Effect of Different Remineralization Gels

Effect of Different Remineralization Gels on the White Spot Lesions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: White Spot Lesion
• Intervention / Treatment: Other: Remineralization gel

Detailed Description

Oral hygiene training will be given to each group and a toothpaste containing 1450 ppm fluoride will be given to brush their teeth twice a day.

Essix appliance with reservoir will be made by taking impressions from 30 patients. Remineralization gel will be put into the Essix appliance for 5-7 minutes twice a day for one month.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betül Sen Yavuz, DDS; Phone Number: +905399887646; Email: dt.betulsen@gmail.com
• Study Contact Backup: Name: Dilanur Demiroglu, DDS; Phone Number: +905354911199; Email: dilanurdemiroglu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 15-18 years,
• Presence of white point lesions,
• Volunteering to participate in the research.

Exclusion Criteria:

• Not having received orthodontic treatment,
• Having a developmental anomaly affecting the enamel,
• Being allergic to milk,
• Having a syndrome affecting the oral cavity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No intervention.
Experimental: Remineralization gel with CPP- ACP (GC Tooth MousseTM, Tokyo, Japan); CPP-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).	Other: Remineralization gel; Remineralization gel
Experimental: Remineralization gel with calcium glycerophosphate (R.O.C.S.® Medical Mineral Gel, Russia); Remineralization 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).	Other: Remineralization gel; Remineralization gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP)	Decrease in laser fluorescence values with Diagnodent Pen as an indicator of remineralization	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calcium glycerophosphate	Decrease in laser fluorescence values with Diagnodent Pen as an indicator of remineralization	4 weeks

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 24, 2023
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: müdf.24.04.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No