Clinical Evaluation of Resin Infiltration Treatment of MIH-affected Teeth in Pediatric Patients

NCT07469124 | Active Not Recruiting

• 1 other identifier: BAP-4123
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine the clinical success of different pre-treatments in resin infiltration therapy applied to the incisors of pediatric patients with Molar Incisor Hypomineralization (MIH) and to evaluate the impact of treatment on the quality of life of children. The main questions that this study aims to answer are:

• Does resin infiltration therapy improve the color and surface appearance of incisors affected by MIH?
• Is there a reduction in tooth sensitivity after treatment?
• Are patients and their parents satisfied with the treatment results?
• Is there an improvement in the quality of life of children after treatment? Researchers will apply resin infiltration therapy to incisors affected by MIH and evaluate the results over a 12-month follow-up period. Participants will:
• Receive resin infiltration therapy on their MIH incisors.
• Attend follow-up appointments at 1, 3, 6, 9, and 12 months.
• At the follow-up appointments, the teeth will be evaluated with clinical examination and photographs.
• Participants will complete questionnaires regarding tooth sensitivity and quality of life related to oral health. The results of this study are expected to contribute to the development of minimally invasive treatment options for children with MIH.

Conditions

Molar Incisor Hypomineralization

Keywords

Resin Infiltration; Molar Incisor hypomineralization; Pediatric Dentistry; Enamel Defects; Dental Hypersensitivity; Minimally Invasive Treatment; Clinical Follow-Up; Oral Health Related Quality of Life; Enamel Microabrasion; Air abrasion; Combined Treatment

Outcome Measures

Primary Outcomes (1)

• Change in Lesion Color and Clinical Appearance

  Color change of hypomineralized enamel lesions will be objectively evaluated using a dental spectrophotometer. Color differences between baseline and follow-up measurements will be recorded to assess treatment effectiveness.

  Baseline, 1 month, 3 months, 6 months, 9 months and 12 months

Secondary Outcomes (4)

• Change in Tooth Sensitivity (Visual Analog Scale)

  Baseline, 1 month, 3 months, 6 months, 9 months and 12 months

• Change in Tooth Sensitivity (Schiff Cold Air Sensitivity Scale)

  Baseline, 1 month, 3 months, 6 months, 9 months, and 12 months

• Change in Oral Health-Related Quality of Life (COHIP-SF-19)

  Baseline, 3 months and 6 months

• Change in Oral Health-Related Quality of Life (Parental-Caregiver Perceptions Questionnaire)

  Baseline, 3 months, and 6 months

Study Arms (6)

Creamy/white colored lesions - Resin Infıltration

EXPERIMENTAL

Procedure: Resin Infiltration

Creamy/white colored lesions - Microabrasion+Resin Infıltration

EXPERIMENTAL

Procedure: Microabrasion Followed by Resin Infiltration

Creamy/white colored lesions - Air abrasion+Resin Infıltration

EXPERIMENTAL

Procedure: Air Abrasion Followed by Resin Infiltration

Yellow/brown colored lesions - Resin Infiltration

EXPERIMENTAL

Procedure: Resin Infiltration

Yellow/brown colored lesions - Microabrasion+Resin Infiltration

EXPERIMENTAL

Procedure: Microabrasion Followed by Resin Infiltration

Yellow/brown colored lesions - Air abrasion+Resin Infiltration

EXPERIMENTAL

Procedure: Air Abrasion Followed by Resin Infiltration

Interventions

Resin Infiltration PROCEDURE

A minimally invasive treatment in which a low-viscosity resin material is applied to porous enamel lesions to reduce opacity, improve clinical appearance, and stabilize the enamel surface.

Creamy/white colored lesions - Resin Infıltration; Yellow/brown colored lesions - Resin Infiltration

Microabrasion Followed by Resin Infiltration PROCEDURE

A combined treatment protocol involving enamel microabrasion prior to resin infiltration to evaluate its effect on treatment efficacy, lesion appearance, and clinical outcomes in hypomineralized enamel lesions.

Creamy/white colored lesions - Microabrasion+Resin Infıltration; Yellow/brown colored lesions - Microabrasion+Resin Infiltration

Air Abrasion Followed by Resin Infiltration PROCEDURE

A combined minimally invasive treatment in which air abrasion is used for enamel surface preparation prior to resin infiltration to optimize resin penetration and improve esthetic and clinical outcomes in hypomineralized lesions.

Creamy/white colored lesions - Air abrasion+Resin Infıltration; Yellow/brown colored lesions - Air abrasion+Resin Infiltration

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child must be between 6 and 14 years old,
• Diagnosed with molar incisor hypomineralization (according to EAPD criteria) and have lesions in the incisors,
• The tooth to be treated must not be cavitated or must not require restoration,
• Having the reading and writing skills to answer the scale,
• Having no communication impairments (auditory, visual, cognitive),
• Having no systemic illnesses that would affect oral health,
• Not taking any medications that would affect oral health,
• Both the child and their parents must be willing to complete the scale,
• Agree to attend the 12-month follow-up appointments.

You may not qualify if:

• Presence of enamel defects other than MIH in the target tooth, such as dental fluorosis, amelogenesis imperfecta, or enamel hypoplasia;
• Presence of significant caries, extensive dentin caries, large restorations, fissure sealants, composite restorations, or any existing restoration that may interfere with lesion evaluation in the affected tooth;
• Presence of spontaneous pain, abscess/fistula, suspected pulpitis, or need for endodontic treatment in the affected tooth;
• Presence of orthodontic appliances (e.g., brackets or bands) on the tooth to be evaluated that may interfere with color measurement;
• Known allergy or hypersensitivity to the dental materials used in the study;
• History of recent microabrasion, bleaching, resin infiltration, or similar procedures performed on the affected tooth;
• Inability of the participant to read and write sufficiently to complete the questionnaire;
• Presence of any systemic disease that may affect oral health;
• Use of medications that may affect oral health;
• Presence of any communication barriers (hearing, visual, or cognitive impairment) that may interfere with study participation;
• Refusal or unwillingness of either the participant or the parent/guardian to complete the questionnaire.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

İnönü University Faculty of Dentistry

Malatya, Battalgazi, 44320, Turkey (Türkiye)

Location

Related Publications (4)

• Hoan NQ, Huyen NP, Son DC, Thien DH, Sabet CJ, Ngoc VTN. Effectiveness of resin infiltration in the management of anterior teeth affected by molar incisor hypomineralisation (MIH): A systematic review and meta-analysis. J Dent. 2024 Oct;149:105254. doi: 10.1016/j.jdent.2024.105254. Epub 2024 Jul 26.

  PMID: 39067648 BACKGROUND

• Jawdekar AM, Kamath S, Kale S, Mistry L. Assessment of oral health-related quality of life (OHRQoL) in children with molar incisor hypomineralization (MIH) - A systematic review and meta-analysis of observational studies. J Indian Soc Pedod Prev Dent. 2022 Oct-Dec;40(4):368-376. doi: 10.4103/jisppd.jisppd_27_23.

  PMID: 36861552 BACKGROUND

• Amend S, Stork S, Lucker S, Seipp A, Gartner U, Frankenberger R, Kramer N. Influence of different pre-treatments on the resin infiltration depth into enamel of teeth affected by molar-incisor hypomineralization (MIH). Dent Mater. 2024 Jul;40(7):1015-1024. doi: 10.1016/j.dental.2024.05.010. Epub 2024 May 13.

  PMID: 38744567 BACKGROUND

• Hasmun N, Vettore MV, Lawson JA, Elcock C, Zaitoun H, Rodd HD. Determinants of children's oral health-related quality of life following aesthetic treatment of enamel opacities. J Dent. 2020 Jul;98:103372. doi: 10.1016/j.jdent.2020.103372. Epub 2020 May 11.

  PMID: 32437856 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

• Zekiye Şeyma Gümüşboğa, Assistant Professor

  Inonu University

  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: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 13, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-02

Locations

TU (1)