Primary Teeth RetainedPhase 2NCT05462808
ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars
A Phase 2 study testing High viscosity glass ionomer cement and Stainless steel crown in people with Primary Teeth Retained, run by Esra Oz at 1 site in Turkey (Türkiye).
Trial summary
Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Teeth Retained
- What is being tested?
- High viscosity glass ionomer cement and Stainless steel crown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2019to 1 Apr 2021
- Phase
- Phase 2
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children with no systemic disease,
- children who had a Frankl Behavioral Scale score 2,
- children who have no occlusal problems or bad habits,
- children presenting between 2-5 caries lesion in primary molars.
Who cannot join
- teeth with presence of radyolusens in furcation and/or periradicular areas,
- teeth with pathologic resorption and internal/external resorption
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department
Isparta, 32260
About this study
Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that releases fluoride, in the following years, the deciduous teeth were removed with a minimally invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without preparation for treatment, has come to the fore.
Read the detailed description
Many restorative materials, especially GIC, have been used for ART procedures, and with the advancing technology, high-viscosity glass ionomer cements with improved mechanical and chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled resin-modified HVGICs have been introduced.
The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed to stop the progression of caries by covering the carious deciduous molars with SSC and cutting their relationship with the oral environment, without the need for local anesthesia and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral environment, the number of bacteria in the environment will also decrease.
- Conditions
- Primary Teeth Retained
- Being tested
- High viscosity glass ionomer cement, Stainless steel crown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High viscosity glass ionomer cementDrug
Also called EQUIA Forte (GC Corp., Leuven, BE)
High viscosity glass ionomer cement
Stainless steel crownDevice
Also called 3M ESPE, St. Paul, USA
Stainless steel crown
| Study group | Role | What they receive |
|---|---|---|
| Atraumatic Restorative Treatment restorations with high-viscosity glass ionomer cement | Experimental | Under cotton roll isolation, teeth were restored with EQUIA Forte cement. A layer of EQUIA Forte Coat was applied with a microbrush on surface and then light cured for 20 s Receives: Drug: High viscosity glass ionomer cement |
| restorations with Hall technique | Experimental | In the Hall technique group, the deposits on the occlusal surface of the teeth were gently removed, SSC (3M ESPE, St. Paul, USA) was placed and were cemented using GIC. The crown was pressed tightly. Receives: Device: Stainless steel crown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hall technique
The restorations were scored as Alpha (A), clinically ideal restoration ''successful''; Bravo (B), clinically ''acceptable''; Charlie (C), clinically unacceptable restoration ''unsuccessful''. Outcomes criteria for assessment of the Hall Technique were made according to Innes et al.
Measured: up to 18 months
Secondary outcomes (1)
Atraumatic restorative treatment
Clinical evaluations of teeth treated with ART using EQUIA Forte were performed according to the modified USPHS criteria established by a modification of the United States Public Health Service (USPHS) clinical evaluation criteria.
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start20 Mar 2019
- Primary completion1 Apr 2019
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Teeth RetainedStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esra Oz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esra Oz, Suleyman Demirel University
- Investigators
- Esra Oz, Study director, Suleyman Demirel University Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462808
- Sponsor's protocol ID
- 2014/157
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 18 Jul 2022
- Results posted
- 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 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars
- ClinicalTrials.gov ID
- NCT05462808
- Acronym / sponsor ID
- 2014/157
- Conditions
- Primary Teeth Retained
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Esra OzUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 18 Jul 2022 (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.
Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that releases fluoride, in the following years, the deciduous teeth were removed with a minimally invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without preparation for treatment, has come to the fore.
Detailed description
Many restorative materials, especially GIC, have been used for ART procedures, and with the advancing technology, high-viscosity glass ionomer cements with improved mechanical and chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled resin-modified HVGICs have been introduced.
The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed to stop the progression of caries by covering the carious deciduous molars with SSC and cutting their relationship with the oral environment, without the need for local anesthesia and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral environment, the number of bacteria in the environment will also decrease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atraumatic Restorative Treatment restorations with high-viscosity glass ionomer cement | Experimental | Drug: High viscosity glass ionomer cementUnder cotton roll isolation, teeth were restored with EQUIA Forte cement. A layer of EQUIA Forte Coat was applied with a microbrush on surface and then light cured for 20 s |
| restorations with Hall technique | Experimental | Device: Stainless steel crownIn the Hall technique group, the deposits on the occlusal surface of the teeth were gently removed, SSC (3M ESPE, St. Paul, USA) was placed and were cemented using GIC. The crown was pressed tightly. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children with no systemic disease,
- children who had a Frankl Behavioral Scale score 2,
- children who have no occlusal problems or bad habits,
- children presenting between 2-5 caries lesion in primary molars.
Key exclusion criteria (2 listed)
- teeth with presence of radyolusens in furcation and/or periradicular areas,
- teeth with pathologic resorption and internal/external resorption
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 |
|---|---|---|
| High viscosity glass ionomer cementAlso: EQUIA Forte (GC Corp., Leuven, BE)High viscosity glass ionomer cement | Drug | Atraumatic Restorative Treatment restorations with high-viscosity glass ionomer cement |
| Stainless steel crownAlso: 3M ESPE, St. Paul, USAStainless steel crown | Device | restorations with Hall technique |
Primary outcome
Hall technique
Time frame: up to 18 months
The restorations were scored as Alpha (A), clinically ideal restoration ''successful''; Bravo (B), clinically ''acceptable''; Charlie (C), clinically unacceptable restoration ''unsuccessful''. Outcomes criteria for assessment of the Hall Technique were made according to Innes et al.
1 secondary outcome
Atraumatic restorative treatment
Time frame: up to 18 months
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 18 Jul 2022.
- Individual participant dataSharing planned: No
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.
Esra Oz study director
Suleyman Demirel University Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High viscosity glass ionomer cement and Stainless steel crown in people with Primary Teeth Retained, run by Esra Oz 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 2 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 18 Jul 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hall technique (time frame: up to 18 months). 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 18 Jul 2022.