NCT07375706

Brief Summary

This retrospective observational study aimed to evaluate the long-term clinical performance of posterior resin composite restorations placed by undergraduate dental students and postgraduate specialty trainees in pediatric patients. Dental records of children aged 6 to 13 years who received posterior composite restorations at a university-based pediatric dentistry clinic were reviewed. A total of 200 restorations placed on primary and permanent molars were clinically evaluated during routine follow-up visits using standardized assessment systems. The modified United States Public Health Service (USPHS) criteria and the FDI World Dental Federation criteria were used to assess esthetic, functional, and biological outcomes. Evaluations were performed by a blinded examiner, and radiographic assessments were conducted when clinically indicated. Clinical outcomes were compared between operator groups according to training level, follow-up duration, restoration type, tooth type, and endodontic treatment history. The findings of this study aim to provide insight into the impact of operator experience on the clinical success and longevity of posterior resin composite restorations in pediatric dentistry and to support evidence-based improvements in undergraduate and postgraduate dental education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 13, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

Pediatric DentistryUSPHS CriteriaFDI CriteriaOperator ExperienceDental Restoration Longevity

Outcome Measures

Primary Outcomes (2)

  • Clinical Performance of Posterior Resin Composite Restorations Assessed by Modified USPHS-Ryge Criteria

    The clinical performance of posterior resin composite restorations was evaluated using the modified United States Public Health Service (USPHS-Ryge) criteria. Based on esthetic, functional, and biological parameters, restorations were categorized into two groups according to clinical acceptability: acceptable (+) and unacceptable (-).

    Up to 24 months

  • Clinical Performance of Posterior Resin Composite Restorations Assessed by FDI World Dental Federation Criteria

    The clinical performance of posterior resin composite restorations was evaluated using the FDI World Dental Federation (Hickel) criteria, based on esthetic, functional, and biological parameters. Restorations were scored on a 5-point ordinal scale ranging from 1 to 5, where scores of 1 and 2 were considered successful, score 3 clinically acceptable, and scores of 4 and 5 unsuccessful. Higher scores indicate worse clinical performance.

    Up to 24 months

Secondary Outcomes (2)

  • Comparison of Clinical Performance Between Undergraduate and Postgraduate Operators Using USPHS Criteria

    Up to 24 month

  • Comparison of Clinical Performance Between Undergraduate and Postgraduate Operators Using FDI Criteria

    Up to 24 month

Study Arms (2)

Undergraduate Operators

Posterior resin composite restorations placed by undergraduate dental students as part of routine clinical training in the Department of Pediatric Dentistry. All restorations were performed under faculty supervision and evaluated retrospectively using standardized clinical assessment criteria.

Postgraduate Operators

Posterior resin composite restorations placed by postgraduate specialty trainees in pediatric dentistry during routine clinical care. Restorations were retrospectively evaluated using the same clinical assessment protocols as the undergraduate group.

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of children aged 6 to 13 years who received posterior resin composite restorations on primary or permanent molar teeth at a university-based pediatric dentistry clinic. All included restorations were placed by undergraduate dental students or postgraduate specialty trainees as part of routine clinical care. Patients were identified retrospectively through institutional dental records, and only cases with sufficient clinical documentation and a minimum follow-up period of three months were included for evaluation.

You may qualify if:

  • Children aged 6 to 13 years at the time of treatment
  • Patients who received posterior resin composite restorations on primary or permanent first or second molars
  • Restorations placed by undergraduate dental students or postgraduate specialty trainees in the Department of Pediatric Dentistry
  • Restorations with a minimum follow-up period of 3 months
  • Availability of complete clinical records allowing retrospective evaluation

You may not qualify if:

  • Restorations placed by clinicians outside the undergraduate or postgraduate trainee groups
  • Restorations performed using materials other than resin composite
  • Restorations placed on teeth other than posterior molars
  • Restorations with a follow-up duration shorter than 3 months
  • Incomplete or missing clinical records preventing standardized evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, Specialist in Pediatric Dentistry

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 29, 2026

Study Start

June 3, 2024

Primary Completion

January 23, 2025

Study Completion

February 17, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because this study is a retrospective observational study involving pediatric patients, and data use is restricted by ethical approval and institutional policies. In addition, informed consent for data sharing beyond the scope of the original study was not obtained, and all analyses were conducted using anonymized clinical records.

Locations