NCT07118111

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

August 5, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

resin infiltrationhypomineralizationhypoplasiadental sensitivity

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

OTHER

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

Procedure: Resin infiltration

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.

Resin Infiltration Treatment Group

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Study Sites (1)

Inonu University

Malatya, Battalgazi, 44050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Molar HypomineralizationDental Enamel Hypoplasia

Condition Hierarchy (Ancestors)

Dental Enamel HypomineralizationDevelopmental Defects of EnamelTooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sacide DUMAN, DDS

    Inonu University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
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.

Locations