Resin Infiltration Treatment Versus a Combined Treatment With Microabrasion for the Management of MIH Affected Incisors

NCT04471571 | Unknown

• 1 other identifier: DShehab
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The prevalence of molar incisor hypomineralization is relatively high. It has been reported that MIH-affected children experience a wide range of negative impacts because of having visible enamel opacities on their incisors whether these teeth show post eruptive breakdown or not. The management of MIH is challenging with a broad spectrum of treatment modalities being available. However, there are no clear guidelines available to aid in clinical decision making. Possible treatment options for anterior teeth with MIH include: Microabrasion, resin infiltration, tooth bleaching, etch-bleach and seal technique and composite restorations or veneers. It is believed that these methods could be used alone or in a combination of methods to achieve better aesthetic results. For MIH affected-incisors microabrasion and resin infiltration are acceptable treatment options which could be used alone or in a combination. Accordingly, the aim of this study is to compare the clinical outcomes of using resin infiltration either alone or combined with microabrasion for the management of MIH affected incisors.

Conditions

Molar Incisor Hypomineralization

Outcome Measures

Primary Outcomes (1)

• Change in the aesthetics and amount of color masking of the lesion

  Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L\*, a\*, and b\* values will be recorded for each tooth based on the CIEL\*a\* b\* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=\[(∆L\*)2+(∆a\*)2+(∆b\*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.

  12 months

Secondary Outcomes (1)

• Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14

  12 months

Study Arms (2)

Resin infiltration group

ACTIVE COMPARATOR

Enamel lesions for this group will be treated only by resin infiltration.

Other: Resin infiltration for MIH-affected incisors

Microabrasion + resin infiltration group

EXPERIMENTAL

Enamel lesions for this group will be treated first by microabrasion followed by resin infiltration.

Other: Resin infiltration and microabrasion for MIH-affected incisors

Interventions

Resin infiltration and microabrasion for MIH-affected incisors OTHER

MIH-affected incisors will be treated with microabrasion followed by resin infiltration as a combined treatment

Microabrasion + resin infiltration group

Resin infiltration for MIH-affected incisors OTHER

MIH-affected incisors will be treated with resin infiltration alone

Resin infiltration group

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Cooperative children aged between 7-16 years old
• Children with MIH having enamel opacity involving at least one permanent incisor
• MIH- affected incisors which did not receive any previous treatment
• /3 of the crown should be visible in the oral cavity
• Lesions size should be more than 1mm
• Healthy children

You may not qualify if:

• Children with systemic diseases, allergies or any dental or facial anomaly other than MIH
• Children aged \< 7 or \> 16 years old
• Uncooperative children
• MIH patients without the affection of the incisors or with compromised incisor esthetics due to tooth surface loss, traumatic dental injury or caries
• MIH incisors which already received any kind of treatment
• Lesions which are smaller than 1mm in size

Sponsors & Collaborators

• Cairo University: lead

Related Publications (2)

• Almuallem Z, Busuttil-Naudi A. Molar incisor hypomineralisation (MIH) - an overview. Br Dent J. 2018 Oct 5. doi: 10.1038/sj.bdj.2018.814. Online ahead of print.

  PMID: 30287963 BACKGROUND

• Hasmun N, Lawson J, Vettore MV, Elcock C, Zaitoun H, Rodd H. Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment for Children with Molar Incisor Hypomineralisation: A Prospective Study. Dent J (Basel). 2018 Nov 1;6(4):61. doi: 10.3390/dj6040061.

  PMID: 30388743 BACKGROUND

MeSH Terms

Conditions

Molar Hypomineralization

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

• Shehab El-Din

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shehab El-Din

CONTACT

201066695543; dinanasrshehab@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Selection bias: will be overcome by randomization and allocation concealment. Performance bias: will be overcome by standardized method of application by single operator. Detection bias: will be overcome by blinding of the outcome assessor. Reporting bias: All the outcomes will be reported and published.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecurer

Model Details: two-arm parallel group randomized controlled trial

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 15, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share