Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05051748
Status:
COMPLETED
Last Update Posted:
2021-09-21
First Post:
2021-09-11
Brief Title:
Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using A Visual Analog Scale
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 A Visual Analog Scale
Status:
COMPLETED
Status Verified Date:
2021-09
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:
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
One hundred and sixty fluorosed teeth were included in this study Prior to the interventions pre-operative photographs were taken 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
They were rated for improvement in appearance and change in whitebrown opaque areas using VAS through two blinded evaluators by comparing photographs of each follow-up time point with baseline Patient satisfaction tooth sensitivity and requirements for further treatments were recorded by the participant
One hundred and sixty fluorosed teeth were included in this study Prior to the interventions pre-operative photographs were taken 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
They were rated for improvement in appearance and change in whitebrown opaque areas using VAS through two blinded evaluators by comparing photographs of each follow-up time point with baseline Patient satisfaction tooth sensitivity and requirements for further treatments were recorded by the participant
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 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 pre-operative photographs were taken 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
They were rated for improvement in appearance and change in whitebrown opaque areas using VAS through two blinded evaluators by comparing photographs of each follow-up time point with baseline Patient satisfaction tooth sensitivity and requirements for further treatments were recorded by the participant
Data were collected checked revised and organized in tables and figures using Microsoft Excel 2016Improvement in appearance change in opacity tooth sensitivity patient satisfaction and requirement for further treatment were not normally distributed p005 ie nonparametric data accordingly Freidmans test to differentiate between timepoints and Kruskal-Wallis to compare between treatment protocols were applied at 005 level
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 pre-operative photographs were taken 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
They were rated for improvement in appearance and change in whitebrown opaque areas using VAS through two blinded evaluators by comparing photographs of each follow-up time point with baseline Patient satisfaction tooth sensitivity and requirements for further treatments were recorded by the participant
Data were collected checked revised and organized in tables and figures using Microsoft Excel 2016Improvement in appearance change in opacity tooth sensitivity patient satisfaction and requirement for further treatment were not normally distributed p005 ie nonparametric data accordingly Freidmans test to differentiate between timepoints and Kruskal-Wallis to compare between treatment protocols were applied at 005 level
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