Clinical Evaluation of Dental Fluororsis Treatment Modalities

NCT05204277 | Completed DMC

• 1 other identifier: #202/2019
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Various treatment modalities are available to improve esthetics of fluorosed teeth based on its severity. Aim: evaluate the clinical performance of different minimal invasive treatment protocols on mild to moderate fluorosed teeth. Materials and Methods: Participants were randomly allocated in eight treatment protocols with twenty teeth (n=20) included in each protocol. (P1) Opalescence boost PF 40%. (P2) Opalustre. (P3) MI-Paste Plus. In (P4) teeth were treated with Opalustre + Opalescence boost PF 40%. In (P5) Opalescence boost PF 40% + MI-Paste Plus, while in (P6) Opalustre +MI-Paste Plus. Whereas (P7) Opalustre + Opalescence boost PF 40% + MI-Paste Plus. (P8) control. All teeth were evaluated for color change (∆E) immediately after treatment (T1), after 14 days (T2), after 3 months (T3) and after 6 months (T4). Statistical analysis: Two-way ANOVA was applied to test the interaction between different variables. ANOVA repeated measures were followed by Duncan multiple range tests (DMRTs) to compare between groups.

Conditions

Dental Fluorosis

Keywords

Bleaching, microabrasion, CPP-ACFP, color change, ∆E

Outcome Measures

Primary Outcomes (1)

• Color change (∆E)

  The color measurement was carried out 3 consecutive times with the same evaluator. At each time the obtained values were converted to the corresponding L, a and b values provided by the manufacturer and the mean of three measurements was taken. Color change was calculated from the formula ∆E=√((∆〖L)〗\^2+(∆〖a)〗\^2+〖(∆b)〗\^2 ) ,

  Six Months

Study Arms (8)

In-office bleaching

ACTIVE COMPARATOR

40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA)

Other: Opalescence™ boost™ PF 40%

microabrasion

ACTIVE COMPARATOR

6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA)

Other: Opalustre™

Remineralization

ACTIVE COMPARATOR

casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA).

Other: MI-Paste Plus®

Microabrasion + In-office bleaching

ACTIVE COMPARATOR

teeth were treated with enamel microabrasion followed by in-office bleaching.

Other: Opalescence™ boost™ PF 40%; Other: Opalustre™

In-office bleaching + Remineralization

ACTIVE COMPARATOR

In-office bleaching was applied followed by MI-Paste Plus®

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

Microabrasion + Remineralization

ACTIVE COMPARATOR

microabrasion was applied followed by MI-Paste Plus®

Other: Opalustre™; Other: MI-Paste Plus®

Microabrasion + In-office bleaching + Remineralization

ACTIVE COMPARATOR

teeth were treated with microabrasion followed by inoffice bleaching and lastly MI-Paste Plus®

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

Control

NO INTERVENTION

no treatment (control)

Interventions

Opalescence™ boost™ PF 40% OTHER

40% hydrogen peroxide in-office bleaching

In-office bleaching; In-office bleaching + Remineralization; Microabrasion + In-office bleaching; Microabrasion + In-office bleaching + Remineralization

Opalustre™ OTHER

6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste

Microabrasion + In-office bleaching; Microabrasion + In-office bleaching + Remineralization; Microabrasion + Remineralization; microabrasion

MI-Paste Plus® OTHER

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

In-office bleaching + Remineralization; Microabrasion + In-office bleaching + Remineralization; Microabrasion + Remineralization; Remineralization

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of dentistry, Suez canal university

Ismailia, Egypt

Location

MeSH Terms

Conditions

Fluorosis, Dental

Interventions

opalustre

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Masking was ensured as the baseline and follow-ups data 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mostafa Nasser Abdelmoniem Youssef

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: September 8, 2019
• Primary Completion: May 6, 2020
• Study Completion: December 24, 2020
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)