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

Primary Purpose

Dental Fluorosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Opalescence™ boost™ PF 40%
Opalustre™
MI-Paste Plus®
Sponsored by
Suez Canal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Fluorosis focused on measuring Bleaching, microabrasion, CPP-ACFP, VAS

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of dentistry, Suez canal university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

In-office bleaching

microabrasion

Remineralization

Microabrasion + In-office bleaching

In-office bleaching + Remineralization

Microabrasion + Remineralization

Microabrasion + In-office bleaching + Remineralization

Control

Arm Description

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

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

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

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

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

microabrasion was applied followed by MI-Paste Plus®

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

no treatment (control).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2021
Last Updated
September 11, 2021
Sponsor
Suez Canal University
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1. Study Identification

Unique Protocol Identification Number
NCT05051748
Brief Title
Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using A Visual Analog Scale
Official Title
Clinical Evaluation of Different Minimal Invasive Treatment Modalities of Mild to Moderate Dental Fluorosis Using A Visual Analog Scale
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 8, 2019 (Actual)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
December 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Fluorosis
Keywords
Bleaching, microabrasion, CPP-ACFP, VAS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Fluorosed teeth
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-office bleaching
Arm Type
Active Comparator
Arm Description
40% hydrogen peroxide in-office bleaching (Opalescence™ boost™ PF 40%, Ultradent Products, Inc., South Jordan, UT, USA)
Arm Title
microabrasion
Arm Type
Active Comparator
Arm Description
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste (Opalustre™, Ultradent Products, Inc., South Jordan, UT, USA).
Arm Title
Remineralization
Arm Type
Active Comparator
Arm Description
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème (MI-Paste Plus®, GC America Inc., USA).
Arm Title
Microabrasion + In-office bleaching
Arm Type
Active Comparator
Arm Description
teeth were treated with enamel microabrasion followed by in-office bleaching.
Arm Title
In-office bleaching + Remineralization
Arm Type
Active Comparator
Arm Description
n-office bleaching was applied followed by MI-Paste Plus®
Arm Title
Microabrasion + Remineralization
Arm Type
Active Comparator
Arm Description
microabrasion was applied followed by MI-Paste Plus®
Arm Title
Microabrasion + In-office bleaching + Remineralization
Arm Type
Active Comparator
Arm Description
teeth were treated with microabrasion followed by in-office bleaching and lastly MI-Paste Plus®
Arm Title
Control
Arm Type
No Intervention
Arm Description
no treatment (control).
Intervention Type
Other
Intervention Name(s)
Opalescence™ boost™ PF 40%
Intervention Description
40% hydrogen peroxide in-office bleaching
Intervention Type
Other
Intervention Name(s)
Opalustre™
Intervention Description
6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste
Intervention Type
Other
Intervention Name(s)
MI-Paste Plus®
Intervention Description
casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
Participants were asked to score for "patient satisfaction" using VAS ranging from 1 to 7
Time Frame
Six Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of dentistry, Suez canal university
City
Ismailia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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