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

September 11, 2021 updated by: Mostafa Nasser Abdelmoniem Youssef, Suez Canal University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Faculty of dentistry, Suez Canal university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Six Months
Participants were asked to score for "patient satisfaction" using VAS ranging from 1 to 7
Six Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 8, 2019

Primary Completion (ACTUAL)

May 6, 2020

Study Completion (ACTUAL)

December 24, 2020

Study Registration Dates

First Submitted

September 11, 2021

First Submitted That Met QC Criteria

September 11, 2021

First Posted (ACTUAL)

September 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 11, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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