Dentin CariesNCT04813744
Microbiological and Microscopic Evaluation of Atraumatic Restorative Treatment in Adult Dentition
A study testing Atraumatic restorative treatment in people with Dentin Caries and Infection, run by Istanbul University.
Trial summary
Atraumatic Restorative Treatment (ART) was proposed as a new and effective method in the 1990s to provide conservative dental treatment to the people living in economically underdeveloped countries, due to lack of dental treatment facilities. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentin Caries, Infection
- What is being tested?
- Atraumatic restorative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 9 May 2009to 3 Mar 2011
- 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 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients:
- 19-35 years of age;
- Good general health;
- High risk of caries;
- No evident signs of occlusal parafunctions.
- Tooth:
Show all 11Show fewer
- Molar tooth;
- 3-4 mm depth occlusal dentin caries;
- Vital;
- In occlusion;
- Proper tooth axes.
Who cannot join
- Patient:
- Using regular medication;
- Pregnancy or lactation;
- Received radiotherapy or chemotherapy;
- Tooth clenching, bruxism.
- Tooth:
Show all 11Show fewer
- Spontaneous pain;
- Radiographic alterations in the periapical region;
- Presence of tooth mobility;
- Previously restored;
- Broken and/ or cracked.
About this study
Official title: Investigation of Atraumatic Restorative Treatment by in Vivo and in Vitro Methods in Terms of the Microbiological, Marginal Adaptation and Microleakage
Atraumatic Restorative Treatment (ART) was proposed as a new and effective method in the 1990s to provide conservative dental treatment to the people living in economically underdeveloped countries, due to lack of dental treatment facilities. In the technique, after the carious dentin is removed by excavation with hand instruments, the powder-liquid system conventional glass ionomer cement (GIC) which does not require special devices for mixing and hardening is used as a filling material. Because of these advantages of the treatment, the usage fields of ART have been expanded considering that it can be applied in the cases that working with rotary instruments is difficult or even impossible. But only a few research has been conducted on ART in adults and it must be investigated in terms of the clinical safety of ART by the studies focused on the counts and activities of the microorganisms in carious dentin left on the cavity floor. The purpose of this study is to investigate the reliability of ART in adult individuals related to the marginal adaptation of the restorations and the microbiological changes in the left carious dentin using in vitro and in vivo methods. In the in vivo part of the study, occlusal dentin carious of 25 participants at high risk of caries were removed with hand instruments and microorganisms of the last removed carious dentin were evaluated quantitatively concerning the bacterias playing a major role in caries lesions. The restorations of the teeth were carried out using ART technique with a GIC which has been proven its effectiveness in preventing the caries progression and recurrent caries in the practice of dentistry for many years. After six months, the microbiological assessment was repeated such as baseline. Marginal adaptation and the presence of the gaps in the ART restorations on the replicas created with the impression materials at the baseline and sixth month were investigated under scanning electron microscope. At the end of the study, the teeth were restored by the conventional methods and using composite material.
- Conditions
- Dentin Caries, Infection
- Being tested
- Atraumatic restorative treatment
- Keywords
- Atraumatic restorative treatment, Glass ionomer cement, Marginal adaptation
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atraumatic restorative treatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Investigation of atraumatic restorative treatment in adults with a high risk of caries | Experimental | The study group included a total of 25 healthy individuals with high caries risk who had molar teeth in their mouth with 3-4 mm depth occlusal dentin caries. In the clinical study, the infected and demineralized dentin was cleaned manually with a sterile excavator. The dentin sample was taken from the last removable and affected dentin layer at the cavity floor by one excavation for microbiological assessment. The teeth were restored with a conventional glass ionomer cement. In the 6th month, restorations were removed by using low-speed round steel bur, and the dentin samples were removed with an excavator from the cavity floor to repeat the microbiological assessment. In the first week and 6th month of atraumatic restorative treatment, the impressions were taken from the restored teeth to prepare replicas. The replicas of the twenty teeth out of 25 were randomly selected to evaluate of marginal adaptation under scanning electron microscopy. Receives: Procedure: Atraumatic restorative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of microbiological parameters
Change at the counts of microorganisms
Measured: 6 months
Microscopic analyses of the marginal gap formation
Change at the marginal integrity of restorations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start9 May 2009
- Primary completion3 Mar 2011
- Study completion3 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentin CariesStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Not applicable
- Intervention model
- Single group
- Model description
- The clinical studies were carried out in the occlusal dentin caries of 25 permanent molar teeth in participants with high caries risk and between 19-35 years of age. The caries tissue were removed with hand instruments in accordance procedure of atraumatic restorative treatment. Then the total counts of bacteria, facultative anaerobe bacteria, Mutans Streptococci, and Lactobacilli supp. counts in the affected dentin were evaluated quantitatively. The weights of samples were measured with an electronic balance (Shimadzu, Type AX200, Japan). The cavities were restored with a glass ionomer cement (KetacTM Molar Easymix, ESPE Dental AG, Seefeld, Germany). Twenty replicas of randomly selected ART restorations were prepared and marginal adaptation was evaluated by scanning electron microscopy. After 6 months, the same protocols were repeated. Data were analyzed with Paired Sample and Wilcoxon Paired t-tests, Pearson, Spearman correlation, and Chi-Square tests (p\< 0.05).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Tekbas Atay, Istanbul University
- Investigators
- Meltem Tekbas Atay, PhD, Principal investigator, Department of Restorative Dentistry, Faculty of Dentistry, Trakya University, Edirne, TurkeyFatma Koray, Prof. Dr., Study chair, Department of Restorative Dentistry, Faculty of Dentistry, Yeniyüzyıl University, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813744
- Sponsor's protocol ID
- 1432
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Atraumatic Restorative Treatment by in Vivo and in Vitro Methods in Terms of the Microbiological, Marginal Adaptation and Microleakage
- ClinicalTrials.gov ID
- NCT04813744
- Acronym / sponsor ID
- 1432
- Conditions
- Dentin Caries, Infection
- Keywords
- Atraumatic restorative treatment, Glass ionomer cement, Marginal adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 9 May 2009 (actual)
- Primary completion
- 3 Mar 2011 (actual)
- Study completion
- 3 Mar 2011 (actual)
- First posted
- 24 Mar 2021 (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.
Atraumatic Restorative Treatment (ART) was proposed as a new and effective method in the 1990s to provide conservative dental treatment to the people living in economically underdeveloped countries, due to lack of dental treatment facilities. In the technique, after the carious dentin is removed by excavation with hand instruments, the powder-liquid system conventional glass ionomer cement (GIC) which does not require special devices for mixing and hardening is used as a filling material. Because of these advantages of the treatment, the usage fields of ART have been expanded considering that it can be applied in the cases that working with rotary instruments is difficult or even impossible. But only a few research has been conducted on ART in adults and it must be investigated in terms of the clinical safety of ART by the studies focused on the counts and activities of the microorganisms in carious dentin left on the cavity floor. The purpose of this study is to investigate the reliability of ART in adult individuals related to the marginal adaptation of the restorations and the microbiological changes in the left carious dentin using in vitro and in vivo methods. In the in vivo part of the study, occlusal dentin carious of 25 participants at high risk of caries were removed with hand instruments and microorganisms of the last removed carious dentin were evaluated quantitatively concerning the bacterias playing a major role in caries lesions. The restorations of the teeth were carried out using ART technique with a GIC which has been proven its effectiveness in preventing the caries progression and recurrent caries in the practice of dentistry for many years. After six months, the microbiological assessment was repeated such as baseline. Marginal adaptation and the presence of the gaps in the ART restorations on the replicas created with the impression materials at the baseline and sixth month were investigated under scanning electron microscope. At the end of the study, the teeth were restored by the conventional methods and using composite material.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The clinical studies were carried out in the occlusal dentin caries of 25 permanent molar teeth in participants with high caries risk and between 19-35 years of age. The caries tissue were removed with hand instruments in accordance procedure of atraumatic restorative treatment. Then the total counts of bacteria, facultative anaerobe bacteria, Mutans Streptococci, and Lactobacilli supp. counts in the affected dentin were evaluated quantitatively. The weights of samples were measured with an electronic balance (Shimadzu, Type AX200, Japan). The cavities were restored with a glass ionomer cement (KetacTM Molar Easymix, ESPE Dental AG, Seefeld, Germany). Twenty replicas of randomly selected ART restorations were prepared and marginal adaptation was evaluated by scanning electron microscopy. After 6 months, the same protocols were repeated. Data were analyzed with Paired Sample and Wilcoxon Paired t-tests, Pearson, Spearman correlation, and Chi-Square tests (p< 0.05).
| Arm | Type | Receives |
|---|---|---|
| Investigation of atraumatic restorative treatment in adults with a high risk of caries | Experimental | Procedure: Atraumatic restorative treatmentThe study group included a total of 25 healthy individuals with high caries risk who had molar teeth in their mouth with 3-4 mm depth occlusal dentin caries. In the clinical study, the infected and demineralized dentin was cleaned manually with a sterile excavator. The dentin sample was taken from the last removable and affected dentin layer at the cavity floor by one excavation for microbiological assessment. The teeth were restored with a conventional glass ionomer cement. In the 6th month, restorations were removed by using low-speed round steel bur, and the dentin samples were removed with an excavator from the cavity floor to repeat the microbiological assessment. In the first week and 6th month of atraumatic restorative treatment, the impressions were taken from the restored teeth to prepare replicas. The replicas of the twenty teeth out of 25 were randomly selected to evaluate of marginal adaptation under scanning electron microscopy. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 19-35 years of age;
- Good general health;
- High risk of caries;
- No evident signs of occlusal parafunctions.
- Molar tooth;
Key exclusion criteria (11 listed)
- Using regular medication;
- Pregnancy or lactation;
- Received radiotherapy or chemotherapy;
- Tooth clenching, bruxism.
- Spontaneous pain;
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 |
|---|---|---|
| Atraumatic restorative treatment | Procedure or surgery | Investigation of atraumatic restorative treatment in adults with a high risk of caries |
Primary outcome
Evaluation of microbiological parameters
Time frame: 6 months
Change at the counts of microorganisms
Microscopic analyses of the marginal gap formation
Time frame: 6 months
Change at the marginal integrity of restorations
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 24 Mar 2021.
- 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.
Meltem Tekbas Atay, PhD principal investigator
Department of Restorative Dentistry, Faculty of Dentistry, Trakya University, Edirne, Turkey
Fatma Koray, Prof. Dr. study chair
Department of Restorative Dentistry, Faculty of Dentistry, Yeniyüzyıl University, Istanbul, Turkey
Questions about this trial
What is this clinical trial studying?
A study testing Atraumatic restorative treatment in people with Dentin Caries and Infection, run by Istanbul 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 11 inclusion and 11 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 24 Mar 2021. 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?
Evaluation of microbiological parameters (time frame: 6 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 24 Mar 2021.