HypersensitiveMIH_GICNCT05945381
Effect of Glass-Ionomer Sealing Technique on Hypersensitive Teeth With Molar Incisor Hypomineralisation
A study testing GIC on MIH in people with Hypersensitive and Molar Incisor Hypomineralization, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
This single armed cohort study is aimed to assess the acceptance, durability and efficiency of glass-Ionomer sealing technique on hypersensitive MIH molars (TNI-3 \& 4a/b/c) clinically shortly (15 minutes) after the application and after a time period of 3 months. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitive, Molar Incisor Hypomineralization, Pit and Fissure Sealants
- What is being tested?
- GIC on MIH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to Dec 2024
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Self-reported hypersensitive MIH molar (MIH-TNI 3 \& 4a/b/c).
- Children \& adolescents without systematic health diseases.
- No sealing therapy or application of desensitizing agent on the MIH-teeth within 1 month before participation in the study.
- Agreement to voluntary participation in the study.
Who cannot join
- Patients with acute pain/ patients with signs or symptoms to be treated.
- Patients with systemic disease that require special attention during their dental treatment.
- Parents / children who refused to participate in the study. - MIH teeth with signs of irreversible pulpitis.
- Allergy against any ingredients of the material.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Preventive and Pediatric Dentistry, University of Greifswald
Greifswald, D-17457
Christian Splieth, Prof. Dr., 0049 3834 867101, splieth@uni-greifswald.de
Julian Schmoeckel, Dr., 0049 3834 867167, juilan.schmoeckel@uni-greifswald.de
About this study
Official title: Evaluation of Efficiency, Acceptance and the Durability of Glass-Ionomer Sealing Technique on Hypersensitive MIH (Molar Incisor Hypomineralisation) Teeth With and Without Enamel Breakdown - a Cohort Study
This single armed cohort study is aimed to assess the acceptance, durability and efficiency of glass-Ionomer sealing technique on hypersensitive MIH molars (TNI-3 \& 4a/b/c) clinically shortly (15 minutes) after the application and after a time period of 3 months.
Read the detailed description
The main assumption of the study is that sealing of hypersensitive MIH molars (TNI-3 \& 4a/b/c) using glass-ionomer cement reduces the degree of hypersensitivity after direct placement and within a period of time. Moreover, glass-ionomer sealing has a good durability in hypomineralized teeth and is known to be acceptable due to it's easy and fast application.
The aim of this study is to assess the change in the degree of hypersensitivity in the sealed MIH (molar incisor hypomineralisation) tooth / teeth (IonoStar Plus, VOCO-Germany) in the same visit (15 Minutes after the application) and in the 3 months' recall-visit according to Schiff Cold Air Sensitivity (SCASS) Test and the self-report of the patient using Wong- Baker Faces Rating Scale.
This single armed cohort study will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald from approximately May 2023 to Autumn 2024. After assessment of eligibility and informed consent for participation in the study, hypersensitivity of the affected MIH permanent molars will be assessed using air blast before the treatment using SCASS (Schiff cold air sensitivity Scale) and VAS (Visual analogue scale) in order to record the degree of sensitivity and pain perception of the child. After initial assessment, the affected teeth are prepared to receive a Glass- Ionomer cement fissure sealant (IonoStar Plus, VOCO GmbH Germany).
The level of tooth sensitivity will be assessed again 15 minutes after the treatment and in the regular 3 months follow up via air blast test (Schiff Cold Air Sensitivity Scale), the pain perception is being recorded with VAS (Visual analogue scale) by an independent observer, dental assistant and the operating dentist. The independent observer will assess the cooperation and behaviour of the child throughout the treatment using FBRS (Frankl behavioural rating scale) and FIS (Facial image scale).
The durability of the fissure sealant will be assessed using the modified USPHS criteria in the 3 months' follow-up. After the dental visit, the participating child the accompanying parent or caregiver, the dental operator receives a short questionnaire to be filled out.
- Being tested
- GIC on MIH
- Medical subject headings
- Hypersensitivity, Molar Hypomineralization, Van der Woude syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIC on MIHCombination product
Subjects will be seated in a dental chair set-up using standard infection control guidelines. Then the study and its objectives will be explained to the patients and their caregivers. The tooth will be cleaned with a prophylactic paste and brush for complete debris and plaque removal. The tooth will then be dried with a cotton roll, as the patient doesn't tolerate the air-drying (which is the case in SCASS 2 and 3). Moisture control will be kept with cotton roll, the tooth is then sealed with a hard setting glass-ionomer cement (IonoStar Plus, VOCO, Germany) followed by an application of a surface coat (Easy Glaze, VOCO, Germany) for moisture and dehydration protection after sealant application. The distributed questionnaire will include questions regarding the attitude of the child's caregiver to the idea and their estimation of the child's fair regarding dental visit.
| Study group | Role | What they receive |
|---|---|---|
| GIC on MIH | Experimental | see below Receives: Combination Product: GIC on MIH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypersensitivity (mid-term)
Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) in the 3 months' recall-visit according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0)
Measured: 3 months
Hypersensitivity (short-term)
Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) after 15 minutes according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0)
Measured: 15 minutes
Secondary outcomes (3)
child acceptance of procedure
- Assessment of acceptance of the child toward the procedure using Likert Scale (scale: 1-5)
Measured: 15 minutes
hypersensitivity: assessment of the child
Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) regarding self-report of the patient using Wong- Baker Faces Rating Scale. (0-10; 0=no hurt; 10=hurts worst)
Measured: 15 minutes
durability
Evaluation of durability of the sealant material on the MIH-teeth using modified USPHS assessment's criteria (in 3 months' recall).
Scale Alpha: No loss of sealing material Bravo: Partial loss of sealing material Charlie: Loss of restorative material
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 May 2023
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The tooth will be cleaned with a prophylactic paste and brush for complete debris and plaque removal. The tooth will then be dried with a cotton roll, as the patient doesn't tolerate the air-drying (which is the case in SCASS 2 and 3). Moisture control will be kept with cotton roll, the tooth is then sealed with a hard setting glass-ionomer cement (IonoStar Plus, VOCO, Germany) followed by an application of a surface coat (Easy Glaze, VOCO, Germany) for moisture and dehydration protection after sealant application. The distributed questionnaire will include questions regarding the attitude of the child's caregiver to the idea and their estimation of the child's fair regarding dental visit.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian H Splieth, Prof., Study director, Dep. preventive & pediatric dentistry, University of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945381
- Sponsor's protocol ID
- BB 047/23
- Acronym
- MIH_GIC
- Status last verified
- Jul 2023
- First submitted
- 6 Jun 2023
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficiency, Acceptance and the Durability of Glass-Ionomer Sealing Technique on Hypersensitive MIH (Molar Incisor Hypomineralisation) Teeth With and Without Enamel Breakdown - a Cohort Study
- ClinicalTrials.gov ID
- NCT05945381
- Acronym / sponsor ID
- MIH_GIC / BB 047/23
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jul 2023 (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.
This single armed cohort study is aimed to assess the acceptance, durability and efficiency of glass-Ionomer sealing technique on hypersensitive MIH molars (TNI-3 \& 4a/b/c) clinically shortly (15 minutes) after the application and after a time period of 3 months.
Detailed description
The main assumption of the study is that sealing of hypersensitive MIH molars (TNI-3 \& 4a/b/c) using glass-ionomer cement reduces the degree of hypersensitivity after direct placement and within a period of time. Moreover, glass-ionomer sealing has a good durability in hypomineralized teeth and is known to be acceptable due to it's easy and fast application.
The aim of this study is to assess the change in the degree of hypersensitivity in the sealed MIH (molar incisor hypomineralisation) tooth / teeth (IonoStar Plus, VOCO-Germany) in the same visit (15 Minutes after the application) and in the 3 months' recall-visit according to Schiff Cold Air Sensitivity (SCASS) Test and the self-report of the patient using Wong- Baker Faces Rating Scale.
This single armed cohort study will be undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald from approximately May 2023 to Autumn 2024. After assessment of eligibility and informed consent for participation in the study, hypersensitivity of the affected MIH permanent molars will be assessed using air blast before the treatment using SCASS (Schiff cold air sensitivity Scale) and VAS (Visual analogue scale) in order to record the degree of sensitivity and pain perception of the child. After initial assessment, the affected teeth are prepared to receive a Glass- Ionomer cement fissure sealant (IonoStar Plus, VOCO GmbH Germany).
The level of tooth sensitivity will be assessed again 15 minutes after the treatment and in the regular 3 months follow up via air blast test (Schiff Cold Air Sensitivity Scale), the pain perception is being recorded with VAS (Visual analogue scale) by an independent observer, dental assistant and the operating dentist. The independent observer will assess the cooperation and behaviour of the child throughout the treatment using FBRS (Frankl behavioural rating scale) and FIS (Facial image scale).
The durability of the fissure sealant will be assessed using the modified USPHS criteria in the 3 months' follow-up. After the dental visit, the participating child the accompanying parent or caregiver, the dental operator receives a short questionnaire to be filled out.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The tooth will be cleaned with a prophylactic paste and brush for complete debris and plaque removal. The tooth will then be dried with a cotton roll, as the patient doesn't tolerate the air-drying (which is the case in SCASS 2 and 3). Moisture control will be kept with cotton roll, the tooth is then sealed with a hard setting glass-ionomer cement (IonoStar Plus, VOCO, Germany) followed by an application of a surface coat (Easy Glaze, VOCO, Germany) for moisture and dehydration protection after sealant application. The distributed questionnaire will include questions regarding the attitude of the child's caregiver to the idea and their estimation of the child's fair regarding dental visit.
| Arm | Type | Receives |
|---|---|---|
| GIC on MIH | Experimental | Combination Product: GIC on MIHsee below |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Self-reported hypersensitive MIH molar (MIH-TNI 3 \& 4a/b/c).
- Children \& adolescents without systematic health diseases.
- No sealing therapy or application of desensitizing agent on the MIH-teeth within 1 month before participation in the study.
- Agreement to voluntary participation in the study.
Key exclusion criteria (4 listed)
- Patients with acute pain/ patients with signs or symptoms to be treated.
- Patients with systemic disease that require special attention during their dental treatment.
- Parents / children who refused to participate in the study. - MIH teeth with signs of irreversible pulpitis.
- Allergy against any ingredients of the material.
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 |
|---|---|---|
| GIC on MIHSubjects will be seated in a dental chair set-up using standard infection control guidelines. Then the study and its objectives will be explained to the patients and their caregivers. The tooth will be cleaned with a prophylactic paste and brush for complete debris and plaque removal. The tooth will then be dried with a cotton roll, as the patient doesn't tolerate the air-drying (which is the case in SCASS 2 and 3). Moisture control will be kept with cotton roll, the tooth is then sealed with a hard setting glass-ionomer cement (IonoStar Plus, VOCO, Germany) followed by an application of a surface coat (Easy Glaze, VOCO, Germany) for moisture and dehydration protection after sealant application. The distributed questionnaire will include questions regarding the attitude of the child's caregiver to the idea and their estimation of the child's fair regarding dental visit. | Combination product | GIC on MIH |
Primary outcome
Hypersensitivity (mid-term)
Time frame: 3 months
Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) in the 3 months' recall-visit according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0)
Hypersensitivity (short-term)
Time frame: 15 minutes
Change in the degree of hypersensitivity in the sealed MIH tooth / teeth (IonoStar Plus, VOCO-Germany) after 15 minutes according to Schiff Cold Air Sensitivity (SCASS) Test. (scale: 0;1;2;3; max hypersensitivity: 3; no hypersensitivity 0)
3 secondary outcomes
child acceptance of procedure
Time frame: 15 minutes
hypersensitivity: assessment of the child
Time frame: 15 minutes
durability
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- 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.
Christian H Splieth, Prof. study director
Dep. preventive & pediatric dentistry, University of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIC on MIH in people with Hypersensitive and Molar Incisor Hypomineralization, run by University Medicine Greifswald at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim Ramiar, MSc (+49 3834 867136, karim.ramiar@stud.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypersensitivity (mid-term) (time frame: 3 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 14 Jul 2023.