Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride

Caries; Initial Clinical Trial

Official title:

Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05094492
• Other study ID #: p11-4
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2021
• Source: Cairo University
• Contact: Omar O Shaalan, PhD
• Phone: 00201122665661
• Email: omar.shaalan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.

Description:

This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: June 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Active carious white spot lesions.

• Patient compliance.

• Controlled oral hygiene condition.

Exclusion Criteria:

• Participant in another trial.

• Non carious lesions.

• Systemic diseases or concomitant medication affecting salivary flow.

• Cavitation of carious lesions.

• Parafunctional habits.

• Pregnancy.

Related Conditions & MeSH terms

• Caries; Initial

Intervention

Combination Product:
• Curodont Repair Fluoride Plus
P11-4 self assembling peptide combined with fluoride

Other:
• Bifluorid 10 fluoride varnish
5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remineralization	measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion	6 months