Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

October 14, 2022 updated by: Hams Hamed Abdelrahman

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I
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
Active Comparator: Group III
Other: 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
Experimental: Group II
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 3 months , 6 months, 9 months, 12 months
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
Baseline, 1 month, 3 months , 6 months, 9 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hams Hamed Abdelrahman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

October 14, 2022

First Submitted That Met QC Criteria

October 14, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • biomimetic scaffolds _2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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