Effect of Resin Infiltration on Hypersensitivity and Satisfaction in Children With Enamel Defects

NCT ID: NCT07118111

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-14

Study Completion Date

2025-11-15

Brief Summary

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This study evaluates the effect of resin infiltration on dental sensitivity, quality of life, and satisfaction in children aged 7-14 with enamel defects in their front teeth. Forty children received treatment, and outcomes were measured through sensitivity tests and questionnaires for both children and parents.

Detailed Description

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Developmental enamel defects can negatively impact oral health-related quality of life by causing esthetic concerns and dental hypersensitivity in children. This prospective clinical study included 40 children aged 7-14 years diagnosed with hypomineralization or hypoplasia in their anterior teeth. All participants received resin infiltration treatment. Dental hypersensitivity was evaluated pre- and post-treatment using the Schiff Cold Air Sensitivity Scale (SCASS). Oral health-related quality of life was assessed using the Pediatric Oral Health-Related Quality of Life (POQL) scale through both child and parent forms. Post-treatment esthetic satisfaction levels were recorded based on reports from both children and their parents. The study aimed to determine the impact of resin infiltration on improving sensitivity, quality of life, and satisfaction in this population.

Conditions

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Molar Incisor Hypomineralisation Enamel Hypoplasia Dental Hypersensitivity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single group interventional study where all participants receive resin infiltration treatment. There is no comparison or control group. Outcomes such as dental hypersensitivity and patient satisfaction will be measured before and after treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resin Infiltration Treatment Group

All participants receive resin infiltration treatment to anterior teeth affected by enamel defects.

Group Type OTHER

Resin infiltration

Intervention Type PROCEDURE

Application of a low-viscosity resin infiltrant to the anterior teeth affected by enamel defects. This procedure aims to reduce dental hypersensitivity and improve esthetic appearance.

Interventions

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Resin infiltration

Application of a low-viscosity resin infiltrant to the anterior teeth affected by enamel defects. This procedure aims to reduce dental hypersensitivity and improve esthetic appearance.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children aged between 7 and 14 years.
* Children in good general health without any systemic disease.
* Presence of at least one anterior permanent tooth with hypomineralization or hypoplasia.
* Teeth with lesions larger than 1 mm that are suitable for resin infiltration treatment.
* Voluntary participation of both the child and their parent/guardian in the study, with signed informed consent.

Exclusion Criteria

* Children with systemic diseases or undergoing medical treatment.
* Cases with active caries, trauma, restorations, or endodontic treatment applied or required on anterior teeth.
* Individuals who have previously received resin infiltration or similar treatment on the same tooth.
* Children with a history of allergies or sensitivity to the materials used in the procedure.
* Individuals who have received interventions such as fluoride varnish, fissure sealants, or tooth whitening on their teeth.
* Children who do not possess the cognitive ability to understand and respond to the questionnaire or sensitivity assessment.
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gizem Tıraşçı

OTHER

Sponsor Role lead

Responsible Party

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Gizem Tıraşçı

Research Assistant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sacide DUMAN, DDS

Role: STUDY_DIRECTOR

Inonu University

Locations

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Inonu University

Malatya, Battalgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2025/7696

Identifier Type: -

Identifier Source: org_study_id

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