P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions

June 15, 2021 updated by: Hams Hamed Abdelrahman

Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial)

Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy using Self-Assembling Peptide P11-4 (Curodont Repair) which enhances remineralization of white spot lesions. Purpose of the Study: The aim of this study is to compare clinically and microbiologically the therapeutic effect of Self Assembling Peptide P11-4 (Curodont Repair), nano silver fluoride varnish and 5% fluoride varnish (Duraflor) on remineralization of enamel White Spot Lesions in permanent teeth of adults.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. Sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: one application of Curodont Repair, study group 2: one application of Nano-silver fluoride varnish and Control group twice application of Fluoride Varnish (Duraflor).

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of Dentistry
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHO was selected (WHO, 2019). 2. The presence of at least one visible WSL in the buccal surface of permanent teeth with ICDAS II score of 1, or 2. 3. Completion of an informed consent to participate in the study

Exclusion Criteria:

  • 1. Patients receiving the following medications: tetracyclines, any other medication known to stain teeth or any medication causing dry mouth and/or limiting salivary flow. 2. Patients receiving any antibiotic within 1 month prior to each saliva sample collection 3. Selected tooth with microcavities or dentinal involvement due to loss of enamel tissues. 4. Selected tooth with a restoration adjacent to the lesions to avoid false- positive readings. 5. Selected tooth with fluoride application < 3 months prior to study treatment. 6. Selected tooth with discolouration, enamel hypoplasia or fluorosis. 7. Patients with multiple cavitations to avoid variability in microbiological analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: self-assembling peptide (P11-4)

Curodont Repair; Credentis will be applied to the

white spot lesion at baseline.
Other: self-assembling peptide
each Curodont Repair applicator unit contains both Curolox technology for guided enamel regeneration and water for activation of the device, each box contains 10 applicators
Other Names:
  • Curodont repair
Active Comparator: nanosilver fluoride varnish

(Study group) Nano-silver fluoride varnish will be applied to the

white spot lesion at baseline.
Other: nanosilver fluoride varnish
The synthesis of aqueous solution of silver nanoparticles will be carried out via the chemical reduction of silver nitrate (1 mL, 0.11 M) with sodium borohydride (0.3 mL, 0.8 M) and chitosan biopolymer (28.7 mL, 2.5 mg/mL) as a stabilizing agent. Sodium fluoride (10,147 ppm of fluorine) will be incorporated at the end of the experiment.
Placebo Comparator: sodium fluoride varnish

(Control group) Fluoride varnish (Duraflor) will be applied to the

white spot lesion at baseline and 6 months follow up.
Other: sodium fluoride varnish
5% sodium fluoride varnish; One ml of fluoride varnish contains 50 mg of sodium fluoride in an alcohol-based suspension of resins.
Other Names:
  • duraflor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the activity status of lesions scored using ICDAS-LAA
Time Frame: 12 months
Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean DIAGNOdent readings.
Time Frame: 12 months
Change in mean DIAGNOdent readings from baseline to each follow up period
12 months
Microbial count of mutans streptococci, lactobacilli.
Time Frame: 6 months
Microbial count of mutans streptococci, lactobacilli.from baseline to each follow up period
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Investigators

  • Study Director: Hala A Amer, PHD, Alexandria University
  • Principal Investigator: Susan M Saleh, PHD, Alexandria University
  • Principal Investigator: Yara S Selim, PHD, Alexandria University
  • Principal Investigator: Sara M Atteya, PHD, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2020

Primary Completion (Anticipated)

October 5, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P11-4 in white spot lesions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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