Color Masking Potential of Bioactive and ICON Materials

NCT ID: NCT06402500

Last Updated: 2024-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-12-31

Brief Summary

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The non cavitated white-spot lesion (WSL) occurs after sometime during fixed orthodontic treatments, and their treatment is mandatory before going into frank cavitation. The resin infiltration material (ICON, DMG, America) is considered to be the gold standard resin infiltrationmaterial used for WSL treatment. It is an efficient material in arresting WSLs and has high favorable esthetic recovery. Furthermore, biomaterials like bioactive glass adhesives HI-bond universal adhesive have always been used for replacement, repair and generation of dental hard tissues. The hypotheses of this study are:

1. There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration.
2. There will be no significant addition of mineral content into WSLs after treating it with bioactive glass adhesive HI-Bond universal or with ICON.

Detailed Description

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After sample size calculations were carried out a total sample size of 150 teeth will be included (75 teeth will be treated with ICON; and 75 other teeth will be treated with HI-Bond universal\].

Split mouth study design involves treating WSLs in two different quadrants in each participant. Treatments will be done according to manufacturer's instruction. The WSLs in the teeth of one quadrant will receive treatments with the ICON (DMG, America) , and the others in the opposite quadrant will receive treatments with the bioactive glass adhesive HI-Bond universal (MEDICLUS, south Korea).

Before receiving the treatment, the WSLs will be tested at baseline by Quantitative light-induced fluorescence (QLF) device then the test will be repeated at 1-month after the treatment for the quadrant that received bioactive glass adhesive.

Conditions

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White Spot Lesion of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth study design, patients will be assigned to two different treatment protocols.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.

Study Groups

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ICON resin group

Clean the white spot with prophylactic paste and then infiltrate the lesion with ICON resin.

Group Type EXPERIMENTAL

Icon Infiltrant

Intervention Type DRUG

White spot lesions are treated with the resin ICON (DMG, NJ, US) for masking their color. The mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.

Bioactive resin group

Clean the white spot with prophylactic paste and then infiltrate the lesion with bioactive resin.

Group Type EXPERIMENTAL

Bioactive infiltrant

Intervention Type DRUG

White spot lesions are treated with HI-Bond universal bioactive resin (MEDICLUS, south Korea) for masking their color. Mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.

Interventions

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Icon Infiltrant

White spot lesions are treated with the resin ICON (DMG, NJ, US) for masking their color. The mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.

Intervention Type DRUG

Bioactive infiltrant

White spot lesions are treated with HI-Bond universal bioactive resin (MEDICLUS, south Korea) for masking their color. Mineral content will be measured in the lesion at baseline and after one month Quantitative light-induced fluorescence QLF.

Intervention Type DRUG

Other Intervention Names

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ICON (DMG, NJ, US) MEDICLUS, Cheongju-si, south Korea

Eligibility Criteria

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Inclusion Criteria

1. Anterior and premolar maxillary and mandibular teeth.
2. Teeth with no previous restorations.
3. post-orthodontic white spot lesions WSL with no adjacent restorations in the same tooth.
4. WSL on Labial surfaces of maxillary or mandibular anterior and premolars teeth.

Exclusion Criteria

1. Cavitated enamel surface that requires direct composite restorations.
2. Presence of developmental enamel defects on the proposed teeth.
3. Diabetic patients and patients with metabolic syndrome.
4. Pregnant ladies.
5. Smoker patients.
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Abdullah University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zakereyya SM Albashaireh, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

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Jordan University of Science and Technology

Irbid, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Zakereyya SM Albashaireh, Ph.D

Role: CONTACT

0096227201000 ext. 23573

Malak Tallaq, BDS

Role: CONTACT

0096227201000 ext. 23573

Facility Contacts

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Zakereyya Albashaireh, PhD

Role: primary

0791015505

Other Identifiers

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JUST

Identifier Type: -

Identifier Source: org_study_id

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