Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments

June 9, 2023 updated by: Sarah Mohamed Shafik Khalil, Beni-Suef University

Esthetic Management of Anterior Teeth Utilizing Two Micro Abrasion Treatments: Randomized Clinical Trial

the aim of this clinical trial is to compare the new micro-abrasion material "ANTIVET" compared to the conventional micro-abrasion material used widely "opalustre". to achieve better esthetics in cases of hypo-mineralized anterior permanent teeth of children and young adults.

both materials will be applied by the researchers and patient's teeth sensitivity and color change will be assessed immediately , after one month and after three months

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Materials and methods:

Enamel Microabrasion Even though only maxillary and mandibular hypominerlized incisors and canines were included in the current study, all teeth visible during smiling, laughing, or speaking were treated in this trial. The teeth were cleaned with pumice before treatment. Initial photographs of the teeth were taken.

Opalustre:

They were isolated with a rubber dam and then a fine-grit, water-cooled diamond bur was applied to the stained and white opaque enamel region for five to 10 seconds to enable penetration of the gel into the enamel. An approximately 1-mm- thick layer of 6.6% hydrochloric acid slurry with silicone carbide microparticles (Opalustre, Ultradent Products Inc, South Jordan, UT, USA) was applied to the affected tooth surfaces.

Antivet :

Teeth treated will be isolated first then Vaseline will be placed on gingival sulcus before placing dental dam., patient will be seated at a 45 degree angle. Five drops of Antivet in the plastic mixing well that comes. Then ANTIVET solution will be applied over the tooth's surface using a well condensed cotton pellet (approximately a 3 mm diameter). When the cotton pellet is pigmented by the tooth's staining, it will be changed for a new one. This process may take about 1 to 5 minutes per tooth, It should take no longer than 15 minutes from the moment the solution contacts the tooth's surface

Materials Treatment 1 opalustre Ultra dent Treatment 2 Antivet MDC

Sampling:

Thirty participants, aged between 9-18yrs, with dental hypo mineralized discolored anterior teeth and who met the following inclusion and exclusion criteria will be selected for the study.

Recruitment:

The two principal investigators and operators screened patients in Outpatient clinics of departments of Pediatric Dentistry and Public Health in Faculty of Dentistry - Beni-suef University & Restorative Dentistry- Faculty of Dentistry in the British University in Egypt irrespectively. The screening process was continued until the target population was achieved.

Patients will be randomly allocated in both treatment groups

Blinding:

Participants, outcome assessors and data analyst will be blinded to the interventions during the clinical trial. After complete data entry of the trial, they will be unblinded to avoid any bias to either two groups.

Outcome assessor chart was examined and filled up by two experts. Both investigators won't be involved in assessing the outcome. Informed Consent: both Investigators will be introduced the trial to patients regarding the main aspects of the trial.

A written informed consent forms (Arabic and English versions) were signed by all patients participated in the trial. The protocol, informed consent forms, participant education and recruitment materials will be reviewed and approved by the Ethical Committee of Faculty of Oral and Dental Medicine- Beni-Suef University.

outcomes will be assessed immediately after the procedure, 1 month and 3 months Pre-operative and post operative photographs will be taken to document color improvement in each visit

Study Type

Interventional

Enrollment (Actual)

30

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
    • Nasr City
      • Cairo, Nasr City, Egypt, 11765
        • Sarah Mohamed Shafik Khalil

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

participants having anterior teeth

  1. with Degree 1 (mild) according to the Wetzel and Reckel scale.: Isolated white and cream to yellowish brown discolorations on the chewing surface and upper part of the crown , for
  2. caries-free teeth.

Exclusion Criteria:

were children with :

  1. generalized hypoplasia
  2. amelogenesis imperfecta
  3. dentinogenesis imperfecta
  4. tetracycline or diffuse hypoplasia like fluorosis
  5. grossly broken and missing teeth where the reason of MIH could not be established.
  6. children with special health care needs.
  7. fractured, carious, grossly decayed 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: antivet arm
Teeth treated will be isolated first then Vaseline will be placed on gingival sulcus before placing dental dam., patient will be seated at a 45 degree angle. Five drops of Antivet in the plastic mixing well that comes. Then ANTIVET solution will be applied over the tooth's surface using a well condensed cotton pellet (approximately a 3 mm diameter). When the cotton pellet is pigmented by the tooth's staining, it will be changed for a new one. This process may take about 1 to 5 minutes per tooth, It should take no longer than 15 minutes from the moment the solution contacts the tooth's surface
Other: antivet
A material used for micro abrasion of teeth
Active Comparator: opulsture arm
They were isolated with a rubber dam and then a fine-grit, water-cooled diamond bur was applied to the stained and white opaque enamel region for five to 10 seconds to enable penetration of the gel into the enamel. An approximately 1-mm- thick layer of 6.6% hydrochloric acid slurry with silicone carbide microparticles (Opalustre, Ultradent Products Inc, South Jordan, UT, USA) was applied to the affected tooth surfaces.
Other: Oplsture
A material used for micro abrasion of teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative changes in teeth sensitivity
Time Frame: change from baseline teeth sensitivity immediately after treatment ,change from baseline teeth sensitivity after one month from treatment and change from baseline teeth sensitivity after three month from treatment after
visual analogue scale (0:no pain,10:worst pain) - verbal analogue scale (no pain or distressing, miserable pain )
change from baseline teeth sensitivity immediately after treatment ,change from baseline teeth sensitivity after one month from treatment and change from baseline teeth sensitivity after three month from treatment after
patient satisfaction
Time Frame: after 3 months

using a 5- point Likert scale ( 1= not at all satisfied, 5= extremely satisfied) likert scale: where 1 represents no improvement at all and 7 represents excellent improvement.

photography conditions will be standardized during pre and post treatment photos
after 3 months

Collaborators and Investigators

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

Sponsor

Beni-Suef University

Investigators

  • Principal Investigator: Sarah MS khalil, phD, lecturer of Pediatric Dentistry ,Faculty of Dentistry ,Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2022

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

November 1, 2022

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Estimated)

June 13, 2023

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • #REC-FDBSU/06102020-01/SS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

all Data will be available within 3 months

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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