Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05204277
Status:
COMPLETED
Last Update Posted:
2022-01-24
First Post:
2022-01-10
Brief Title:
Clinical Evaluation of Dental Fluororsis Treatment Modalities
Sponsor:
Suez Canal University
Organization:
Suez Canal University
Study Overview
Official Title:
Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using an Intra-oral Spectrophotometer
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n20 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
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 n20 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 66 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 n20 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 EL2a2b2 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 005 L a b and E were normally distributed p005 ie 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
Materials and Methods
Materials used in this study were Opalustre microabrasion paste of 66 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 n20 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 EL2a2b2 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 005 L a b and E were normally distributed p005 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None