Prevention of White Spot Lesions Using Bioactive Gel

July 13, 2023 updated by: Farah Khaled El Hindawy, Cairo University

Principal Investigator,Resident at Cairo University

white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. In this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. It is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment.

The incipient form of caries, white spot lesions (WSL), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . Orthodontic treatment is a major risk factor for the development of WSL. They are reported in up to 96% of orthodontic patients.

Many materials are being used to prevent white spot lesions with fluoride being the most commonly used . New materials have been emerged such as giomer based bioactive gel with the ability to release six ions Fluoride inhibits demineralization and promotes deposition of fluoroapatite. Aluminum helps to decrease demineralization as well by forming Alumino fluoro complexes. Borate reduces biofilm formation beside its antibacterial effect.

Silica promotes remineralization by inducing apatite nucleation on the tooth surface. Strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. Other ions such as Na act as strong base and have acid buffer capacity.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Phase 1

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients assigned for orthodontic treatment with fixed appliances
  • Sound teeth with fixed orthodontic appliances
  • Either maxillary or mandibular teeth or both

Exclusion Criteria:

  • Patients with poor oral hygiene
  • Allergic reaction to the materials used.
  • Lack of compliance.
  • xerostomia
  • Evidence of parafunctional habits.
  • Active carious lesions
  • Dental fluorosis
  • Hypocalcified teeth
  • Systemic diseases affecting teeth such as Amelogenesis imperfecta
  • Severe periodontal affection

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Application of bioactive gel on teeth in patients assigned for orthodontic treatment
Application of bioactive gel on labial/buccal surfaces of teeth is done according to manufacturer instructions using microbrush followed by light curing
Drug: giomer based bioactive gel
Application of bioactive gel to prevent white spot lesions in orthodontic patients
Active Comparator: Application of Fluoride on teeth in patients assigned for orthodontic treatment
Application of fluoride gel will be done using a gel loaded tray held in the mouth for 4 minutes .After removal of tray ,patients must spit out the residual gel. The use of suction is a must to avoid the problem of over ingestion
Drug: Fluoride gel
Application of fluoride gel to prevent white spot lesions in orthodontic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of white spot lesions using DIAGNOdent
Time Frame: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
the ability of the gels to prevent white spot lesions will be assessed using DIAGNOdent
Baseline,change from baseline at 3 months,6 months,9 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of white spot lesions using ICDAS (international caries detection and assessment system)
Time Frame: Baseline,change from baseline at 3 months,6 months,9 months and 12 months
the ability of the gels to prevent white spot lesions will be assessed using ICDAS
Baseline,change from baseline at 3 months,6 months,9 months and 12 months

Collaborators and Investigators

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

Sponsor

Cairo 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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 24, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Giomer based bioactive gel

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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