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

S

Suez Canal University

Status

Completed

Conditions

Dental Fluorosis

Treatments

Other: MI-Paste Plus®
Other: Opalescence™ boost™ PF 40%
Other: Opalustre™

Study type

Interventional

Funder types

Other

Identifiers

NCT05051748
202/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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
  • Non-vital or teeth with symptoms of pulpitis
  • Loss or fracture of maxillary and mandibular anterior teeth

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

16 participants in 8 patient groups

In-office bleaching
Active Comparator group
Description:
40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA)
Treatment:
Other: Opalescence™ boost™ PF 40%
microabrasion
Active Comparator group
Description:
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA).
Treatment:
Other: Opalustre™
Remineralization
Active Comparator group
Description:
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA).
Treatment:
Other: MI-Paste Plus®
Microabrasion + In-office bleaching
Active Comparator group
Description:
teeth were treated with enamel microabrasion followed by in-office bleaching.
Treatment:
Other: Opalescence™ boost™ PF 40%
Other: Opalustre™
In-office bleaching + Remineralization
Active Comparator group
Description:
n-office bleaching was applied followed by MI-Paste Plus®
Treatment:
Other: Opalescence™ boost™ PF 40%
Other: MI-Paste Plus®
Microabrasion + Remineralization
Active Comparator group
Description:
microabrasion was applied followed by MI-Paste Plus®
Treatment:
Other: Opalustre™
Other: MI-Paste Plus®
Microabrasion + In-office bleaching + Remineralization
Active Comparator group
Description:
teeth were treated with microabrasion followed by in-office bleaching and lastly MI-Paste Plus®
Treatment:
Other: Opalescence™ boost™ PF 40%
Other: Opalustre™
Other: MI-Paste Plus®
Control
No Intervention group
Description:
no treatment (control).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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