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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05051748
Enrollment
16
Registered
2021-09-21
Start date
2019-09-08
Completion date
2020-12-24
Last updated
2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Fluorosis

Keywords

Bleaching, microabrasion, CPP-ACFP, VAS

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 (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.

Interventions

40% hydrogen peroxide in-office bleaching

6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste

casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Masking was ensured as the baseline and follow-ups photographs were stored on a computer with a unique ID and the investigators were not disclosed about the participants' treatment protocol. Blinding of the participants was guaranteed as they didn't know each other, or the treatments received in other protocols

Intervention model description

Fluorosed teeth

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient SatisfactionSix MonthsParticipants were asked to score for patient satisfaction using VAS ranging from 1 to 7

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026