Resin Infiltration Treatment for MIH

NCT04685889 | Completed

• 1 other identifier: 2018/35
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Molar Incisor Hypomineralization; Enamel Hypoplasia; Enamel Caries; Anterior Teeth

Keywords

molar incisor hypomineralisation; resin infiltration; discoloration; enamel; lesion

Outcome Measures

Primary Outcomes (3)

• Changes in the Mineralisation degree

  MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)

  Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later

• Changes in the lesion colour

  Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths)

  Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later

• Lesion size evaluated using cross polarization technique

  Changes in the MIH lesions size was evaluated using cross polarization technique

  Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later

Study Arms (2)

Icon Group

ACTIVE COMPARATOR

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

Control Group

NO INTERVENTION

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.

Interventions

Resin infiltration PROCEDURE

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.

Icon Group

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Dental caries and filling on anterior teeth.
• Dental anomaly on anterior teeth.
• Undergoing orthodontic treatment.
• Periodontal diseases.
• Cognitive and behavioural problems.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Gaziosmanpaşa University

Tokat Province, 60100, Turkey (Türkiye)

Location

Related Publications (28)

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• Altan H, Yilmaz RE. Clinical evaluation of resin infiltration treatment masking effect on hypomineralised enamel surfaces. BMC Oral Health. 2023 Jul 3;23(1):444. doi: 10.1186/s12903-023-03140-6.

  PMID: 37400849 DERIVED

MeSH Terms

Conditions

Molar Hypomineralization; Dental Enamel Hypoplasia

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Halenur Altan, assoc. prof.

  Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry

  STUDY DIRECTOR

• Rabia Erağca Yılmaz, Msc. Dt.

  Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 28, 2020
• Study Start: May 23, 2018
• Primary Completion: June 23, 2018
• Study Completion: December 20, 2019
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)