Molar Incisor HypomineralizationNCT04685889
Resin Infiltration Treatment for MIH
A study testing Resin infiltration in people with Molar Incisor Hypomineralization and Enamel Hypoplasia, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization, Enamel Hypoplasia, Enamel Caries
- What is being tested?
- Resin infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2018to 20 Dec 2019
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH.
Who cannot join
- Dental caries and filling on anterior teeth.
- Dental anomaly on anterior teeth.
- Undergoing orthodontic treatment.
- Periodontal diseases.
- Cognitive and behavioural problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa University
Tokat Province, 60100
About this study
Official title: Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces
The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.
Read the detailed description
A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control).
Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.
Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.
Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.
- Being tested
- Resin infiltration
- Keywords
- molar incisor hypomineralisation, resin infiltration, discoloration, enamel, lesion
- Medical subject headings
- Molar Hypomineralization, Dental Enamel Hypoplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationProcedure or surgery
A sufficient amount of HCl was applied to the lesion using the icon etch syringe included in the set and was allowed to sit for 2 minutes. After washing with water for 30 seconds, the tooth was dried using an air spray. Once the enamel surface appeared chalky, Icon® dry application was initiated.
Ethanol was applied to the lesion using the Icon® dry syringe included in the set, and after 30 seconds it was dried using an air spray. Sufficient amount of resin infiltrant was applied to the lesion using the Icon® infiltrant syringe. The resin infiltrant was applied to the lesion surface by massaging with the tip of the syringe in circular movements for 3 minutes such that it penetrates the surface thoroughly. The resin infiltrant was polymerized for 40 seconds with a light device.
| Study group | Role | What they receive |
|---|---|---|
| Icon Group | Active comparator | Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure. Receives: Procedure: Resin infiltration |
| Control Group | No intervention | No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Mineralisation degree
MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)
Measured: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Changes in the lesion colour
Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths)
Measured: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Lesion size evaluated using cross polarization technique
Changes in the MIH lesions size was evaluated using cross polarization technique
Measured: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start23 May 2018
- Primary completion23 Jun 2018
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halenur Altan, Tokat Gaziosmanpasa University
- Investigators
- Halenur Altan, assoc. prof., Study director, Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric DentistryRabia Erağca Yılmaz, Msc. Dt., Principal investigator, Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685889
- Sponsor's protocol ID
- 2018/35
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
PubMed 11641576Jeremias F, de Souza JF, Silva CM, Cordeiro Rde C, Zuanon AC, Santos-Pinto L. Dental caries experience and Molar-Incisor Hypomineralization. Acta Odontol Scand. 2013 May-Jul;71(3-4):870-6. doi: 10.3109/00016357.2012.734412. Epub 2013 Jan 28.
PubMed 23351220Jalevik B, Noren JG. Enamel hypomineralization of permanent first molars: a morphological study and survey of possible aetiological factors. Int J Paediatr Dent. 2000 Dec;10(4):278-89. doi: 10.1046/j.1365-263x.2000.00210.x.
PubMed 11310241Fearne J, Anderson P, Davis GR. 3D X-ray microscopic study of the extent of variations in enamel density in first permanent molars with idiopathic enamel hypomineralisation. Br Dent J. 2004 May 22;196(10):634-8; discussion 625. doi: 10.1038/sj.bdj.4811282.
PubMed 15153976Dantas-Neta NB, Soares Figueiredo M, Lima CCB, Bendo CB, Matos de Andrade EM, Lima MDM, Pordeus IA, Paiva SM. Factors associated with molar-incisor hypomineralisation in schoolchildren aged 8-10 years: a case-control study. Int J Paediatr Dent. 2018 Nov;28(6):570-577. doi: 10.1111/ipd.12412. Epub 2018 Jul 17.
PubMed 30019508Cho SY, Ki Y, Chu V. Molar incisor hypomineralization in Hong Kong Chinese children. Int J Paediatr Dent. 2008 Sep;18(5):348-52. doi: 10.1111/j.1365-263X.2008.00927.x. Epub 2008 Jul 10.
PubMed 18637048Dietrich G, Sperling S, Hetzer G. Molar incisor hypomineralisation in a group of children and adolescents living in Dresden (Germany). Eur J Paediatr Dent. 2003 Sep;4(3):133-7.
PubMed 14529334Heitmuller D, Thiering E, Hoffmann U, Heinrich J, Manton D, Kuhnisch J, Neumann C, Bauer CP, Heinrich-Weltzien R, Hickel R; GINIplus Study Group. Is there a positive relationship between molar incisor hypomineralisations and the presence of dental caries? Int J Paediatr Dent. 2013 Mar;23(2):116-24. doi: 10.1111/j.1365-263X.2012.01233.x. Epub 2012 Mar 2.
PubMed 22384801Kuscu OO, Caglar E, Aslan S, Durmusoglu E, Karademir A, Sandalli N. The prevalence of molar incisor hypomineralization (MIH) in a group of children in a highly polluted urban region and a windfarm-green energy island. Int J Paediatr Dent. 2009 May;19(3):176-85. doi: 10.1111/j.1365-263X.2008.00945.x. Epub 2008 Nov 11.
PubMed 19016928Soviero V, Haubek D, Trindade C, Da Matta T, Poulsen S. Prevalence and distribution of demarcated opacities and their sequelae in permanent 1st molars and incisors in 7 to 13-year-old Brazilian children. Acta Odontol Scand. 2009;67(3):170-5. doi: 10.1080/00016350902758607.
PubMed 19253064Martos J, Gewehr A, Paim E. Aesthetic approach for anterior teeth with enamel hypoplasia. Contemp Clin Dent. 2012 Apr;3(Suppl 1):S82-5. doi: 10.4103/0976-237X.95112.
PubMed 22629075Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23.
PubMed 31808584Meyer-Lueckel H, Paris S, Kielbassa AM. Surface layer erosion of natural caries lesions with phosphoric and hydrochloric acid gels in preparation for resin infiltration. Caries Res. 2007;41(3):223-30. doi: 10.1159/000099323.
PubMed 17426404William V, Messer LB, Burrow MF. Molar incisor hypomineralization: review and recommendations for clinical management. Pediatr Dent. 2006 May-Jun;28(3):224-32.
PubMed 16805354Paris S, Meyer-Lueckel H, Kielbassa AM. Resin infiltration of natural caries lesions. J Dent Res. 2007 Jul;86(7):662-6. doi: 10.1177/154405910708600715.
PubMed 17586715
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Effect of Resin Infiltration Treatment on Hypomineralised Enamel Surfaces
- ClinicalTrials.gov ID
- NCT04685889
- Acronym / sponsor ID
- 2018/35
- Keywords
- molar incisor hypomineralisation, resin infiltration, discoloration, enamel, lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 23 May 2018 (actual)
- Primary completion
- 23 Jun 2018 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 28 Dec 2020 (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.
The investigators aimed to evaluate changes in mineralisation degree, colour, and size of the lesion after Icon® in permanent teeth with MIH in 6 months.
Detailed description
A total of 116 permanent central teeth of 37 patients were included in the study. Icon® was applied to teeth with MIH, while the healthy teeth received no treatment (control).
Group I : Icon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure.
Group II (Control Group): No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure.
Lesions were evaluated before, immediately after, and 1, 3, and 6 months after treatment. Mineralisation degree of MIH lesions was evaluated using DIAGNOdent Pen, changes in the lesion colour and lesion size were evaluated using VITA EasyShade and the cross polarization technique, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Icon Group | Active comparator | Procedure: Resin infiltrationIcon® resin infiltration treatment was performed on 58 permanent central teeth with MIH and evaluated before; immediately after; and 1, 3, and 6 months after the procedure. |
| Control Group | No intervention | –No treatment was performed on healthy teeth. However, similar to the treated teeth, 58 healthy permanent central teeth of the same individuals were evaluated before; immediately after; and 1, 3, and 6 months after the procedure. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Molar incisor hypomineralisation on the labial surface of permanent central teeth Least one of the labial surface of the permanent anterior teeth were affected by MIH.
Key exclusion criteria (5 listed)
- Dental caries and filling on anterior teeth.
- Dental anomaly on anterior teeth.
- Undergoing orthodontic treatment.
- Periodontal diseases.
- Cognitive and behavioural problems.
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 |
|---|---|---|
| Resin infiltrationA sufficient amount of HCl was applied to the lesion using the icon etch syringe included in the set and was allowed to sit for 2 minutes. After washing with water for 30 seconds, the tooth was dried using an air spray. Once the enamel surface appeared chalky, Icon® dry application was initiated. Ethanol was applied to the lesion using the Icon® dry syringe included in the set, and after 30 seconds it was dried using an air spray. Sufficient amount of resin infiltrant was applied to the lesion using the Icon® infiltrant syringe. The resin infiltrant was applied to the lesion surface by massaging with the tip of the syringe in circular movements for 3 minutes such that it penetrates the surface thoroughly. The resin infiltrant was polymerized for 40 seconds with a light device. | Procedure or surgery | Icon Group |
Primary outcome
Changes in the Mineralisation degree
Time frame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
MIH lesions was evaluated using DIAGNOdent Pen (laser fluorescence)
Changes in the lesion colour
Time frame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Changes in the MIH lesions colour was evaluated using VITA EasyShade (Spectrophotometers are equipped with sensors that can measure in many wavelengths)
Lesion size evaluated using cross polarization technique
Time frame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later
Changes in the MIH lesions size was evaluated using cross polarization technique
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 28 Dec 2020.
- Background: PubMed 11641576Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
- Background: PubMed 23351220Jeremias F, de Souza JF, Silva CM, Cordeiro Rde C, Zuanon AC, Santos-Pinto L. Dental caries experience and Molar-Incisor Hypomineralization. Acta Odontol Scand. 2013 May-Jul;71(3-4):870-6. doi: 10.3109/00016357.2012.734412. Epub 2013 Jan 28.
- Background: PubMed 11310241Jalevik B, Noren JG. Enamel hypomineralization of permanent first molars: a morphological study and survey of possible aetiological factors. Int J Paediatr Dent. 2000 Dec;10(4):278-89. doi: 10.1046/j.1365-263x.2000.00210.x.
- Background: PubMed 15153976Fearne J, Anderson P, Davis GR. 3D X-ray microscopic study of the extent of variations in enamel density in first permanent molars with idiopathic enamel hypomineralisation. Br Dent J. 2004 May 22;196(10):634-8; discussion 625. doi: 10.1038/sj.bdj.4811282.
- Background: PubMed 30019508Dantas-Neta NB, Soares Figueiredo M, Lima CCB, Bendo CB, Matos de Andrade EM, Lima MDM, Pordeus IA, Paiva SM. Factors associated with molar-incisor hypomineralisation in schoolchildren aged 8-10 years: a case-control study. Int J Paediatr Dent. 2018 Nov;28(6):570-577. doi: 10.1111/ipd.12412. Epub 2018 Jul 17.
- Background: PubMed 18637048Cho SY, Ki Y, Chu V. Molar incisor hypomineralization in Hong Kong Chinese children. Int J Paediatr Dent. 2008 Sep;18(5):348-52. doi: 10.1111/j.1365-263X.2008.00927.x. Epub 2008 Jul 10.
- Background: PubMed 14529334Dietrich G, Sperling S, Hetzer G. Molar incisor hypomineralisation in a group of children and adolescents living in Dresden (Germany). Eur J Paediatr Dent. 2003 Sep;4(3):133-7.
- Background: PubMed 22384801Heitmuller D, Thiering E, Hoffmann U, Heinrich J, Manton D, Kuhnisch J, Neumann C, Bauer CP, Heinrich-Weltzien R, Hickel R; GINIplus Study Group. Is there a positive relationship between molar incisor hypomineralisations and the presence of dental caries? Int J Paediatr Dent. 2013 Mar;23(2):116-24. doi: 10.1111/j.1365-263X.2012.01233.x. Epub 2012 Mar 2.
- Background: PubMed 19016928Kuscu OO, Caglar E, Aslan S, Durmusoglu E, Karademir A, Sandalli N. The prevalence of molar incisor hypomineralization (MIH) in a group of children in a highly polluted urban region and a windfarm-green energy island. Int J Paediatr Dent. 2009 May;19(3):176-85. doi: 10.1111/j.1365-263X.2008.00945.x. Epub 2008 Nov 11.
- Background: PubMed 19253064Soviero V, Haubek D, Trindade C, Da Matta T, Poulsen S. Prevalence and distribution of demarcated opacities and their sequelae in permanent 1st molars and incisors in 7 to 13-year-old Brazilian children. Acta Odontol Scand. 2009;67(3):170-5. doi: 10.1080/00016350902758607.
- Background: PubMed 22629075Martos J, Gewehr A, Paim E. Aesthetic approach for anterior teeth with enamel hypoplasia. Contemp Clin Dent. 2012 Apr;3(Suppl 1):S82-5. doi: 10.4103/0976-237X.95112.
- Background: PubMed 31808584Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23.
- 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.
Halenur Altan, assoc. prof. study director
Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
Rabia Erağca Yılmaz, Msc. Dt. principal investigator
Tokat Gaziosmanpaşa University, Faculty of Dentistry, Department of Pediatric Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration in people with Molar Incisor Hypomineralization and Enamel Hypoplasia, run by Tokat Gaziosmanpasa 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 1 inclusion and 5 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 28 Dec 2020. 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?
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?
Changes in the Mineralisation degree (time frame: Baseline (before resin infiltration), immediately after resin infiltration, 1 month later, 3 months later, 6 months later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685889, which also lists 28 linked publications.
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 28 Dec 2020.