Remineralizing Potential of Biomimetic Scaffolds on Enamel White Spot Lesions

Sponsor
Hams Hamed Abdelrahman (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05584878
Collaborator
(none)
63
1
3
12.9
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Curodont repair Self- assembling peptide P11-4
  • Other: Ph-chi phosphorylated - nano-chitosan
  • Other: CCP-ACP " +ve control " Casein phosphopeptide amorphous calcium phosphate
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

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

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

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 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 Distinct visual change in enamel visible when wet, lesion must be visible when dry Localized enamel breakdown (without clinical visual signs of dentinal involvement) seen when wet and after prolonged drying Underlying dark shadow from dentine Distinct cavity with visible dentine Extensive (more than half the surface) distinct cavity with visible dentine

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts 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

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alexandria Faculty of Dentistry Alexandria Egypt

Sponsors and Collaborators

  • Hams Hamed Abdelrahman

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hams Hamed Abdelrahman, Assistant lecturer of DPH and Clinical statistician, Alexandria University
ClinicalTrials.gov Identifier:
NCT05584878
Other Study ID Numbers:
  • biomimetic scaffolds _2022
First Posted:
Oct 18, 2022
Last Update Posted:
Oct 18, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2022