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Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05584878
Enrollment
63
Registered
2022-10-18
Start date
2023-01-01
Completion date
2024-01-30
Last updated
2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

Brief 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.

Interventions

OTHERCurodont 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

OTHERPh-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

OTHERCCP-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

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in DIAGNOdent valuesBaseline, 1 month, 3 months , 6 months, 9 months, 12 monthsThe DIAGNOdent uses laser fluorescence to aid in the detection of caries within the tooth structure.
change in ICDAS scoresBaseline, 1 month, 3 months , 6 months, 9 months, 12 monthsCode Description 0: Sound tooth surface: No evidence of caries after 5 sec air drying 1. 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 2. Distinct visual change in enamel visible when wet, lesion must be visible when dry 3. Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying 4. Underlying dark shadow from dentine 5. Distinct cavity with visible dentine 6. Extensive (more than half the surface) distinct cavity with visible dentine

Countries

Egypt

Contacts

Primary ContactEman M Elsayed, Msc
dr.e_jersy@yahoo.com01224056863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026