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

NCT05051748 | Completed DMC

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

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.

Conditions

Dental Fluorosis

Keywords

Bleaching, microabrasion, CPP-ACFP, VAS

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  Participants were asked to score for "patient satisfaction" using VAS ranging from 1 to 7

  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

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

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 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mostafa Nasser Abdelmoniem Youssef

Model Details: Fluorosed teeth

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: September 21, 2021
• Study Start: September 8, 2019
• Primary Completion: May 6, 2020
• Study Completion: December 24, 2020
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)