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

NCT04929509 | Unknown

• 1 other identifier: P11-4 in white spot lesions
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• Change in the activity status of lesions scored using ICDAS-LAA

  Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up.

  12 months

Secondary Outcomes (2)

• Change in mean DIAGNOdent readings.

  12 months

• Microbial count of mutans streptococci, lactobacilli.

  6 months

Study Arms (3)

self-assembling peptide (P11-4)

EXPERIMENTAL

Curodont Repair; Credentis will be applied to the white spot lesion at baseline.

Other: self-assembling peptide

nanosilver fluoride varnish

ACTIVE COMPARATOR

(Study group) Nano-silver fluoride varnish will be applied to the white spot lesion at baseline.

Other: nanosilver fluoride varnish

sodium fluoride varnish

PLACEBO COMPARATOR

(Control group) Fluoride varnish (Duraflor) will be applied to the white spot lesion at baseline and 6 months follow up.

Other: sodium fluoride varnish

Interventions

self-assembling peptide OTHER

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

Also known as: Curodont repair

self-assembling peptide (P11-4)

nanosilver fluoride varnish OTHER

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.

nanosilver fluoride varnish

sodium fluoride varnish OTHER

5% sodium fluoride varnish; One ml of fluoride varnish contains 50 mg of sodium fluoride in an alcohol-based suspension of resins.

Also known as: duraflor

sodium fluoride varnish

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Faculty of dentistry

Alexandria, Egypt

RECRUITING

Related Publications (2)

• Atteya SM, Amer HA, Saleh SM, Safwat Y. The effect of nano silver fluoride, self-assembling peptide and sodium fluoride varnish on salivary cariogenic bacteria: a randomized controlled clinical trial. Clin Oral Investig. 2024 Feb 23;28(3):167. doi: 10.1007/s00784-024-05562-0.

  PMID: 38388987 DERIVED

• Atteya SM, Amer HA, Saleh SM, Safwat Y. Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: randomized controlled clinical trial. BMC Oral Health. 2023 Aug 19;23(1):577. doi: 10.1186/s12903-023-03269-4.

  PMID: 37598194 DERIVED

MeSH Terms

Interventions

Bifluorid 12; Duraflor

Study Officials

• Hala A Amer, PHD

  Alexandria University

  STUDY DIRECTOR

• Susan M Saleh, PHD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Yara S Selim, PHD

  Alexandria University

  PRINCIPAL INVESTIGATOR

• Sara M Atteya, PHD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 18, 2021
• Study Start: December 5, 2020
• Primary Completion: October 5, 2021
• Study Completion: January 1, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

EG (1)