Color Masking Potential of Bioactive and ICON Materials

NCT06402500 | Recruiting

• 1 other identifier: JUST
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.There will be no differences in color masking effect on WSLs managed by bioactive glass adhesive or ICON resin infiltration.
2. 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.

Conditions

White Spot Lesion of Tooth

Keywords

Resin infiltration; Incipient lesion; bioactive material; ICON infiltration resin

Outcome Measures

Primary Outcomes (2)

• Color masking potential of ICON material in white spot lesions in permanent teeth.

  Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 100-mm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.

  6 months

• Color masking potential of HI-Bond universal material in white spot lesions in permanent teeth.

  Photographs will be taken before, immediately after treatment, and 1-month after treatment. These photographs will be used for evaluating of the esthetic outcome by two groups of subjects. The first group comprises the patients themselves. The second group includes dentists. Participants in the evaluation process will will be based on a 10-cm visual analogue scale (VAS). Participants will draw a line on the scale indicating their satisfaction. A line drawn between 0 - 5 cm will mean unsatisfactory outcome while that drawn between 5 - 10 cm will indicate satisfactory outcome.

  6 months

Secondary Outcomes (3)

• The remineralisation potential of HI-Bond universal material of white spot lesion (WSL) in permanent teeth.

  3 months

• The remineralisation potential of HI-Bond universal material in the deepest point of the white spot lesion (WSL) in permanent teeth.

  3 months

• The remineralisation potential of HI-Bond universal material on lesion area (pixels) of white spot (WSL) in permanent teeth.

  3 months

Study Arms (2)

ICON resin group

EXPERIMENTAL

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

Drug: Icon Infiltrant

Bioactive resin group

EXPERIMENTAL

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

Drug: Bioactive infiltrant

Interventions

Icon Infiltrant 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.

Also known as: ICON (DMG, NJ, US)

ICON resin group

Bioactive infiltrant 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.

Also known as: MEDICLUS, Cheongju-si, south Korea

Bioactive resin group

Eligibility Criteria

• Age: 12 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Cavitated enamel surface that requires direct composite restorations.
• Presence of developmental enamel defects on the proposed teeth.
• Diabetic patients and patients with metabolic syndrome.
• Pregnant ladies.
• Smoker patients.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, 21110, Jordan

RECRUITING

MeSH Terms

Interventions

icon infiltrant

Study Officials

• Zakereyya SM Albashaireh, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zakereyya SM Albashaireh, Ph.D

CONTACT

0096227201000; albashai@just.edu.jo

Malak Tallaq, BDS

CONTACT

0096227201000; "Malak Tallaq" <malaktallaq@gmail.com>

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth study design, patients will be assigned to two different treatment protocols.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 7, 2024
• Study Start: December 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

JO (1)