Clinical trial NCT05204277: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Fluorosis
Keywords: Bleaching, microabrasion, CPP-ACFP, color change, ∆E
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Color change (∆E)
timeFrame: Six Months
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Faculty of dentistry, Suez canal university
Study officials:
References: