Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

White Spot Lesion Clinical Trial

Official title:

Clinical and Topographic Evaluation of the Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions (a Randomized Controlled Clinical Trial and In-vitro Study)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05584878
• Other study ID #: biomimetic scaffolds _2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: October 2022
• Source: Alexandria University
• Contact: Eman M Elsayed, Msc
• Phone: 01224056863
• Email: dr.e_jersy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The modern concept in caries treatment focuses on the non-invasive approach and on the biomimetic remineralization of early non-cavitated white spot carious lesions. Recently developed biomimetic scaffolds attempt to remineralize the dental tissues and are more regenerative than reparative.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Patients who at least have 1 white spot lesion.
• No systemic diseases or taking any medication affecting salivary flow.
• Patients with good oral hygiene measures.
• Patients with moderate caries risk assessment.
• Post orthodontic WSLs with International Caries Detection and Assessment System (ICDAS II) scoring criteria (1-2).

Exclusion Criteria:

• Participant in another trial.
• Developmental non carious lesion (enamel hypoplasia and dental fluorosis).
• Presence of abnormal oral disease, or medically compromised patients.
• Participants who had evidence of reduced salivary flow or significant tooth wear.
• Allergy to milk products or other drug allergies.

Related Conditions & MeSH terms

• White Spot Lesion

Intervention

Other:
• Curodont repair Self- assembling peptide P11-4
The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by Curodont
• Ph-chi phosphorylated - nano-chitosan
The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by Ph-chi phosphorylated - nano-chitosan
• CCP-ACP " +ve control " Casein phosphopeptide amorphous calcium phosphate
The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by CCP-ACP

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DIAGNOdent values	The DIAGNOdent uses laser fluorescence to aid in the detection of caries within the tooth structure.	Baseline, 1 month, 3 months , 6 months, 9 months, 12 months
Primary	change in ICDAS scores	Code Description 0: Sound tooth surface: No evidence of caries after 5 sec air drying; First visual change in enamel: Opacity or discoloration (white or brown) is visible at the entrance to the pit or fissure seen after prolonged air drying; Distinct visual change in enamel visible when wet, lesion must be visible when dry; Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying; Underlying dark shadow from dentine; Distinct cavity with visible dentine; Extensive (more than half the surface) distinct cavity with visible dentine	Baseline, 1 month, 3 months , 6 months, 9 months, 12 months