Cariostatic and Remineralizing Effects of Three Different Dental Varnishes

NCT04887389 | Completed Phase 4 DMC

• 1 other identifier: A07071020
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

• 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.

  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"

Study Arms (3)

Group of • Nano Silver Fluoride varnish ( NSF)

EXPERIMENTAL

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

Drug: Nano Silver Fluoride varnish

group of Nano hydroxyapatite varnish (n-HAP)

EXPERIMENTAL

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

Drug: nano-hydroxyapatite varnish

group of Sodium Fluoride Varnish (NaF)

EXPERIMENTAL

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

Drug: sodium Fluoride Varnish

Interventions

Nano Silver Fluoride varnish DRUG

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

Also known as: ( NSF)

Group of • Nano Silver Fluoride varnish ( NSF)

nano-hydroxyapatite varnish DRUG

nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.

Also known as: (n-HAP)

group of Nano hydroxyapatite varnish (n-HAP)

sodium Fluoride Varnish DRUG

Fluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents

Also known as: NaF

group of Sodium Fluoride Varnish (NaF)

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• <!-- -->
• Teeth with score 3 or more according to ICDAS II index.
• Partially erupted permanent teeth.

Sponsors & Collaborators

• Nisreen Ibrahim khan: lead

Study Sites (1)

Faculty of Dentistry / Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (6)

• 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.

  PMID: 30854195 RESULT

• 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.

  PMID: 18491761 RESULT

• 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.

  PMID: 20129891 RESULT

• 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.

  PMID: 19498220 RESULT

• 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.

  PMID: 25506416 RESULT

• 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.

  PMID: 24818873 RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

N-Ethylmaleimide-Sensitive Proteins; Bifluorid 12

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

ATPases Associated with Diverse Cellular Activities; AAA Proteins; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Adenosine Triphosphatases; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Salwa A Hegazy, PhD

  Head of Dental Public Health department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Dental Public Health and Preventive Dentistry

Model Details: 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 .

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 14, 2021
• Study Start: August 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: February 1, 2023
• Last Updated: April 2, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)