Dental CariesNCT06667271
Clinical Evaluation of Direct and Indirect Composites
An observational study of Dental Caries, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
The most commonly used materials in the treatment of decayed teeth are amalgam and composite resins. Because amalgam cannot meet the aesthetic expectations of patients and the rapidly increasing belief that it is toxic, its use has decreased considerably. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Mar 2023to 1 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The characteristics of the teeth were recorded prior to any restorative procedures. Periapical radiographs were used to assess the status and extent of caries, as well as to identify any potential periodontal or periapical pathologies that might necessitate endodontic treatment. The treated teeth were vital, asymptomatic, and in occlusal contact. Indirect composite restorations were applied to teeth that had caries, old composite or amalgam restorations, secondary caries, or teeth with cuspid loss where the isthmus width exceeded two-thirds of the intercuspal distance.
Who may be able to join
- They have been informed about the study and have agreed to participate.
- They are over 18 years old.
- They do not have any systemic diseases.
- They maintain good general oral health.
- They are not pregnant or breastfeeding.
- The relevant tooth is vital, and the decay is at least 0.5 mm away from the pulp, as confirmed by radiographic findings.
- There is a tooth in contact with the relevant tooth and an antagonist tooth.
- They have agreed to attend follow-up appointments.
Who cannot join
- After being informed about the study, the participant declined to participate.
- The individual is under 18 years of age.
- The volunteer has a severe systemic disease.
- They have active periodontal or pulp disease.
- They have received endodontic treatment.
- They experience bruxism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Posterior Restorations Made With Direct and Indirect Composites
The most commonly used materials in the treatment of decayed teeth are amalgam and composite resins. Because amalgam cannot meet the aesthetic expectations of patients and the rapidly increasing belief that it is toxic, its use has decreased considerably. Although composite resins are primarily used in anterior teeth because they provide aesthetically satisfactory results, they have also become the most preferred material in posterior teeth. This shift is largely due to the significant advancements in their mechanical properties, such as improved strength and durability. Indirect restorations have begun to be used to overcome the disadvantages of resin composites applied with the direct method. Both composite resins and ceramics have given good results for such restorations. However, composite resins have the advantage of being cheaper, more user-friendly, and repairable than ceramics. Laboratory-prepared composite inlays/onlays are more wear-resistant than direct composites, especially in occlusal contact areas. Therefore, they are generally indicated for the restoration of large cavities. Considering the material loss caused by crown restorations and the disadvantages of direct composites in the treatment of teeth with extensive caries, we aimed to treat indirect resin composites that we can apply by making more minimally invasive preparations while supporting the dental tissues.
Read the detailed description
This study was a double-blind randomized controlled clinical trial involving both evaluators and patients. The research compared indirect restorations with direct restorations. Patients receiving treatment were recalled for follow-ups after one week, six months, and twelve months. Restorations were assessed clinically based on modified FDI criteria, which included marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, postoperative sensitivity, secondary caries, and periodontal response. Qualified clinicians conducted the evaluations using a mirror and probe under reflector light. Additionally, bite-wing radiographs were obtained from patients during the 6-month and 12-month follow-ups to assess the development of secondary caries. Differences between adhesives at each time point were analyzed using Fisher's Exact test, while the effect of time on restorations was evaluated with the Wilcoxon Signed Rank test (p < 0.05).
- Conditions
- Dental Caries
- Keywords
- Dental caries, Restorative material, Composite resin, Indirect restorarion
- Medical subject headings
- Dental Caries
What is being measured
The primary outcome is the main question the study is designed to answer.
World Dental Federation criteria (FDI)
1, Clinically very good; 2, clinically good; 3, clinically sufficient; 4, clinically unsatisfactory; 5, clinically poor
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start16 Mar 2023
- Primary completion16 Aug 2024
- Study completion1 Nov 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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Karadaş, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667271
- Sponsor's protocol ID
- RTEUDHFMKARADAS004
- Status last verified
- Jan 2026
- First submitted
- 29 Oct 2024
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Incekara MS, Karadas M. Clinical comparison of direct and indirect class II composite restorations: a prospective 12-month follow-up study. BMC Oral Health. 2025 Jul 19;25(1):1217. doi: 10.1186/s12903-025-06604-z.
PubMed 40684149
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Posterior Restorations Made With Direct and Indirect Composites
- ClinicalTrials.gov ID
- NCT06667271
- Acronym / sponsor ID
- RTEUDHFMKARADAS004
- Conditions
- Dental Caries
- Keywords
- Dental caries, Restorative material, Composite resin, Indirect restorarion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 31 Oct 2024 (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 most commonly used materials in the treatment of decayed teeth are amalgam and composite resins. Because amalgam cannot meet the aesthetic expectations of patients and the rapidly increasing belief that it is toxic, its use has decreased considerably. Although composite resins are primarily used in anterior teeth because they provide aesthetically satisfactory results, they have also become the most preferred material in posterior teeth. This shift is largely due to the significant advancements in their mechanical properties, such as improved strength and durability. Indirect restorations have begun to be used to overcome the disadvantages of resin composites applied with the direct method. Both composite resins and ceramics have given good results for such restorations. However, composite resins have the advantage of being cheaper, more user-friendly, and repairable than ceramics. Laboratory-prepared composite inlays/onlays are more wear-resistant than direct composites, especially in occlusal contact areas. Therefore, they are generally indicated for the restoration of large cavities. Considering the material loss caused by crown restorations and the disadvantages of direct composites in the treatment of teeth with extensive caries, we aimed to treat indirect resin composites that we can apply by making more minimally invasive preparations while supporting the dental tissues.
Detailed description
This study was a double-blind randomized controlled clinical trial involving both evaluators and patients. The research compared indirect restorations with direct restorations. Patients receiving treatment were recalled for follow-ups after one week, six months, and twelve months. Restorations were assessed clinically based on modified FDI criteria, which included marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, postoperative sensitivity, secondary caries, and periodontal response. Qualified clinicians conducted the evaluations using a mirror and probe under reflector light. Additionally, bite-wing radiographs were obtained from patients during the 6-month and 12-month follow-ups to assess the development of secondary caries. Differences between adhesives at each time point were analyzed using Fisher's Exact test, while the effect of time on restorations was evaluated with the Wilcoxon Signed Rank test (p < 0.05).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The characteristics of the teeth were recorded prior to any restorative procedures. Periapical radiographs were used to assess the status and extent of caries, as well as to identify any potential periodontal or periapical pathologies that might necessitate endodontic treatment. The treated teeth were vital, asymptomatic, and in occlusal contact. Indirect composite restorations were applied to teeth that had caries, old composite or amalgam restorations, secondary caries, or teeth with cuspid loss where the isthmus width exceeded two-thirds of the intercuspal distance.
Key inclusion criteria (8 listed)
- They have been informed about the study and have agreed to participate.
- They are over 18 years old.
- They do not have any systemic diseases.
- They maintain good general oral health.
- They are not pregnant or breastfeeding.
Key exclusion criteria (6 listed)
- After being informed about the study, the participant declined to participate.
- The individual is under 18 years of age.
- The volunteer has a severe systemic disease.
- They have active periodontal or pulp disease.
- They have received endodontic treatment.
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
World Dental Federation criteria (FDI)
Time frame: 1 year
1, Clinically very good; 2, clinically good; 3, clinically sufficient; 4, clinically unsatisfactory; 5, clinically poor
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 7 Jan 2026.
- Derived from this study: PubMed 40684149Incekara MS, Karadas M. Clinical comparison of direct and indirect class II composite restorations: a prospective 12-month follow-up study. BMC Oral Health. 2025 Jul 19;25(1):1217. doi: 10.1186/s12903-025-06604-z.
- 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.
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 Caries, run by Recep Tayyip Erdogan 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 8 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 7 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?
World Dental Federation criteria (FDI) (time frame: 1 year). 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 NCT06667271, 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 7 Jan 2026.