Caries; DentinNCT03037814
Clinical Performance of Restorative Materials in Primary Teeth
A study testing Compomer, RMGIC and Giomer in people with Caries; Dentin and Dental Caries, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate and compare the clinical performance of dental restorative materials in Class II cavities of primary molar teeth Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries; Dentin, Dental Caries
- What is being tested?
- Compomer, RMGIC and Giomer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2021to 25 Mar 2027
- Phase
- Interventional
- 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 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients and parent of the patients who accept to participate and sign the informed consent
- Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
- Teeth that have healthy lamina dura and periodontal ligament
- Teeth that have caries lesions extending no more than the outher half of dentin radiographically
Who cannot join
- Patients and parent of the patients who don't accept to participate and sign the informed consent
- Teeth that are previously restored
- Patients who are uncooperative
- Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
- Patients who have bruxism, skeletal or dental malocclusion
- Teeth that have developmental defects or anomalies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth
The purpose of this study is to evaluate and compare the clinical performance of dental restorative materials in Class II cavities of primary molar teeth
Read the detailed description
Restorations will be placed on four primary molar teeth with proximal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.
Group 1: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.
- Conditions
- Caries; Dentin, Dental Caries
- Being tested
- Compomer, RMGIC, Giomer, Amalgam
- Keywords
- restorative materials, primary teeth, children
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompomerDevice
Aesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements.
RMGICDevice
Dental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins.
GiomerDevice
Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
AmalgamDevice
Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
| Study group | Role | What they receive |
|---|---|---|
| Compomer | Other | Adhesive agent+Compomer Receives: Device: RMGIC; Device: Giomer; Device: Amalgam |
| RMGIC | Other | Primer+RMGIC Receives: Device: Compomer; Device: Giomer; Device: Amalgam |
| Giomer | Other | Adhesive Agent+ Giomer Receives: Device: Compomer; Device: RMGIC; Device: Amalgam |
| Amalgam | Other | Amalgam Receives: Device: Compomer; Device: RMGIC; Device: Giomer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
Long-term clinical success of different restorative materials in class II cavities on primary molar teeth
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start28 Sep 2021 (estimated)
- Primary completion25 Jul 2026 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries; DentinStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Cavit Cehreli, DDS, PhD, Hacettepe University
- Investigators
- Zafer C Cehreli, DDS, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037814
- Sponsor's protocol ID
- HUDHF-3-primary teeth
- Status last verified
- Mar 2021
- First submitted
- 29 Jan 2017
- Last updated
- 15 Mar 2021
- 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 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Restorative Materials in Class II Cavities of Primary Molar Teeth
- ClinicalTrials.gov ID
- NCT03037814
- Acronym / sponsor ID
- HUDHF-3-primary teeth
- Conditions
- Caries; Dentin, Dental Caries
- Keywords
- restorative materials, primary teeth, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Sep 2021 (estimated)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 31 Jan 2017 (estimated)
- 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 purpose of this study is to evaluate and compare the clinical performance of dental restorative materials in Class II cavities of primary molar teeth
Detailed description
Restorations will be placed on four primary molar teeth with proximal caries, in a split mouth design. 100 patients will be included in the study. The teeth will be randomized into four groups according to the restorative materials.
Group 1: Adhesive agent+ Compomer (Dyract AP, Dentsply DeTrey, Konstanz,Germany) Group 2: Primer + Resin modified glass ionomer (Vitremer, 3M ESPE, U.S.) Group 3: Adhesive agent + Giomer (Beautifil II, (Shofu Dental, Tokyo, Japan) Group 4: Amalgam (Permite amalgam, SDI Limited, Bayswater, Australia) The restorations will be evaluated at baseline, 3., 6., 12. months for the first year, and at every 6 months for 5 years. The modified US Public Health Service criteria (secondary caries, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of restorations. The data will be analysed statistically using Wilcoxon test, chi square test and the Kaplan-Meier survival method will be used to estimate survival percentages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Compomer | Other | Device: RMGIC, Device: Giomer, Device: AmalgamAdhesive agent+Compomer |
| RMGIC | Other | Device: Compomer, Device: Giomer, Device: AmalgamPrimer+RMGIC |
| Giomer | Other | Device: Compomer, Device: RMGIC, Device: AmalgamAdhesive Agent+ Giomer |
| Amalgam | Other | Device: Compomer, Device: RMGIC, Device: GiomerAmalgam |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients and parent of the patients who accept to participate and sign the informed consent
- Patients who have at least four first and/or second primary molars with proximal caries that require class II restorations
- Teeth that have healthy lamina dura and periodontal ligament
- Teeth that have caries lesions extending no more than the outher half of dentin radiographically
Key exclusion criteria (6 listed)
- Patients and parent of the patients who don't accept to participate and sign the informed consent
- Teeth that are previously restored
- Patients who are uncooperative
- Teeth that doesn't have proximal or occlusal contacts with adjacent healthy teeth
- Patients who have bruxism, skeletal or dental malocclusion
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 |
|---|---|---|
| CompomerAesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements. | Device | Amalgam, Giomer, RMGIC |
| RMGICDental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins. | Device | Amalgam, Compomer, Giomer |
| GiomerGiomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries. | Device | Amalgam, Compomer, RMGIC |
| AmalgamAmalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries. | Device | Compomer, Giomer, RMGIC |
Primary outcome
Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria
Time frame: 5 years
Long-term clinical success of different restorative materials in class II cavities on primary molar teeth
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 15 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Caries; Dentin
Not yet recruiting
Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars
Decayed Primary Molars, Decayed Tooth
Active, not recruiting
Two-year Clinical Performance of Ion-releasing and Conventional Bulk-fill Resin Composite Restorative Systems.
Class I Dental Caries
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Clinical Evaluation of Dentin Replacement Materials in Posterior Composite Restorations
Dental Caries, Composite Resins
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.
Zafer C Cehreli, DDS, PhD principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compomer, RMGIC and Giomer in people with Caries; Dentin and Dental Caries, run by Hacettepe 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 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: opening soon, as of the sponsor's last update on 15 Mar 2021. 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?
Contact Zafer C Cehreli, DDS, PhD (00905353197969, zcehreli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of restorative materials in class II cavities on primary molar teeth according to the modified USPHS criteria (time frame: 5 years). 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 15 Mar 2021.