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Resin Infiltration Treatment for MIH

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ClinicalTrials.gov Identifier: NCT04685889
Recruitment Status : Completed
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Halenur Altan, Tokat Gaziosmanpasa University

Study Description
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Brief Summary:
The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.

Condition or disease Intervention/treatment Phase
Molar Incisor Hypomineralization Enamel Hypoplasia Enamel Caries Anterior Teeth Procedure: Resin infiltration Not Applicable

Detailed Description:

A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control).

Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.

Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : June 23, 2018
Actual Study Completion Date : December 20, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Icon Group
Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.
 Procedure: Resin infiltration

A sufficient amount of HCl was applied to the lesion using the icon etch syringe included in the set and was allowed to sit for 2 minutes. After washing with water for 30 seconds, the tooth was dried using an air spray. Once the enamel surface appeared chalky, Icon® dry application was initiated.

Ethanol was applied to the lesion using the Icon® dry syringe included in the set, and after 30 seconds it was dried using an air spray. Sufficient amount of resin infiltrant was applied to the lesion using the Icon® infiltrant syringe. The resin infiltrant was applied to the lesion surface by massaging with the tip of the syringe in circular movements for 3 minutes such that it penetrates the surface thoroughly. The resin infiltrant was polymerized for 40 seconds with a light device.
No Intervention: Control Group
No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the Mineralisation degree [ Time Frame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later ]
    MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)

  2. Changes in the lesion colour [ Time Frame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later ]
    Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths)

  3. Lesion size evaluated using cross polarization technique [ Time Frame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later ]
    Changes in the MIH lesions size was evaluated using cross polarization technique


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH.

Exclusion Criteria:

  • Dental caries and filling on anterior teeth.
  • Dental anomaly on anterior teeth.
  • Undergoing orthodontic treatment.
  • Periodontal diseases.
  • Cognitive and behavioural problems.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685889


Locations
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Turkey
Gaziosmanpaşa University
Tokat, Turkey, 60100
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Study Director: Halenur Altan, assoc. prof. Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
Principal Investigator: Rabia Erağca Yılmaz, Msc. Dt. Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
More Information
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Publications:

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Responsible Party: Halenur Altan, Associated professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT04685889    
Other Study ID Numbers: 2018/35
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halenur Altan, Tokat Gaziosmanpasa University:
molar incisor hypomineralisation
resin infiltration
discoloration
enamel
lesion
Additional relevant MeSH terms:
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Dental Enamel Hypoplasia
Tooth Abnormalities
Stomatognathic System Abnormalities
 Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities