NCT05051748

Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using A Visual Analog Scale

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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 (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.

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 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

• Dental Fluorosis

Interventions

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

Timeline

• Start date: 2019-09-08
• Primary completion: 2020-05-06
• Completion: 2020-12-24
• First posted: 2021-09-21
• Last updated: 2021-09-21

Locations

1 site across 1 country: Egypt