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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05948228
Other study ID # Giomer based bioactive gel
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date August 2023
Est. completion date January 2025

Study information

Verified date July 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 330
Est. completion date January 2025
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 28 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
giomer based bioactive gel
Application of bioactive gel to prevent white spot lesions in orthodontic patients
Fluoride gel
Application of fluoride gel to prevent white spot lesions in orthodontic patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of white spot lesions using DIAGNOdent 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 incidence of white spot lesions using ICDAS (international caries detection and assessment system) 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
See also
  Status Clinical Trial Phase
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Not yet recruiting NCT03990935 - Remineralization Potential of Ginger and Rosemary Herbals Versus Sodium Fluoride in Treatment of White Spot Lesions N/A
Not yet recruiting NCT02912741 - One Year Clinical Evaluation of White Spot Lesions Treated With Newly Introduced Resin Modified Glass Ionomer in Comparison to Resin Infiltration in Anterior Teeth Split Mouth Technique Phase 2
Completed NCT01881100 - Randomized Trial on Resin Infiltration in Deciduous Teeth N/A
Completed NCT05562856 - Clinical Evaluation of White Spot Lesions Treated by S-PRG Material and Composite Sealants in Comparison With ICON N/A
Completed NCT01500187 - Fluoride Varnish for Treatment of White Spot Lesions N/A
Completed NCT02341872 - Compare the Efficacy of the Remineralization Agents on the White Enamel Lesions N/A