Evaluation of State and Shade of White Spot Lesions After Using Different Remineralizing Agents (An in Vivo Study)

December 11, 2020 updated by: Hany Helmy Elsayed Mohammed, Al-Azhar University
The aim of the study is to evaluate the effect of Biomimetic remineralizing agent and resin modified glass ionomer varnish on color shade and state of white spot lesions immediately, after 3 months, and after 6 months. (An in vivo study).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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 Locations

  • Egypt
      • Cairo, Egypt, 11751
        • Al-Azhar University

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 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients included in this clinical trial were less than 30 years old.
  2. Patients with good general health.
  3. Patients who will agree to the consent and will commit to follow-up period.
  4. Fully erupted anterior teeth with no cavitated lesions.

Exclusion Criteria:

  1. Patients with any systemic disease that may affect normal healing.
  2. Patient with bad oral hygiene.
  3. Tetracycline or florosis staining.
  4. Patients who could/would not participate in all times of follow-up.
  5. Untreated periodontal disease was not allowed.
  6. Active caries or defective Restorations in 6 anterior teeth.
  7. Bleaching history
  8. Patients participating in more than 1 dental study.
  9. Patient received fluoride varnish before.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biomimetic remineralizing agent
Other: Biomimetic remineralizing agent
Self-assempling peptide
Other: Resin Modified Glass Ionomer Varnish
Resin Modified Glass Ionomer Varnish
ACTIVE_COMPARATOR: Resin modified glass ionomer varnish
Other: Biomimetic remineralizing agent
Self-assempling peptide
Other: Resin Modified Glass Ionomer Varnish
Resin Modified Glass Ionomer Varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
state of lesions
Time Frame: 6 months.
Digital scores
6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shade of lesions
Time Frame: 6 months
Digital scores
6 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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 (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 11, 2020

First Posted (ACTUAL)

December 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 581/3287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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