant, dental examination will be conducted by one trained and calibrated examiner under the standard situation including semi-supine position of the subject, good illumination and taking into account all methods of infection control. Baseline dental examination for all surfaces of included teeth according to ICDAS II was recorded. Only the surfaces with 0, 1 and 2 score will be included in the follow up assessment (Drying of the tooth surface is the key for detecting non-cavitated lesions). Diagnostic criteria for newly dental caries : In order to compare the preventive efficacy of the three preventive agent, any change in the baseline recording of score 0, 1, or 2 will be recorded in each visit of all three groups, and an comparison will be made between the mean of tooth surfaces with score 0, 1 or 2 in the baseline visit and during all follow-up visits in each group and after that comparing among all groups.
Time Frame
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
Title
Enamel biopsy for detecting Calcium and Fluoride content .
Description
The tooth on which the biopsy had to be done will be isolated with the help of cotton rolls and high volume suction to eliminate any chances of saliva contamination. Sticking plaster will be used to cover the tooth to be subjected for biopsy. A 6 mm circular punch will be made in the sticking plaster keeping in mind that it should be present on the buccal surface of molar. A 6 mm non-fluoride containing circular blotting paper will wetted with 5 µL of 30% phosphoric acid and immediately placed on the punched window for 4 s . This filter paper will then transferred to plastic tube which had 0.1 ml of double distilled water pipetted using a micro-pipette. Equal amount of total ionic strength adjustment buffer (TISAB-II) will added using a micropipette to the plastic tube, after which it will be stored for 3 days. After that it will send to laboratory for fluoride and calcium analysis.At the end -fluoride varnish will be applied to the surface.
Time Frame
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"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The inclusion criteria of participated children : Age rang 7-10 years. Teeth with score 0, 1 or 2 according to (international caries detection and assessment system) ICDAS II index. Patient did not receive any re-mineralizing agent other than the regular toothpaste during the past three months. No known history of allergy against silver particles or colophonium. written informed consent from the parents/guardians. Exclusion Criteria: Teeth with score 3 or more according to ICDAS II index. Partially erupted permanent teeth.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salwa A Hegazy, PhD
Organizational Affiliation
Head of Dental Public Health department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry / Mansoura University
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30854195
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.
Results Reference
result
PubMed Identifier
18491761
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.
Results Reference
result
PubMed Identifier
20129891
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.
Results Reference
result
PubMed Identifier
19498220
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.
Results Reference
result
PubMed Identifier
25506416
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.
Results Reference
result
PubMed Identifier
24818873
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.
Results Reference
result

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Cariostatic and Remineralizing Effects of Three Different Dental Varnishes

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