Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using A Visual Analog Scale
NCT ID: NCT05051748
Last Updated: 2021-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2019-09-08
2020-12-24
Brief Summary
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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 (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).
They were rated for "improvement in appearance" and "change in white/brown 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.
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Detailed Description
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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, pre-operative photographs were taken 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).
They were rated for "improvement in appearance" and "change in white/brown 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 2016.Improvement in appearance, change in opacity, tooth sensitivity, patient satisfaction and requirement for further treatment were not normally distributed (p\<0.05\*) i.e. nonparametric data, accordingly, Freidman's test to differentiate between timepoints and Kruskal-Wallis to compare between treatment protocols were applied at 0.05 level.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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In-office bleaching
40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA)
Opalescence™ boost™ PF 40%
40% hydrogen peroxide in-office bleaching
microabrasion
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA).
Opalustre™
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste
Remineralization
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA).
MI-Paste Plus®
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème
Microabrasion + In-office bleaching
teeth were treated with enamel microabrasion followed by in-office bleaching.
Opalescence™ boost™ PF 40%
40% hydrogen peroxide in-office bleaching
Opalustre™
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste
In-office bleaching + Remineralization
n-office bleaching was applied followed by MI-Paste Plus®
Opalescence™ boost™ PF 40%
40% hydrogen peroxide in-office bleaching
MI-Paste Plus®
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème
Microabrasion + Remineralization
microabrasion was applied followed by MI-Paste Plus®
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
Microabrasion + In-office bleaching + Remineralization
teeth were treated with microabrasion followed by in-office bleaching and lastly MI-Paste Plus®
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
Control
no treatment (control).
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Non-vital or teeth with symptoms of pulpitis
* Loss or fracture of maxillary and mandibular anterior teeth
20 Years
35 Years
ALL
Yes
Sponsors
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Suez Canal University
OTHER
Responsible Party
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Mostafa Nasser Abdelmoniem Youssef
Mostafa Nasser Abdelmoniem Youssef
Locations
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Faculty of dentistry, Suez canal university
Ismailia, , Egypt
Countries
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Other Identifiers
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202/2019
Identifier Type: -
Identifier Source: org_study_id
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