Clinical Evaluation of Dental Fluororsis Treatment Modalities

Dental Fluorosis Clinical Trial

Official title:

Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using an Intra-oral Spectrophotometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204277
• Other study ID #: #202/2019
• Status: Completed
• Phase: N/A
• Start date: September 8, 2019
• Est. completion date: December 24, 2020

Study information

• Verified date: January 2022
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 24, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Fluorosis
• Fluoride Poisoning
• Fluorosis, Dental

Intervention

Other:
• Opalescence™ boost™ PF 40%
40% hydrogen peroxide in-office bleaching
• Opalustre™
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste
• MI-Paste Plus®
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème

Locations

Country	Name	City	State
Egypt	Faculty of dentistry, Suez canal university	Ismailia

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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=v((??L)?^2+(??a)?^2+?(?b)?^2 ) ,	Six Months