NCT04401280

Brief Summary

the aim of this study is to evaluate the effectiveness of BiominF® and Novamin® in comparison to Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in the treatment of enamel white spot lesions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

May 15, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 19, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

May 15, 2020

Last Update Submit

October 11, 2021

Conditions

White Spot Lesion of Tooth

Keywords

Bioactive glassCPP-ACPRemineralizationWhite spot lesions

Outcome Measures

Primary Outcomes (1)

  • Change in White spot lesions dimension

    Quantified using computer-assisted analysis based on digital intraoral photographs

    6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)

Secondary Outcomes (1)

  • change in lesion fluorescence

    6 months: (Baseline, 1 week, 1 month, 3 months, 6 months)

Study Arms (3)

BiominF®

ACTIVE COMPARATOR

Test group

Drug: BiominF

Novamin®

ACTIVE COMPARATOR

Test group

Drug: Novamin

CPP-ACP

ACTIVE COMPARATOR

Control group

Drug: CPP-ACP

Interventions

BiominFDRUG

in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached

BiominF®
NovaminDRUG

in office application of bioactive glass followed by self administered application by the patient until a point of white spot remineralization is reached

Novamin®
CPP-ACPDRUG

applied in accordance with the manufacturer's specifications

CPP-ACP

Eligibility Criteria

Age14 Years - 26 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Not less than 1 white spot lesion on the labial surface of teeth in the anterior region with code 2 International Caries Detection and Assessment System II (ICDAS-II) or less
  • Absence of any active periodontal disease.
  • Written informed consent

You may not qualify if:

  • Known hypersensitivity/allergy to study products and/or materials used
  • teeth having deep carious lesions or extensive restorations
  • Unwillingness to be randomly assigned to 1 of the 3 treatment groups
  • Advanced periodontal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Alexandria, Egypt

Location

MeSH Terms

Interventions

NovaMincasein phosphopeptide-amorphous calcium phosphate nanocomplex

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical instructor and Principal investigator at conservative dentistry department

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 26, 2020

Study Start

June 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 19, 2021

Record last verified: 2021-10

Locations

EG(1)