Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth

November 4, 2026 updated by: Shaimaa Abdelrahman

Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth: A Randomized Clinical Trial

The aim of the study is to determine the effectiveness of minimally invasive treatments in reducing the visible enamel opacities on permanent anterior teeth in children aged from seven to twelve years with hypomineralized lesions.

A secondary purpose is to evaluate patient satisfaction and the psychosocial impact of the treatment on the esthetic perception of the treated children.

The results of all the research papers about treating enamel discoloration caused by hypomineralization with the ICON system can be accepted as satisfactory. However, not all cases achieved the full aesthetic aim.

Microabrasion is an acid abrasive removal and not the dissolution of enamel stain. It is as a treatment modality for enamel opacities like brown, orange, or yellow enamel spots; and fluorotic white streaks. Esthetic results could be reached when microabrasion followed by a remineralizing agent such as C PP-ACFP.

Null hypothesis, there is no difference between microabrasion followed by a remineralizing agent and resin infiltration treatment regarding clinical effectiveness & patient satisfaction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Outcomes:

Primary outcome Color enhancement using Clinical photographs (Bhandari, et al., 2019). Secondary outcomes

  • Patient satisfaction will be evaluated using Numerical scale (NS), (Figure 1). The participant marked the number that represented their self-assessed satisfaction (Rocha et al., 2020) as shown in Appenxix II.
  • Psychosocial impact of the treatment on the esthetic perception of the treated children will be evaluated using The Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) (Klages et al., 2006). Appendix III.
  • Reducing teeth hypersensitivity will be evaluated using The Schiff Cold Air Sensitivity Scale (SCASS) (Schiff et al., 1994).
  • Adverse and undesirable side effects experienced by the respondents: a) pain in teeth and gums will be evaluated using The Wong-Baker FACES® Pain Rating Scale (Wong et al., 1988). Appendix IV.
  • b) bitter taste will be evaluated by asking the child right after treatment. (Athayde et al., 2022).
  • Follow up:

Follow up after 1 day for adverse and undesirable side effects, 1week & 6 months.

Randomization:

The participants will be randomly assigned to one of the three experimental groups the interventions and control groups using simple randomization with a 1:1 allocation ratio.

Masking/blinding:

Neither the operator nor the patients could be blinded due to the nature of the study but the outcome assessor and statistician will be blinded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ▪ Participants free from any systemic disease aged from 7 years to 12 years

    • Anterior permanent teeth with Degree 1(mild) hypomineralization (according to the Wetzel and Reckel scale) (as shown in Appenxix I).
    • Enamel opacities, (White, creamy or yellow to brownish colour), without enamel breakdown
    • Caries-free teeth.
    • Sensitivity to external stimuli e.g., air/water but not brushing.

Exclusion Criteria:

  • ▪ Dental caries and filling,

    • Loss of the enamel or dentin structure,
    • Clinical symptoms of irreversible pulpitis such as spontaneous pain or persisting pain,
    • Previous use of bleaching agent.
    • Dental anomaly on anterior teeth,
    • Periodontal diseases,
    • Undergoing orthodontic treatment,
    • Cognitive and behavioral conditions.
    • Patients with milk protein or hydroxybenzoates allergies.

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control group ICON® resin infiltration

Resin infiltration treatment (Icon®) for Hypomineralized anterior permanent teeth in children
Other: ICON® resin infiltration
  • Applying a 15% hydrochloric acid gel (ICON-Etch; DMG; Hamburg, Germany®) for 120 s using the Icon® etch syringe included in the set,
  • followed by a thorough washing of the etchant for 30 s. and Dring the tooth using an air spray,
  • Once the enamel surface appeared chalky, Ethanol lesion desiccation (ICON-Dry; DMG®) will be performed for 30 s,
  • followed by drying using an air spray.
  • Using the Icon® infiltrant syringe Infiltration with a sufficient amount resin (ICON-Infiltrate; DMG®) of the lesion surface by massaging the tip of the syringe on the lesion in circular movements for 3 min.
  • Before drying, clean the remaining material and excess removal by Gauze or cotton swab and dental floss.
  • Light curing for 40 s with a light-cure device,
  • Then another round of infiltration will take place
  • One minute was provided for the material to infiltrate the pores, after which it was polymerized for 40 s.
Experimental: Intervention group 1

Opalustre® Enamel Microabrasion Slurry
Other: Opalustre® enamel microabrasion
  • Isolation is extremely important because of the hydrochloric acid. Patients and clinician should both wear protective eyewear.
  • Isolate teeth to be treated and one tooth posterior on each side using rubber dam.
  • For additional protection, apply a bead of rubber dam sealer or light-cured resin barrier at the gingival margin beneath the dam.

NOTE: For hypo-mineralization greater than 0.1-0.3mm use a fine-grit water-cooled tapered diamond bur, lightly sweep over the stained area for 5-10 seconds prior to applying Opalustre.

  • Apply approximately 1.0mm thick layer over the discolored area from Opalustre syringe with the White Mac tip.
  • Using a rubber prophy cup at a slow RPM (approximately 500 RPM), apply medium to heavy pressure for 60 seconds at a time.
  • Suction the paste from the teeth first, then rinse, evaluate and repeat as necessary.
  • Aesthetic improvement should be visualized on the wet surfaces.
  • After final rinse, remove rubber dam, and sealer from the teeth. Rinse
Experimental: Intervention group 2

Antivet® enamel micro-abrasion
Other: Antivet® enamel micro-abrasion
  • The Antivet® abrasive solution (MDC DENTAL, Zapopan Jalisco, México) containing 21% hydrofluoric acid will be placed on the buccal surface with a cotton swab.
  • When the swab became pigmented, it will change to another clean swab with the abrasive solution.
  • The procedure would be repeated for 10 min.
  • When the process is finished, the excess solution will be cleaned using cotton, and calcium hydroxide as a neutralizing solution would be placed for 1 min with a micro brush.
  • In the end, rinsing with water for 30 s.
  • Apply MI varnish to the enamel.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Color enhancement measured by Clinical photographs
Time Frame: 6 months

Clinical photographs will be taken with a digital camera macro lens, and flash. With the patient and digital camera at the same vertical plane and dental clinic illuminated evenly.

The photographs will be taken in baseline, during the application time of the test or control.

For standardizing the photographic conditions, the camera will be placed at the equidistance from the tooth. To prevent the change of refractive index by moisture, 30 s of drying of the lesion will be done.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction measured by Visual analogue scale
Time Frame: 6 months

The patient is asked to draw a line perpendicular to the VAS at their perceived pain-intensity level, no discomfort (score 0), mild discomfort (score 1-3), moderate (score 4-6) and very severe (7-9) or worst discomfort (score 10).
6 months
Reducing teeth hypersensitivity measured by The Schiff Cold Air Sensitivity Scale (SCASS)
Time Frame: 6 months

It is a behavioral scale because it is based on observed behavior in response to a stimulus beyond a certain threshold.

The dentist (or another assessor present) rates the response of the patient to the stimulus as 0 for no response to air stimulus,

  1. for response to air stimulus but no request for discontinuation of the stimulus,
  2. for response to air stimulus and requests discontinuation or moves from the stimulus&
  3. for response to air stimulus, considers stimulus to be painful, and requests discontinuation'
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaimaa Abdelrahman

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shaimaa AM Awad, Mcs, Cairo Uviversity

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 261711198415920202321948291954

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings