Dental Restoration FailureNCT07375706
Operator Experience and Restorative Clinical Performance of Posterior Composite Restorations
An observational study of Dental Restoration Failure, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Dental Restoration Failure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2024to 17 Feb 2025
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, Fatih, 34093
About this study
Official title: Clinical Performance of Posterior Resin Composite Restorations Placed by Undergraduate Students and Postgraduate Trainees: A Retrospective Study Using USPHS and FDI Criteria
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.
Read the detailed description
This retrospective observational study was conducted at the Department of Pediatric Dentistry of a university-based dental faculty to compare the clinical performance of posterior resin composite restorations placed by undergraduate dental students and postgraduate specialty trainees.
Dental records of pediatric patients aged 6 to 13 years who received posterior resin composite restorations on primary or permanent first and second molars were retrospectively reviewed. A total of 200 restorations were included in the study, of which 100 were placed by undergraduate students and 100 by postgraduate trainees. All restorations were placed using the same microhybrid resin composite material as part of routine clinical care.
Restorations were excluded if they were placed by operators outside the defined study groups, if materials other than resin composite were used, if follow-up duration was less than three months, or if the restorations were placed on teeth other than posterior molars. Clinical evaluations were performed during routine follow-up or concurrent dental treatment visits.
All restorations were assessed by a blinded examiner using two standardized evaluation systems: the modified United States Public Health Service (USPHS-Ryge) criteria and the FDI World Dental Federation (FDI-Hickel) criteria. Esthetic, functional, and biological parameters were evaluated clinically, and radiographic assessments were performed when clinically indicated. Under the USPHS criteria, restorations were categorized as acceptable or unacceptable. According to the FDI criteria, scores of 1-2 were considered successful, score 3 clinically acceptable, and scores of 4-5 unsuccessful.
Recorded variables included operator group, restoration type (one-, two-, or three-surface), follow-up duration, tooth type (primary or permanent), patient age, and endodontic treatment history. Clinical outcomes were compared between operator groups and across follow-up intervals to evaluate the influence of operator experience and time on restoration performance.
Statistical analyses were performed using appropriate non-parametric tests due to non-normal data distribution. Descriptive statistics were used to summarize the data, and group comparisons were conducted with a significance level set at p < 0.05.
The results of this study aim to clarify the role of operator experience in the long-term success of posterior resin composite restorations in pediatric patients and to contribute to evidence-based improvements in undergraduate and postgraduate dental training programs.
- Conditions
- Dental Restoration Failure
- Keywords
- Pediatric Dentistry, USPHS Criteria, FDI Criteria, Operator Experience, Dental Restoration Longevity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (-).
Measured: 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.
Measured: Up to 24 months
Secondary outcomes (2)
Comparison of Clinical Performance Between Undergraduate and Postgraduate Operators Using USPHS Criteria
Clinical performance outcomes assessed by the modified USPHS-Ryge criteria were compared between undergraduate dental students and postgraduate specialty trainees across follow-up periods.
Measured: Up to 24 month
Comparison of Clinical Performance Between Undergraduate and Postgraduate Operators Using FDI Criteria
Clinical performance outcomes assessed by the FDI World Dental Federation criteria were compared between undergraduate dental students and postgraduate specialty trainees across follow-up periods.
Measured: Up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start3 Jun 2024
- Primary completion23 Jan 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration FailureStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narmin Mammadli, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375706
- Sponsor's protocol ID
- 08.07.2024-E.157036
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Posterior Resin Composite Restorations Placed by Undergraduate Students and Postgraduate Trainees: A Retrospective Study Using USPHS and FDI Criteria
- ClinicalTrials.gov ID
- NCT07375706
- Acronym / sponsor ID
- 08.07.2024-E.157036
- Conditions
- Dental Restoration Failure
- Keywords
- Pediatric Dentistry, USPHS Criteria, FDI Criteria, Operator Experience, Dental Restoration Longevity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 29 Jan 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.
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.
Detailed description
This retrospective observational study was conducted at the Department of Pediatric Dentistry of a university-based dental faculty to compare the clinical performance of posterior resin composite restorations placed by undergraduate dental students and postgraduate specialty trainees.
Dental records of pediatric patients aged 6 to 13 years who received posterior resin composite restorations on primary or permanent first and second molars were retrospectively reviewed. A total of 200 restorations were included in the study, of which 100 were placed by undergraduate students and 100 by postgraduate trainees. All restorations were placed using the same microhybrid resin composite material as part of routine clinical care.
Restorations were excluded if they were placed by operators outside the defined study groups, if materials other than resin composite were used, if follow-up duration was less than three months, or if the restorations were placed on teeth other than posterior molars. Clinical evaluations were performed during routine follow-up or concurrent dental treatment visits.
All restorations were assessed by a blinded examiner using two standardized evaluation systems: the modified United States Public Health Service (USPHS-Ryge) criteria and the FDI World Dental Federation (FDI-Hickel) criteria. Esthetic, functional, and biological parameters were evaluated clinically, and radiographic assessments were performed when clinically indicated. Under the USPHS criteria, restorations were categorized as acceptable or unacceptable. According to the FDI criteria, scores of 1-2 were considered successful, score 3 clinically acceptable, and scores of 4-5 unsuccessful.
Recorded variables included operator group, restoration type (one-, two-, or three-surface), follow-up duration, tooth type (primary or permanent), patient age, and endodontic treatment history. Clinical outcomes were compared between operator groups and across follow-up intervals to evaluate the influence of operator experience and time on restoration performance.
Statistical analyses were performed using appropriate non-parametric tests due to non-normal data distribution. Descriptive statistics were used to summarize the data, and group comparisons were conducted with a significance level set at p < 0.05.
The results of this study aim to clarify the role of operator experience in the long-term success of posterior resin composite restorations in pediatric patients and to contribute to evidence-based improvements in undergraduate and postgraduate dental training programs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Performance of Posterior Resin Composite Restorations Assessed by Modified USPHS-Ryge Criteria
Time frame: Up to 24 months
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 (-).
Clinical Performance of Posterior Resin Composite Restorations Assessed by FDI World Dental Federation Criteria
Time frame: Up to 24 months
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.
2 secondary outcomes
Comparison of Clinical Performance Between Undergraduate and Postgraduate Operators Using USPHS Criteria
Time frame: Up to 24 month
Comparison of Clinical Performance Between Undergraduate and Postgraduate Operators Using FDI Criteria
Time frame: Up to 24 month
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 29 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Restoration Failure, 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 5 inclusion and 5 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 29 Jan 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?
Clinical Performance of Posterior Resin Composite Restorations Assessed by Modified USPHS-Ryge Criteria (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.