NCT03930927

Brief Summary

During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2019

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

April 29, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

April 19, 2019

Last Update Submit

April 25, 2019

Conditions

White Spot Lesion of Tooth

Outcome Measures

Primary Outcomes (1)

  • Remineralizing process

    using DIAGNOpen.

    6 months

Secondary Outcomes (1)

  • Visual assessment

    6 months

Study Arms (2)

Self Assembling peptide

EXPERIMENTAL

intervention

Drug: Self Assembling peptideDrug: remineralizing agent

Fluoride

EXPERIMENTAL

Comparator

Drug: Self Assembling peptideDrug: remineralizing agent

Interventions

Self Assembling peptideDRUG

enamel regeneration

Also known as: Curodont
FluorideSelf Assembling peptide
remineralizing agentDRUG

enamel regeneration

Also known as: floride
FluorideSelf Assembling peptide

Eligibility Criteria

Age12 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with post orthodontic white spot lesion.
  • Patients with good oral hygiene.
  • Patients with good general health.
  • Cooperative patients.
  • Subjects who signed the informed consent.

You may not qualify if:

  • Patients with tetracycline pigmentation and dental fluorosis.
  • Enamel cavitation.
  • Disable patient.
  • patient with any systemic disease or severe medical complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

P11-4 peptide

Central Study Contacts

raneen ahmed gohar, Assistant lecturer

CONTACT

(002)01007331552raneen.aboelgheit@dentistry.cu.edu.eg

sherine hafez ibrahim, Assistant lecturer

CONTACT

(002)01099296591shereen.hafez@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

April 19, 2019

First Posted

April 29, 2019

Study Start

May 1, 2019

Primary Completion

October 1, 2020

Study Completion

March 1, 2021

Last Updated

April 29, 2019

Record last verified: 2019-04