Effect of Resin Infiltration on Hypersensitivity and Satisfaction in Children With Enamel Defects
The Role of Resin Infiltration Treatment on Dental Hypersensitivity and Patient-Parent Satisfaction in Children With Anterior Teeth Affected by Hypomineralization or Hypoplasia
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2025
CompletedFirst Submitted
Initial submission to the registry
August 5, 2025
CompletedFirst Posted
Study publicly available on registry
August 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2026
CompletedMarch 30, 2026
March 1, 2026
3 months
August 5, 2025
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Dental Hypersensitivity and Patient-Parent Satisfaction
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. 1. \- The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation. 2. \- The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head. 3. \- The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.
Baseline, 1 month, 3 months, and 6 months after treatment
Change in Dental Hypersensitivity and Patient-Parent Satisfaction
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. 1. \- The patient is aware of the stimulus but does not indicate discomfort and does not request discontinuation. 2. \- The patient responds to the stimulus with clear discomfort and requests discontinuation, either verbally or by turning the head. 3. \- The patient responds to the stimulus with pain and immediately and clearly requests discontinuation.
1 month, 3 months, and 6 months after treatment
Secondary Outcomes (1)
ral Health-Related Quality of Life, Esthetic Evaluation, Treatment Compliance
Baseline, 1 month, 3 months, and 6 months after treatment
Study Arms (1)
Resin Infiltration Treatment Group
OTHERAll participants receive resin infiltration treatment to anterior teeth affected by enamel defects.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gizem Tıraşçılead
Study Sites (1)
Inonu University
Malatya, Battalgazi, 44050, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sacide DUMAN, DDS
Inonu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
August 5, 2025
First Posted
August 12, 2025
Study Start
March 14, 2025
Primary Completion
June 14, 2025
Study Completion
January 13, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
The individual participant data (IPD) will not be shared due to patient confidentiality concerns and restrictions imposed by the informed consent forms. Additionally, the data contain sensitive personal health information, and sharing is limited to protect participant privacy in accordance with ethical guidelines and institutional policies.