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

4. november 2026 opdateret af: 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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

69

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

7 år til 12 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control group ICON® resin infiltration

Resin infiltration treatment (Icon®) for Hypomineralized anterior permanent teeth in children

  • 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.
Eksperimentel: Intervention group 1

Opalustre® Enamel Microabrasion Slurry

  • 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
Eksperimentel: Intervention group 2

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Color enhancement measured by Clinical photographs
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient satisfaction measured by Visual analogue scale
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Shaimaa AM Awad, Mcs, Cairo Uviversity

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

24. oktober 2026

Først indsendt, der opfyldte QC-kriterier

24. oktober 2026

Først opslået (Faktiske)

30. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. september 2026

Mere information

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