---
title: Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions
nct_id: NCT05584878
overall_status: UNKNOWN
phase: NA
sponsor: Hams Hamed Abdelrahman
study_type: INTERVENTIONAL
primary_condition: White Spot Lesion
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05584878.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05584878"
ct_last_update_post_date: 2022-10-18
last_seen_at: "2026-05-12T06:45:53.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

**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)

**NCT ID:** [NCT05584878](https://clinicaltrials.gov/study/NCT05584878)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 63
- **Lead Sponsor:** Hams Hamed Abdelrahman
- **Conditions:** White Spot Lesion
- **Start Date:** 2023-01-01
- **Completion Date:** 2024-01-30
- **CT.gov Last Update:** 2022-10-18

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 35 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Group I** (EXPERIMENTAL)
- **Group II** (EXPERIMENTAL)
- **Group III** (ACTIVE_COMPARATOR)

## Interventions

- **Curodont repair Self- assembling peptide P11-4** (OTHER) — 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** (OTHER) — 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** (OTHER) — The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by CCP-ACP

## Primary Outcomes

- **Change in DIAGNOdent values** _(time frame: 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.
- **change in ICDAS scores** _(time frame: 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

## Locations (1)

- Alexandria Faculty of Dentistry, Alexandria, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.alexandria faculty of dentistry|alexandria||egypt` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05584878.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05584878*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*