Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

Not Applicable

Not yet recruiting

• Conditions: White Spot Lesion
• Interventions: Other: CCP-ACP " +ve control " Casein phosphopeptide amorphous calcium phosphate; Other: Curodont repair Self- assembling peptide P11-4; Other: Ph-chi phosphorylated - nano-chitosan

• Registration Number: NCT05584878
• Lead Sponsor: Hams Hamed Abdelrahman

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Last Update Submitted: 2022-10-14
• Study First Posted: 2022-10-18
• Last Update Posted: 2022-10-18
• Study Start: 2023-01-01
• Primary Completion: 2024-01-30
• Study Completion: 2024-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III	CCP-ACP " +ve control " Casein phosphopeptide amorphous calcium phosphate	-
Group I	Curodont repair Self- assembling peptide P11-4	-
Group II	Ph-chi phosphorylated - nano-chitosan	-

Primary Outcome Measures

Name	Time	Method
change in ICDAS scores	Baseline, 1 month, 3 months , 6 months, 9 months, 12 months	Code 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
Change in DIAGNOdent values	Baseline, 1 month, 3 months , 6 months, 9 months, 12 months	The DIAGNOdent uses laser fluorescence to aid in the detection of caries within the tooth structure.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt