Clinical TrialNCT07081529
Clinical Evaluation of Class I Direct and Indirect Restorations Over 10 Years
A study testing Direct Restoration with Microhybrid Composite and Indirect Restoration with Reinforced Microfill Composite in people with Clinical Trial and Dental Caries, run by Kocaeli University.
Trial summary
This clinical study aims to evaluate and compare the long-term clinical performance of direct and indirect restorations in Class I cavities of molar teeth over a 10-year period. A total of 54 restorations (27 direct and 27 indirect) were placed in 27 patients, with each patient receiving one direct and one indirect… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial, Dental Caries
- What is being tested?
- Direct Restoration with Microhybrid Composite and Indirect Restoration with Reinforced Microfill Composite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jun 2024
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting with two Class I cavities
- Good oral hygiene maintenance
- Absence of pulp or periodontal disease
- Requirement for restoration of permanent molars due to occlusal caries
Who cannot join
- Presence of parafunctional habits (e.g., bruxism or clenching)
- Poor oral hygiene
- Lack of interest in or refusal to comply with oral hygiene instructions
- Pulp exposure during caries removal
- Percussion sensitivity indicating possible pulpal or periapical pathology
- Spontaneous discomfort associated with periodontal disease
About this study
Official title: Clinical Evaluation of Direct and Indirect Restorations in Class I Cavities: A 10-Year Follow-up Study
This clinical study aims to evaluate and compare the long-term clinical performance of direct and indirect restorations in Class I cavities of molar teeth over a 10-year period. A total of 54 restorations (27 direct and 27 indirect) were placed in 27 patients, with each patient receiving one direct and one indirect restoration. The restorations were evaluated at baseline, and at 1-, 2-, and 10-year follow-ups using modified USPHS criteria.
Read the detailed description
This prospective clinical study was designed to evaluate and compare the long-term clinical performance of direct and indirect composite restorations in Class I cavities of permanent molar teeth over a 10-year period.
A total of 27 patients were enrolled in the study. Each participant received one direct and one indirect restoration, resulting in a total of 54 restorations (27 direct and 27 indirect).
Direct restorations were performed intraorally using a microhybrid composite and adhesive system in accordance with the manufacturer's instructions. Indirect restorations were fabricated in the laboratory using a reinforced microfill composite system and cemented using resin cement.
All restorations were clinically evaluated at baseline, and at 1-, 2-, and 10-year follow-up appointments. The modified United States Public Health Service (USPHS) criteria were used for evaluation. The assessed parameters included surface texture, anatomic form, color match, marginal adaptation, cavosurface marginal discoloration, and the presence of caries.
The aim of this study is to provide evidence-based clinical data regarding the durability and performance of direct and indirect composite restorations in posterior teeth.
- Conditions
- Clinical Trial, Dental Caries
- Being tested
- Direct Restoration with Microhybrid Composite, Indirect Restoration with Reinforced Microfill Composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Restoration with Microhybrid CompositeDevice
Direct Class I restorations were placed in molar teeth using a microhybrid universal composite (Aelite All-Purpose Body, Bisco) and an adhesive system according to the manufacturer's instructions.
Indirect Restoration with Reinforced Microfill CompositeDevice
Indirect Class I restorations were fabricated using a reinforced microfill composite system (Tescera Indirect Composite System Body, Bisco) in the laboratory and cemented into molar teeth using resin cement.
| Study group | Role | What they receive |
|---|---|---|
| Direct and Indirect Restorations | Experimental | Participants in this arm received two different types of restorations in Class I cavities of molar teeth: one direct restoration using a microhybrid universal composite, and one indirect restoration using a reinforced microfill composite system. Each patient received one of each restoration type on different molar teeth. Clinical evaluations were conducted at baseline, 1 year, 2 years, and 10 years using modified USPHS criteria. Receives: Device: Direct Restoration with Microhybrid Composite; Device: Indirect Restoration with Reinforced Microfill Composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-Year Clinical Success Rate of Direct and Indirect Restorations
The primary outcome is the clinical success rate of direct and indirect Class I restorations in molar teeth after 10 years. Success and failure were assessed using modified United States Public Health Service (USPHS) criteria. A restoration was considered a failure if it required replacement due to secondary caries or other clinical complications.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startJun 2014
- Primary completionOct 2014
- Study completionJun 2024
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 Clinical TrialStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Tekçe, Kocaeli University
- Investigators
- Neslihan Tekçe, Principal investigator, Kocaeli University, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081529
- Sponsor's protocol ID
- 2014/157
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tekce N, Demirci M, Tuncer S, Oghan Turkoglu M, Turgut V, Balci SN, Yersel G. Clinical evaluation of direct and indirect restorations in class I cavities: a 10-year follow-up study. BMC Oral Health. 2025 Sep 25;25(1):1430. doi: 10.1186/s12903-025-06775-9.
PubMed 40999454
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Direct and Indirect Restorations in Class I Cavities: A 10-Year Follow-up Study
- ClinicalTrials.gov ID
- NCT07081529
- Acronym / sponsor ID
- 2014/157
- Conditions
- Clinical Trial, Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2024 (actual)
- First posted
- 23 Jul 2025 (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 clinical study aims to evaluate and compare the long-term clinical performance of direct and indirect restorations in Class I cavities of molar teeth over a 10-year period. A total of 54 restorations (27 direct and 27 indirect) were placed in 27 patients, with each patient receiving one direct and one indirect restoration. The restorations were evaluated at baseline, and at 1-, 2-, and 10-year follow-ups using modified USPHS criteria.
Detailed description
This prospective clinical study was designed to evaluate and compare the long-term clinical performance of direct and indirect composite restorations in Class I cavities of permanent molar teeth over a 10-year period.
A total of 27 patients were enrolled in the study. Each participant received one direct and one indirect restoration, resulting in a total of 54 restorations (27 direct and 27 indirect).
Direct restorations were performed intraorally using a microhybrid composite and adhesive system in accordance with the manufacturer's instructions. Indirect restorations were fabricated in the laboratory using a reinforced microfill composite system and cemented using resin cement.
All restorations were clinically evaluated at baseline, and at 1-, 2-, and 10-year follow-up appointments. The modified United States Public Health Service (USPHS) criteria were used for evaluation. The assessed parameters included surface texture, anatomic form, color match, marginal adaptation, cavosurface marginal discoloration, and the presence of caries.
The aim of this study is to provide evidence-based clinical data regarding the durability and performance of direct and indirect composite restorations in posterior teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Direct and Indirect Restorations | Experimental | Device: Direct Restoration with Microhybrid Composite, Device: Indirect Restoration with Reinforced Microfill CompositeParticipants in this arm received two different types of restorations in Class I cavities of molar teeth: one direct restoration using a microhybrid universal composite, and one indirect restoration using a reinforced microfill composite system. Each patient received one of each restoration type on different molar teeth. Clinical evaluations were conducted at baseline, 1 year, 2 years, and 10 years using modified USPHS criteria. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients presenting with two Class I cavities
- Good oral hygiene maintenance
- Absence of pulp or periodontal disease
- Requirement for restoration of permanent molars due to occlusal caries
Key exclusion criteria (6 listed)
- Presence of parafunctional habits (e.g., bruxism or clenching)
- Poor oral hygiene
- Lack of interest in or refusal to comply with oral hygiene instructions
- Pulp exposure during caries removal
- Percussion sensitivity indicating possible pulpal or periapical pathology
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 |
|---|---|---|
| Direct Restoration with Microhybrid CompositeDirect Class I restorations were placed in molar teeth using a microhybrid universal composite (Aelite All-Purpose Body, Bisco) and an adhesive system according to the manufacturer's instructions. | Device | Direct and Indirect Restorations |
| Indirect Restoration with Reinforced Microfill CompositeIndirect Class I restorations were fabricated using a reinforced microfill composite system (Tescera Indirect Composite System Body, Bisco) in the laboratory and cemented into molar teeth using resin cement. | Device | Direct and Indirect Restorations |
Primary outcome
10-Year Clinical Success Rate of Direct and Indirect Restorations
Time frame: 10 years
The primary outcome is the clinical success rate of direct and indirect Class I restorations in molar teeth after 10 years. Success and failure were assessed using modified United States Public Health Service (USPHS) criteria. A restoration was considered a failure if it required replacement due to secondary caries or other clinical complications.
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 23 Jul 2025.
- Derived from this study: PubMed 40999454Tekce N, Demirci M, Tuncer S, Oghan Turkoglu M, Turgut V, Balci SN, Yersel G. Clinical evaluation of direct and indirect restorations in class I cavities: a 10-year follow-up study. BMC Oral Health. 2025 Sep 25;25(1):1430. doi: 10.1186/s12903-025-06775-9.
- Individual participant dataSharing planned: No
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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.
Neslihan Tekçe principal investigator
Kocaeli University, Faculty of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Direct Restoration with Microhybrid Composite and Indirect Restoration with Reinforced Microfill Composite in people with Clinical Trial and Dental Caries, run by Kocaeli University.
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 6 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
10-Year Clinical Success Rate of Direct and Indirect Restorations (time frame: 10 years). 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 NCT07081529, 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 23 Jul 2025.