Clinical Evaluation of the Efficacy of SPR-G Barrier Coat Versus Fluoride Varnish Versus MI Paste in the Treatment of Early White Spot Lesions in Pediatric Patients
Primary Purpose
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
PRG Barrier Coat
Fluoride varnish
MI paste
Sponsored by
About this trial
This is an interventional treatment trial for White Spot Lesions [Initial Caries] on Smooth Surface of Tooth focused on measuring White spot lesions, Fluoride varnish, MI paste (CPP_ACP), SPRG- Barrier coat
Eligibility Criteria
Inclusion Criteria:
- Aged 10-16 years old
- Patient is healthy and medically free.
- Moderate to high level of patient cooperation
- Compliance of the primary caregiver
- Moderate to high caries risk
- Completed or in transitional fixed orthodontic treatment
- At least 1 wsl should be present
Exclusion Criteria:
- Poor oral hygiene
- Deeply Cavitated white spot lesions
- Medically Compromised patients.
- Extremely Uncooperative patient or primary caregiver
- Generalized white spot lesions in the mouth
Sites / Locations
- Ain Shams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Active Comparator
Arm Label
group of 20 participants receiving fluoride varnish
group of 20 participants receiving PR-G Barrier coat
group of 20 participants receiving MI Paste (CPP-ACP)
Arm Description
*Group (I): patients will receive Fluoride varnish ttt.
*Group (II): patients will receive PR-G Barrier coat
*Group (III): Patients will receive MI Paste (CPP-ACP)
Outcomes
Primary Outcome Measures
Change in the size of the white spot lesions using photographic assessment
participants are divided into 3 groups. Each group receiving a different management approach to find out the most effective drug in reducing the size of white spot lesions. Photos are taken pre-operatively. 1 month, 3 months and 9 months
Secondary Outcome Measures
Remineralization of the enamel surface
Using photographic assessment with the aid of a software to asses the change in the height and width (i.e surface area) of the white spot lesion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05202821
Brief Title
Clinical Evaluation of the Efficacy of SPR-G Barrier Coat Versus Fluoride Varnish Versus MI Paste in the Treatment of Early White Spot Lesions in Pediatric Patients
Official Title
Clinical Evaluation of the Efficacy of SPR-G (Surface Pre-reacted Glass Ionomer) Barrier Coat Versus Fluoride Varnish Versus the MI Paste (CPP-ACP) in the Treatment of Early White Spot Lesions in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In-Vivo randomized clinical trial to compare between the clinical performance of fluoride varnish versus MI paste (CPP_ACP) and the PRG- Barrier coat material concerning enamel remineralization, arrest of active early lesions, resolution of inactive incipient lesions and patient satisfaction and motivation with a 9-months follow up using a high resolution Nikon camera with Canon 700D body. Canon EF 100mm f2.8 USM Macro Lens and Nissin MF18 ring flash Canon fit for better illumination. Also, A set of retractors and A set child occlusal mirrors with A contraster for assessment of the remineralization progress of the white spot lesion.
Detailed Description
A total of sixty (60) patients with early white spot lesions will be randomly selected to share in this study from the out-patient clinic of pedodontics and orthodontic department, Faculty of dentistry, Ain Shams University.
An informed consent will be signed by the patients and parents before their enrollment in the current study in which the aim of the study, the methodology and possible complications will be clearly described. This research will be reviewed by the research ethics committee, Faculty of dentistry, Ain Shams University. This In-vivo study will aim to evaluate the effectiveness of the SPR-G filler material sealants when compared to the fluoride varnish and the MI paste.
Precise medical, dental and family history will be taken from all patients through a direct interview and diagnostic sheet.
Teeth will be polished using a polishing brush and paste, and dried thoroughly before being examined.
Clinical examination will be done using a dental mirror and aided by the tactile detection of a dental explorer under LED illumination to make sure that the patients fulfill the inclusion criteria, followed by radiographic examination. All examination and follow up procedures will be done by the same operator to ensure standardization.
Patient's Grouping:
Selected patients will be randomly divided into three groups:
Group (I): patients will receive Fluoride varnish ttt.
Group (II): patients will receive PR-G Barrier coat
Group (III): Patients will receive MI Paste (CPP-ACP)
Patients who fail to show up at the follow up examinations will be automatically excluded from the study. Patients who are no longer willing to continue in the study will have the right to quit at any time.
Patient information will be gathered and stored in the patient examination chart of the outpatient clinic, Department of Pediatric Dentistry, faculty of Dentistry, Ain Shams University. All information will be kept as a hard copy and as an electronic one as well. Patient information will be guarded as confidential information that should never be revealed at all times. This file will remain with the investigator during the study.
Outcome measurement:
9 months' in vivo evaluation of functional & biological aspects of the three modalities regarding retention, stability, oral hygiene and patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Keywords
White spot lesions, Fluoride varnish, MI paste (CPP_ACP), SPRG- Barrier coat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group of 20 participants receiving fluoride varnish
Arm Type
Active Comparator
Arm Description
*Group (I): patients will receive Fluoride varnish ttt.
Arm Title
group of 20 participants receiving PR-G Barrier coat
Arm Type
Experimental
Arm Description
*Group (II): patients will receive PR-G Barrier coat
Arm Title
group of 20 participants receiving MI Paste (CPP-ACP)
Arm Type
Active Comparator
Arm Description
*Group (III): Patients will receive MI Paste (CPP-ACP)
Intervention Type
Drug
Intervention Name(s)
PRG Barrier Coat
Other Intervention Name(s)
SPRG Barrier Coat
Intervention Description
3 arm randomized single blind clinical trial comparing 3 groups. first group will be receiving fluoride varnish, second group will be receiving PRG Barrier Coat and the third group will be receiving MI paste
Intervention Type
Drug
Intervention Name(s)
Fluoride varnish
Other Intervention Name(s)
Cavity Shield
Intervention Description
First group will be receiving Fluoride varnish every 3 months
Intervention Type
Drug
Intervention Name(s)
MI paste
Other Intervention Name(s)
RECALDENT™, (CPP-ACP)
Intervention Description
Third group will be receiving MI paste
Primary Outcome Measure Information:
Title
Change in the size of the white spot lesions using photographic assessment
Description
participants are divided into 3 groups. Each group receiving a different management approach to find out the most effective drug in reducing the size of white spot lesions. Photos are taken pre-operatively. 1 month, 3 months and 9 months
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Remineralization of the enamel surface
Description
Using photographic assessment with the aid of a software to asses the change in the height and width (i.e surface area) of the white spot lesion
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
Patient satisfaction and motivation towards treatment using a questionnaire at the end of the treatment
Description
Closed ended questions with strongly agree rated with 5, agree rated 4, neutral rated 3, disagree rated 2 and strongly disagree rated 1. Higher values will denote positive results lower values indicating negative results
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 10-16 years old
Patient is healthy and medically free.
Moderate to high level of patient cooperation
Compliance of the primary caregiver
Moderate to high caries risk
Completed or in transitional fixed orthodontic treatment
At least 1 wsl should be present
Exclusion Criteria:
Poor oral hygiene
Deeply Cavitated white spot lesions
Medically Compromised patients.
Extremely Uncooperative patient or primary caregiver
Generalized white spot lesions in the mouth
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Elsagheer, Master's Candidate
Phone
00201096735935
Ext
002010
Email
elsagheermariam@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Zayed, Assistant Professor
Phone
+20111148002
Ext
002011
Email
Mradwan@dent.asu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Abd El Aziz, Professor
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University
City
Cairo
State/Province
Al Waili
ZIP/Postal Code
11566
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Zayed, Assistant Professor
Phone
+20111148002
Email
Mradwan@dent.asu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mariam Alsagheer, Master's Candidate
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
9 months
Learn more about this trial
Clinical Evaluation of the Efficacy of SPR-G Barrier Coat Versus Fluoride Varnish Versus MI Paste in the Treatment of Early White Spot Lesions in Pediatric Patients
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