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NCT Number: NCT07118111

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

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.

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Key information

Conditions

Molar Incisor Hypomineralisation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Dental Enamel Hypoplasia Dental Hypersensitivity Developmental Defects of Enamel Enamel Hypoplasia Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Battalgazi, 44050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resin infiltration

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.

Primary outcomes

  1. Change in Dental Hypersensitivity and Patient-Parent Satisfaction

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

    Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment.

    Schiff Cold Air Sensitivity Scale (SCASS):

    0 - The patient does not respond to the air stimulus.

    • - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation.
    • - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head.
    • - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.

  2. Change in Dental Hypersensitivity and Patient-Parent Satisfaction

    Time frame: 1 month, 3 months, and 6 months after treatment

    Dental hypersensitivity will be assessed using the Schiff Cold Air Sensitivity Scale (SCASS) before treatment and at 1, 3, and 6 months post-treatment, where higher scores indicate greater sensitivity. Patient and parent satisfaction regarding esthetic and functional outcomes will be measured through standardized questionnaires administered after treatment.

    Schiff Cold Air Sensitivity Scale (SCASS):

    0 - The patient does not respond to the air stimulus.

    • - The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation.
    • - The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head.
    • - The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.

Secondary outcomes

  1. ral Health-Related Quality of Life, Esthetic Evaluation, Treatment Compliance

    Time frame: Baseline, 1 month, 3 months, and 6 months after treatment

    Oral health-related quality of life (OHRQoL) will be measured using the Pediatric Oral Health-Related Quality of Life (POQL) scale completed by both children and their parents before treatment and at follow-up visits. POQL scores will be calculated on a 0-100 scale, with higher scores indicating a lower quality of life. Esthetic changes will be assessed via clinical evaluations and patient/parent satisfaction surveys. Treatment compliance and acceptability will be recorded during the intervention process. Any adverse effects or complications following resin infiltration treatment will be monitored and documented throughout the study period.

Sponsors and collaborators

Lead sponsor

Gizem Tıraşçı

Other

Registry information

Official study title

The Role of Resin Infiltration Treatment on Dental Hypersensitivity and Patient-Parent Satisfaction in Children With Anterior Teeth Affected by Hypomineralization or Hypoplasia

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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