Dental CariesNCT06637605
Clinical Comparison of Restorative Materials
An observational study of Dental Caries, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties, excellent esthetic properties, conservative preparation, and successful clinical performance. 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
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2023to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 before the restorative procedures. Periapical radiographs were used to determine the status and extent of caries and any potential periodontal or periapical pathology that might require endodontic treatment. The treated teeth were vital, asymptomatic, and in occlusal contact. As a result of the clinical and radiographic evaluations, teeth with deep caries lesions according to the ESE (European Society of Endodontology) criteria or those with radiographically reaching ¾ of the dentin but with a hard dentin zone between the caries and the pulp were included in the study.
Who may be able to join
- Systemically healthy patients aged 18 and over
- Patients with good oral hygiene.
- Vital teeth are to be included in the study.
- The presence of an antagonist and a contact tooth for the tooth to be restored.
- Teeth with deep caries lesions or radiographically reaching ¾ of the dentin but with a hard dentin region between the caries and the pulp according to ESE (European Society of Endodontology) criteria.
Who cannot join
- Patients with a history of bruxism and periodontal disease
- Patients under 18 years of age
- Spontaneous pain in the tooth to be restored
- Intense carious lesion reaching the entire thickness of the dentin according to ESE (European Society of Endodontology) criteria
- Observation of mechanical perforation during caries cleaning
- Patients suspected of pregnancy or pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Different Restorative Materials in Deep Cavities
Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties, excellent esthetic properties, conservative preparation, and successful clinical performance. However, resin-based composite materials in deep cavities are more likely to irritate the pulp tissue due to insufficient polymerization and residual monomer release. Therefore, glass ionomer-based restorative materials can be used more successfully in deep cavities. In addition, the hardening mechanisms of high-viscosity glass ionomer cement are the same as those of conventional glass ionomer cement, and their wear resistance, surface hardness, compression, and bending strength are increased. No clinical studies evaluate the performance of different restorative materials in deep cavities. This clinical study aims to evaluate the clinical performance of high-viscosity glass ionomer, bulk-fill composite, and conventional composite in deep cavities.
Read the detailed description
This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in deep cavities.
The treated patients were called back for controls after one week, six months, and twelve months. Restorations were evaluated clinically according to modified FDI criteria (marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, post-operative sensitivity, secondary caries and periodontal response).
Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 12-month to evaluate the formation of secondary caries.
Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p < 0.05).
- Conditions
- Dental Caries
- Keywords
- Dental caries, Restorative material, Composite resin, Deep caries
- 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)
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 posted15 Oct 2024
- Study start23 Feb 2023
- Primary completion23 Aug 2024
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 110 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
- NCT06637605
- Sponsor's protocol ID
- RTEUDHFMKARADAS003
- Status last verified
- Jan 2026
- First submitted
- 8 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
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 Different Restorative Materials in Deep Cavities
- ClinicalTrials.gov ID
- NCT06637605
- Acronym / sponsor ID
- RTEUDHFMKARADAS003
- Conditions
- Dental Caries
- Keywords
- Dental caries, Restorative material, Composite resin, Deep caries
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 15 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.
Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties, excellent esthetic properties, conservative preparation, and successful clinical performance. However, resin-based composite materials in deep cavities are more likely to irritate the pulp tissue due to insufficient polymerization and residual monomer release. Therefore, glass ionomer-based restorative materials can be used more successfully in deep cavities. In addition, the hardening mechanisms of high-viscosity glass ionomer cement are the same as those of conventional glass ionomer cement, and their wear resistance, surface hardness, compression, and bending strength are increased. No clinical studies evaluate the performance of different restorative materials in deep cavities. This clinical study aims to evaluate the clinical performance of high-viscosity glass ionomer, bulk-fill composite, and conventional composite in deep cavities.
Detailed description
This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in deep cavities.
The treated patients were called back for controls after one week, six months, and twelve months. Restorations were evaluated clinically according to modified FDI criteria (marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, post-operative sensitivity, secondary caries and periodontal response).
Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 12-month to evaluate the formation of secondary caries.
Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using 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 before the restorative procedures. Periapical radiographs were used to determine the status and extent of caries and any potential periodontal or periapical pathology that might require endodontic treatment. The treated teeth were vital, asymptomatic, and in occlusal contact. As a result of the clinical and radiographic evaluations, teeth with deep caries lesions according to the ESE (European Society of Endodontology) criteria or those with radiographically reaching ¾ of the dentin but with a hard dentin zone between the caries and the pulp were included in the study.
Key inclusion criteria (5 listed)
- Systemically healthy patients aged 18 and over
- Patients with good oral hygiene.
- Vital teeth are to be included in the study.
- The presence of an antagonist and a contact tooth for the tooth to be restored.
- Teeth with deep caries lesions or radiographically reaching ¾ of the dentin but with a hard dentin region between the caries and the pulp according to ESE (European Society of Endodontology) criteria.
Key exclusion criteria (6 listed)
- Patients with a history of bruxism and periodontal disease
- Patients under 18 years of age
- Spontaneous pain in the tooth to be restored
- Intense carious lesion reaching the entire thickness of the dentin according to ESE (European Society of Endodontology) criteria
- Observation of mechanical perforation during caries cleaning
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- 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 5 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
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.