Dental CariesNCT07393854
Clinical Success of Two Stainless Steel Crowns in Children Treated Under General Anesthesia
An observational study of Dental Caries and General Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the clinical performance and parental satisfaction of two commercially available stainless steel crown systems used in pediatric patients treated under general anesthesia. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Dental Caries, General Anesthesia, Pediatric Dentistry
- What is being tested?
- NuSmile Stainless Steel Crown and Kids Crown Stainless Steel Crown
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Jun 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: This study will include pediatric patients aged 2-8 years who have previously undergone stainless steel crown restorations under general anesthesia. Only patients with a minimum postoperative period of 6 months will be included. The study aims to evaluate clinical success and parental satisfaction regarding these restorations.
Who may be able to join
- Children aged 2-8 years
- Have received at least one stainless steel crown restoration under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry
- Have a minimum postoperative period of 6 months
- Parents provided written informed consent
Who cannot join
- Children whose parents did not provide written consent
- Children with chronic systemic diseases
- Children with physical or mental disabilities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University Faculty of Dentistry
Istanbul, Fatih, 34093
About this study
Official title: Clinical Success and Parental Satisfaction of Two Commercially Available Stainless Steel Crowns in Pediatric Patients Under General Anesthesia: A Comparative Study
The purpose of this study is to compare the clinical performance and parental satisfaction of two commercially available stainless steel crown systems used in pediatric patients treated under general anesthesia. Children aged 2-8 years who received at least one stainless steel crown under general anesthesia with a minimum follow-up period of 6 months will be evaluated.
Clinical outcomes will include crown retention, occlusal contact, gingival health, and other crown-related parameters assessed during follow-up examinations. Parental satisfaction regarding aesthetics, function, durability, and overall acceptance of the crowns will be assessed using a structured questionnaire.
Read the detailed description
This observational clinical study is designed to compare the clinical performance and parental satisfaction of two commercially available stainless steel crown systems (NuSmile and Kids Crown) placed in pediatric patients treated under general anesthesia.
The study population consists of children aged 2-8 years who received at least one stainless steel crown under general anesthesia at the Department of Pediatric Dentistry, Bezmialem Vakıf University, within the previous three years. Only restorations with a minimum postoperative follow-up of 6 months will be evaluated. All clinical examinations will be completed during a defined 1-month assessment period.
Clinical evaluations will be performed by a single calibrated examiner to ensure consistency and reduce inter-examiner variability. Examinations will be conducted under standardized dental light conditions using a dental mirror and curved explorer. A structured and previously validated scoring system adapted from the literature will be applied for all clinical assessments.
The clinical evaluation will focus on crown-related outcomes, including retention, occlusal contact, proximal contact adaptation, crown integrity, gingival response, and oral hygiene status. Additional clinical signs such as pain, swelling, fistula formation, percussion sensitivity, and tooth mobility will also be recorded to identify potential biological or functional complications associated with the restorations.
Parental satisfaction will be assessed using a structured questionnaire administered to parents or legal guardians at the follow-up visit. Satisfaction will be evaluated using a 5-point Likert scale addressing aesthetic appearance, functional performance, durability, and overall acceptance of the stainless steel crowns.
Statistical analyses will be conducted to compare clinical outcomes and parental satisfaction between the two crown systems. Appropriate statistical tests will be selected based on data distribution and variable characteristics, with statistical significance set according to conventional thresholds.
- Conditions
- Dental Caries, General Anesthesia, Pediatric Dentistry
- Being tested
- NuSmile Stainless Steel Crown, Kids Crown Stainless Steel Crown
- Keywords
- steenless steel crown, pediatric dental treatments, general anesthesia, restorative dental treatments
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuSmile Stainless Steel CrownDevice
NuSmile stainless steel crowns were placed as part of routine pediatric dental treatment under general anesthesia. The crowns were placed at least 6 months prior to study evaluation. No intervention is applied during the study period; outcomes are assessed retrospectively at follow-up.
Kids Crown Stainless Steel CrownDevice
Kids Crown stainless steel crowns were placed as part of routine pediatric dental treatment under general anesthesia. The crowns were placed at least 6 months prior to study evaluation. No intervention is applied during the study period; outcomes are assessed retrospectively at follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Nu Smile Group | This group consists of pediatric patients aged 2-8 years who have received Nu Smile stainless steel crowns under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry. Participants have a minimum postoperative period of 6 months and will be evaluated based on clinical success and parental satisfaction. Receives: Device: NuSmile Stainless Steel Crown | |
| Kids Crown Group | This group consists of pediatric patients aged 2-8 years who have received Kids Crown stainless steel crowns under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry. Participants have a minimum postoperative period of 6 months and will be evaluated based on clinical success and parental satisfaction. Receives: Device: Kids Crown Stainless Steel Crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Clinical Success of Stainless Steel Crowns (Composite Outcome)
Overall clinical success will be defined as the presence of a clinically acceptable stainless steel crown at follow-up, based on a composite assessment of predefined clinical parameters. A crown will be considered clinically successful only if all criteria listed below are met.
Clinical success criteria include:
Crown retention (present) Occlusal contact (present) Proximal contact adaptation (acceptable) Absence of crown perforation Absence of pain or swelling Absence of fistula formation Absence of tenderness to percussion Absence of pathological tooth mobility Gingival health score ≤1 on the Gingival Index
Unit of Measure:
Binary outcome (Successful / Unsuccessful)
Measured: 1 month (single follow-up assessment for all participants with a minimum of 6 months postoperative period)
Secondary outcomes (2)
Gingival Health Around Stainless Steel Crowns
Gingival health will be assessed using the Gingival Index (Löe and Silness) to evaluate inflammation of the gingival tissues adjacent to the crowns.
Scale:
Gingival Index (GI):
0 = Normal gingiva
- = Mild inflammation
- = Moderate inflammation
- = Severe inflammation Higher scores indicate worse gingival health.
Measured: 1 month (single clinical assessment at follow-up visit)
Parental Satisfaction with Stainless Steel Crowns
Parental satisfaction will be assessed using a structured questionnaire based on a 5-point Likert scale, evaluating parental perception of the stainless steel crowns.
Domains assessed include:
Aesthetic satisfaction (color, appearance, shape, size) Functional satisfaction (durability, retention, comfort) Overall acceptance and parental preference
Scale:
5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) Higher scores indicate greater parental satisfaction.
Measured: 1 month (single questionnaire-based assessment at follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Jun 2025
- Primary completion15 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narmin Mammadli, Bezmialem Vakif University
- Investigators
- Başak Günay, DDS, Study director, Bezmialem Vakıf University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393854
- Sponsor's protocol ID
- 08.06.2023-E.110543
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy concerns and ethical considerations related to patient confidentiality.
Publications
Gunay B, Soylu N, Bayram M. Clinical outcomes and parental satisfaction of two stainless steel crown systems in pediatric patients: a retrospective observational cohort study. BMC Oral Health. 2026 Jun 23;26(1):1191. doi: 10.1186/s12903-026-08998-w.
PubMed 42332667
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Success and Parental Satisfaction of Two Commercially Available Stainless Steel Crowns in Pediatric Patients Under General Anesthesia: A Comparative Study
- ClinicalTrials.gov ID
- NCT07393854
- Acronym / sponsor ID
- 08.06.2023-E.110543
- Conditions
- Dental Caries, General Anesthesia, Pediatric Dentistry
- Keywords
- steenless steel crown, pediatric dental treatments, general anesthesia, restorative dental treatments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical performance and parental satisfaction of two commercially available stainless steel crown systems used in pediatric patients treated under general anesthesia. Children aged 2-8 years who received at least one stainless steel crown under general anesthesia with a minimum follow-up period of 6 months will be evaluated.
Clinical outcomes will include crown retention, occlusal contact, gingival health, and other crown-related parameters assessed during follow-up examinations. Parental satisfaction regarding aesthetics, function, durability, and overall acceptance of the crowns will be assessed using a structured questionnaire.
Detailed description
This observational clinical study is designed to compare the clinical performance and parental satisfaction of two commercially available stainless steel crown systems (NuSmile and Kids Crown) placed in pediatric patients treated under general anesthesia.
The study population consists of children aged 2-8 years who received at least one stainless steel crown under general anesthesia at the Department of Pediatric Dentistry, Bezmialem Vakıf University, within the previous three years. Only restorations with a minimum postoperative follow-up of 6 months will be evaluated. All clinical examinations will be completed during a defined 1-month assessment period.
Clinical evaluations will be performed by a single calibrated examiner to ensure consistency and reduce inter-examiner variability. Examinations will be conducted under standardized dental light conditions using a dental mirror and curved explorer. A structured and previously validated scoring system adapted from the literature will be applied for all clinical assessments.
The clinical evaluation will focus on crown-related outcomes, including retention, occlusal contact, proximal contact adaptation, crown integrity, gingival response, and oral hygiene status. Additional clinical signs such as pain, swelling, fistula formation, percussion sensitivity, and tooth mobility will also be recorded to identify potential biological or functional complications associated with the restorations.
Parental satisfaction will be assessed using a structured questionnaire administered to parents or legal guardians at the follow-up visit. Satisfaction will be evaluated using a 5-point Likert scale addressing aesthetic appearance, functional performance, durability, and overall acceptance of the stainless steel crowns.
Statistical analyses will be conducted to compare clinical outcomes and parental satisfaction between the two crown systems. Appropriate statistical tests will be selected based on data distribution and variable characteristics, with statistical significance set according to conventional thresholds.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nu Smile Group | – | Device: NuSmile Stainless Steel CrownThis group consists of pediatric patients aged 2-8 years who have received Nu Smile stainless steel crowns under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry. Participants have a minimum postoperative period of 6 months and will be evaluated based on clinical success and parental satisfaction. |
| Kids Crown Group | – | Device: Kids Crown Stainless Steel CrownThis group consists of pediatric patients aged 2-8 years who have received Kids Crown stainless steel crowns under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry. Participants have a minimum postoperative period of 6 months and will be evaluated based on clinical success and parental satisfaction. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study will include pediatric patients aged 2-8 years who have previously undergone stainless steel crown restorations under general anesthesia. Only patients with a minimum postoperative period of 6 months will be included. The study aims to evaluate clinical success and parental satisfaction regarding these restorations.
Key inclusion criteria (4 listed)
- Children aged 2-8 years
- Have received at least one stainless steel crown restoration under general anesthesia at Bezmialem Vakıf University Faculty of Dentistry
- Have a minimum postoperative period of 6 months
- Parents provided written informed consent
Key exclusion criteria (3 listed)
- Children whose parents did not provide written consent
- Children with chronic systemic diseases
- Children with physical or mental disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuSmile Stainless Steel CrownNuSmile stainless steel crowns were placed as part of routine pediatric dental treatment under general anesthesia. The crowns were placed at least 6 months prior to study evaluation. No intervention is applied during the study period; outcomes are assessed retrospectively at follow-up. | Device | Nu Smile Group |
| Kids Crown Stainless Steel CrownKids Crown stainless steel crowns were placed as part of routine pediatric dental treatment under general anesthesia. The crowns were placed at least 6 months prior to study evaluation. No intervention is applied during the study period; outcomes are assessed retrospectively at follow-up. | Device | Kids Crown Group |
Primary outcome
Overall Clinical Success of Stainless Steel Crowns (Composite Outcome)
Time frame: 1 month (single follow-up assessment for all participants with a minimum of 6 months postoperative period)
Overall clinical success will be defined as the presence of a clinically acceptable stainless steel crown at follow-up, based on a composite assessment of predefined clinical parameters. A crown will be considered clinically successful only if all criteria listed below are met. Clinical success criteria include: Crown retention (present) Occlusal contact (present) Proximal contact adaptation (acceptable) Absence of crown perforation Absence of pain or swelling Absence of fistula formation Absence of tenderness to percussion Absence of pathological tooth mobility Gingival health score ≤1 on the Gingival Index Unit of Measure: Binary outcome (Successful / Unsuccessful)
2 secondary outcomes
Gingival Health Around Stainless Steel Crowns
Time frame: 1 month (single clinical assessment at follow-up visit)
Parental Satisfaction with Stainless Steel Crowns
Time frame: 1 month (single questionnaire-based assessment at follow-up visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 42332667Gunay B, Soylu N, Bayram M. Clinical outcomes and parental satisfaction of two stainless steel crown systems in pediatric patients: a retrospective observational cohort study. BMC Oral Health. 2026 Jun 23;26(1):1191. doi: 10.1186/s12903-026-08998-w.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy concerns and ethical considerations related to patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Başak Günay, DDS study director
Bezmialem Vakıf University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries and General Anesthesia, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Clinical Success of Stainless Steel Crowns (Composite Outcome) (time frame: 1 month (single follow-up assessment for all participants with a minimum of 6 months postoperative period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07393854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.