Antibacterial Effect of Nano Silver Fluoride vs Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique

NCT03186261 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: amshamaa
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

• The teeth of the patients that meet inclusion criteria will be anesthetized, isolated with a rubber dam.
• Cavity opened using conventional high-speed rotary instruments.
• The central cariogenic biomass and the superficial parts of the necrotic dentine will be removed with round burs.
• Caries lesion will be completely removed in the enamel/dentin junction.
• The excavation procedure will be terminated as soon as the soft and wet dentine was removed and the remaining tissue was leathery but not hard on exploring.
• A dentinal sample will then be collected from the base of the cavity using sterile spoon excavator as a baseline for bacteriological assessment.
• Then, application of either intervention or control agent, another dentinal sample will be collected using a sterile excavator and transferred into sterile tubes and transferred to the laboratory for microbiological analysis.
• Filling of the cavity with resin composite restoration.
• All clinical procedures will be carried out at the same visit.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• Bacterial Count of Streptococus Mutans

  Digital Colony Counter, Agar Diffusion test

  5 minutes on average between baseline and after application of the solution

Study Arms (2)

Nano silver fluoride solution

EXPERIMENTAL

Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.

Drug: Nano silver fluoride solution

Cavity Cleanser

ACTIVE COMPARATOR

Chlorhexidine digluconate 2 % solution (Cavity Cleanser, Bisco, USA). Each tooth will receive two drops of cavity cleanser with a micro brush, equivalent to a dose of 10 mg of the solution.

Drug: Cavity Cleanser

Interventions

Nano silver fluoride solution DRUG

Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties.

Also known as: NSF

Nano silver fluoride solution

Cavity Cleanser DRUG

Moistens dentin surface after cavity preparation using a micro brush.

Also known as: Chlorhexidine digluconate 2 % solution

Cavity Cleanser

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Not received antibiotic therapy since 1 month before sampling.
• Good oral hygiene.
• Co-operative patients approving the trial.
• Class I deep caries lesions in permanent molar (reaching ≥ 1/2 of the dentin on radiographic examination).
• Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).

You may not qualify if:

• Pregnancy.
• Systemic disease or severe medical complications.
• Heavy smoking.
• Xerostomia.
• Lack of compliance.
• Class II caries lesion.
• Shallow or enamel caries.
• Cuspal loss or caries beneath the gingival margin.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University.

Cairo, 11311, Egypt

Location

Related Publications (1)

• Mohan PV, Uloopi KS, Vinay C, Rao RC. In vivo comparison of cavity disinfection efficacy with APF gel, Propolis, Diode Laser, and 2% chlorhexidine in primary teeth. Contemp Clin Dent. 2016 Jan-Mar;7(1):45-50. doi: 10.4103/0976-237X.177110.

  PMID: 27041900 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Bisco Cavity Cleanser; chlorhexidine gluconate; Solutions

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Results Point of Contact

• Title: Ali Mostafa Shamaa
• Organization: Faculty of Dentistry, Cairo University

alishamaa@hotmail.com

+201005276468

Study Officials

• Randa Hafez, PHD

  Cairo University

  STUDY DIRECTOR

• Mai Mamdouh, PHD

  Cairo University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Dentist at Suez health directorate

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 14, 2017
• Study Start: April 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 28, 2018
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)