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Clinical Evaluation of Dental Fluororsis Treatment Modalities

Primary Purpose

Dental Fluorosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Opalescence™ boost™ PF 40%
Opalustre™
MI-Paste Plus®
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Fluorosis focused on measuring Bleaching, microabrasion, CPP-ACFP, color change, ∆E

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Each participant had at least 8 teeth with mild to moderate dental fluorosis score 1-4 according to Thylstrup and Fejerskov index.

    • Participants of age range 20-35 years old
    • Good oral and general health
    • Had no caries or restorations on the teeth to be treated
    • Ability to return for periodic recalls

Exclusion Criteria:

  • Hypersensitive teeth
  • Any fixed orthodontic appliance
  • Current or previous use of bleaching agents
  • A history of allergies to tooth whitening product
  • Smoking habits
  • Pregnant or lactating women

Sites / Locations

  • Faculty of dentistry, Suez canal university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

In-office bleaching

microabrasion

Remineralization

Microabrasion + In-office bleaching

In-office bleaching + Remineralization

Microabrasion + Remineralization

Microabrasion + In-office bleaching + Remineralization

Control

Arm Description

40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA)

6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA)

casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA).

teeth were treated with enamel microabrasion followed by in-office bleaching.

In-office bleaching was applied followed by MI-Paste Plus®

microabrasion was applied followed by MI-Paste Plus®

teeth were treated with microabrasion followed by inoffice bleaching and lastly MI-Paste Plus®

no treatment (control)

Outcomes

Primary Outcome Measures

Color change (∆E)
The color measurement was carried out 3 consecutive times with the same evaluator. At each time the obtained values were converted to the corresponding L, a and b values provided by the manufacturer and the mean of three measurements was taken. Color change was calculated from the formula ∆E=√((∆〖L)〗^2+(∆〖a)〗^2+〖(∆b)〗^2 ) ,

Secondary Outcome Measures

Full Information

First Posted
January 10, 2022
Last Updated
January 10, 2022
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05204277
Brief Title
Clinical Evaluation of Dental Fluororsis Treatment Modalities
Official Title
Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using an Intra-oral Spectrophotometer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 8, 2019 (Actual)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
December 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Various treatment modalities are available to improve esthetics of fluorosed teeth based on its severity. Aim: evaluate the clinical performance of different minimal invasive treatment protocols on mild to moderate fluorosed teeth. Materials and Methods: Participants were randomly allocated in eight treatment protocols with twenty teeth (n=20) included in each protocol. (P1) Opalescence boost PF 40%. (P2) Opalustre. (P3) MI-Paste Plus. In (P4) teeth were treated with Opalustre + Opalescence boost PF 40%. In (P5) Opalescence boost PF 40% + MI-Paste Plus, while in (P6) Opalustre +MI-Paste Plus. Whereas (P7) Opalustre + Opalescence boost PF 40% + MI-Paste Plus. (P8) control. All teeth were evaluated for color change (∆E) immediately after treatment (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4). Statistical analysis: Two-way ANOVA was applied to test the interaction between different variables. ANOVA repeated measures were followed by Duncan multiple range tests (DMRTs) to compare between groups.
Detailed Description
This study was conducted for clinical evaluation of the quality of different minimal-invasive treatment modalities and combination treatments in esthetics improvement of mild to moderate fluorosed teeth using two different evaluation methods. Materials and Methods: Materials used in this study were Opalustre™ (microabrasion paste of 6.6% hydrochloric acid and Silicon Carbide), Opalescence™ Boost™ PF 40% (in-office bleaching of 40% hydrogen peroxide) and MI-Paste Plus® (topical remineralizing tooth crème of casein phosphopeptide amorphous calcium fluoride phosphate). One hundred and sixty fluorosed teeth were included in this study. Prior to the interventions, tooth color coordinates were clinically recorded by VITA Easyshade V based on CIE Lab color system as baseline records. After that teeth were randomly allocated in eight treatment protocols with twenty teeth (n=20) included in each protocol. Protocol one (P1) Opalescence™ boost™ PF 40%. Protocol two (P2) Opalustre™. Protocol three (P3) MI-Paste Plus®. In protocol four (P4) teeth were treated with Opalustre™ followed by Opalescence™ boost™ PF 40%. In protocol five (P5) Opalescence™ boost™ PF 40% was applied followed by MI-Paste Plus®, while in protocol six (P6) Opalustre™ was applied followed by MI-Paste Plus®. Whereas protocol seven (P7) teeth were treated with Opalustre™ followed by Opalescence™ boost™ PF 40% and lastly MI-Paste Plus®. Protocol eight (P8) control. All teeth were evaluated immediately after treatment (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4). Color change was calculated from the formula ∆E=√((∆〖L)〗^2+(∆〖a)〗^2+〖(∆b)〗^2 ) , where ∆L, ∆a and ∆b were the difference between readings mean values at different evaluating times from the baseline readings. Photographs were taken; immediately after application (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4). Data were collected, checked, revised and organized in tables and figures using Microsoft Excel 2016. Data were checked for normality using Kolmogorov-Smirnov at 0.05. ∆L, ∆a, ∆b, and ∆E were normally distributed (p>0.05) i.e. parametric data, two-way ANOVA was applied to test the interaction between different variables. ANOVA repeated measures were followed by Duncan multiple range tests (DMRTs) to compare between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Fluorosis
Keywords
Bleaching, microabrasion, CPP-ACFP, color change, ∆E

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Masking was ensured as the baseline and follow-ups data were stored on a computer with a unique ID and the investigators were not disclosed about the participants' treatment protocol. Blinding of the participants was guaranteed as they didn't know each other, or the treatments received in other protocols
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-office bleaching
Arm Type
Active Comparator
Arm Description
40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA)
Arm Title
microabrasion
Arm Type
Active Comparator
Arm Description
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA)
Arm Title
Remineralization
Arm Type
Active Comparator
Arm Description
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA).
Arm Title
Microabrasion + In-office bleaching
Arm Type
Active Comparator
Arm Description
teeth were treated with enamel microabrasion followed by in-office bleaching.
Arm Title
In-office bleaching + Remineralization
Arm Type
Active Comparator
Arm Description
In-office bleaching was applied followed by MI-Paste Plus®
Arm Title
Microabrasion + Remineralization
Arm Type
Active Comparator
Arm Description
microabrasion was applied followed by MI-Paste Plus®
Arm Title
Microabrasion + In-office bleaching + Remineralization
Arm Type
Active Comparator
Arm Description
teeth were treated with microabrasion followed by inoffice bleaching and lastly MI-Paste Plus®
Arm Title
Control
Arm Type
No Intervention
Arm Description
no treatment (control)
Intervention Type
Other
Intervention Name(s)
Opalescence™ boost™ PF 40%
Intervention Description
40% hydrogen peroxide in-office bleaching
Intervention Type
Other
Intervention Name(s)
Opalustre™
Intervention Description
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste
Intervention Type
Other
Intervention Name(s)
MI-Paste Plus®
Intervention Description
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème
Primary Outcome Measure Information:
Title
Color change (∆E)
Description
The color measurement was carried out 3 consecutive times with the same evaluator. At each time the obtained values were converted to the corresponding L, a and b values provided by the manufacturer and the mean of three measurements was taken. Color change was calculated from the formula ∆E=√((∆〖L)〗^2+(∆〖a)〗^2+〖(∆b)〗^2 ) ,
Time Frame
Six Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Each participant had at least 8 teeth with mild to moderate dental fluorosis score 1-4 according to Thylstrup and Fejerskov index. Participants of age range 20-35 years old Good oral and general health Had no caries or restorations on the teeth to be treated Ability to return for periodic recalls Exclusion Criteria: Hypersensitive teeth Any fixed orthodontic appliance Current or previous use of bleaching agents A history of allergies to tooth whitening product Smoking habits Pregnant or lactating women
Facility Information:
Facility Name
Faculty of dentistry, Suez canal university
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Evaluation of Dental Fluororsis Treatment Modalities

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