Effect of Different Remineralization Gels
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
The aim of the study is to treat white spot lesions that occur after orthodontic treatment. Different gels will be used for remineralization. The study will consist of 45 people between the ages of 15-18. 45 people will be divided into 3 groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Typical duration for not_applicable
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 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
May 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedMay 22, 2023
May 1, 2023
1.4 years
April 24, 2023
May 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)
Decrease in laser fluorescence values with Diagnodent Pen as an indicator of remineralization
4 weeks
Secondary Outcomes (1)
Calcium glycerophosphate
4 weeks
Study Arms (3)
Remineralization gel with CPP- ACP (GC Tooth MousseTM, Tokyo, Japan)
EXPERIMENTALCPP-ACP containing remineralization gel (Tooth Mousse GC, Tokyo, Japan) will be put into the Essix appliance with a reservoir and applied for 5-7 minutes twice a day for one month. Before and after the applying remineralization gel, the laser fluorescence values will measure with a DIAGNOdent pen (KaVo Dental corporation, East Main street Lake Zurich, lL).
Remineralization gel with calcium glycerophosphate (R.O.C.S.® Medical Mineral Gel, Russia)
EXPERIMENTALRemineralization gel containing calcium glycerophosphate (R.O.C.S.® Medical Minerals Gel, Russia) will be put into the Essix appliance with a reservoir for 5-7 minutes twice a day for one month. Before and after the applying remineralization gel, the laser fluorescence values will measure with a DIAGNOdent pen( KaVo Dental corporation, East Main street Lake Zurich, lL).
Control Group
NO INTERVENTIONNo intervention.
Interventions
Remineralization gel
Eligibility Criteria
You may qualify if:
- Patients aged 15-18 years,
- Presence of white point lesions,
- Volunteering to participate in the research.
You may not qualify if:
- Not having received orthodontic treatment,
- Having a developmental anomaly affecting the enamel,
- Being allergic to milk,
- Having a syndrome affecting the oral cavity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 24, 2023
First Posted
May 22, 2023
Study Start
May 24, 2023
Primary Completion
October 1, 2024
Study Completion
April 1, 2025
Last Updated
May 22, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share