NCT05584878

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

October 14, 2022

Last Update Submit

October 14, 2022

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (2)

  • 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

  • change in ICDAS scores

    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

    Baseline, 1 month, 3 months , 6 months, 9 months, 12 months

Study Arms (3)

Group I

EXPERIMENTAL
Other: Curodont repair Self- assembling peptide P11-4

Group II

EXPERIMENTAL
Other: Ph-chi phosphorylated - nano-chitosan

Group III

ACTIVE COMPARATOR
Other: CCP-ACP " +ve control " Casein phosphopeptide amorphous calcium phosphate

Interventions

Curodont repair Self- assembling peptide P11-4OTHER

The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by Curodont

Group I
Ph-chi phosphorylated - nano-chitosanOTHER

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

Group II
CCP-ACP " +ve control " Casein phosphopeptide amorphous calcium phosphateOTHER

The labial surface of each tooth in both arches from central to the first premolar on both sides will be treated by CCP-ACP

Group III

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Related Publications (1)

  • Soliman EM, Abdelfattah WM, Mohamed DR, Nagui DA, Holiel AA. Clinical evaluation of the remineralizing potential of biomimetic scaffolds on enamel white spot lesions: A 12-month randomized controlled trial. J Dent. 2025 Dec 16;166:106303. doi: 10.1016/j.jdent.2025.106303. Online ahead of print.

    PMID: 41412271DERIVED

Central Study Contacts

Eman M Elsayed, Msc

CONTACT

01224056863dr.e_jersy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of DPH and Clinical statistician

Study Record Dates

First Submitted

October 14, 2022

First Posted

October 18, 2022

Study Start

January 1, 2023

Primary Completion

January 30, 2024

Study Completion

January 30, 2024

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

EG(1)