Molar Incisor HypomineralizationNCT04471571
Resin Infiltration Treatment Versus a Combined Treatment With Microabrasion for the Management of MIH Affected Incisors
A study testing Resin infiltration and microabrasion for MIH-affected incisors and Resin infiltration for MIH-affected incisors in people with Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
The prevalence of molar incisor hypomineralization is relatively high. It has been reported that MIH-affected children experience a wide range of negative impacts because of having visible enamel opacities on their incisors whether these teeth show post eruptive breakdown or not. Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Resin infiltration and microabrasion for MIH-affected incisors and Resin infiltration for MIH-affected incisors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jun 2022
- 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 7 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Cooperative children aged between 7-16 years old
- Children with MIH having enamel opacity involving at least one permanent incisor
- MIH- affected incisors which did not receive any previous treatment
- 1/3 of the crown should be visible in the oral cavity
- Lesions size should be more than 1mm
- Healthy children
Who cannot join
- Children with systemic diseases, allergies or any dental or facial anomaly other than MIH
- Children aged < 7 or > 16 years old
- Uncooperative children
- MIH patients without the affection of the incisors or with compromised incisor esthetics due to tooth surface loss, traumatic dental injury or caries
- MIH incisors which already received any kind of treatment
- Lesions which are smaller than 1mm in size
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparison of the Effectiveness of Resin Infiltration Treatment Versus a Combined Treatment of Microabrasion and Resin Infiltration for the Management of Affected Incisors in Molar Incisor Hypomineralization (MIH) Cases
The prevalence of molar incisor hypomineralization is relatively high. It has been reported that MIH-affected children experience a wide range of negative impacts because of having visible enamel opacities on their incisors whether these teeth show post eruptive breakdown or not. The management of MIH is challenging with a broad spectrum of treatment modalities being available. However, there are no clear guidelines available to aid in clinical decision making. Possible treatment options for anterior teeth with MIH include: Microabrasion, resin infiltration, tooth bleaching, etch-bleach and seal technique and composite restorations or veneers. It is believed that these methods could be used alone or in a combination of methods to achieve better aesthetic results.
For MIH affected-incisors microabrasion and resin infiltration are acceptable treatment options which could be used alone or in a combination. Accordingly, the aim of this study is to compare the clinical outcomes of using resin infiltration either alone or combined with microabrasion for the management of MIH affected incisors.
Read the detailed description
The study will be conducted on a dental unit in postgraduate clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.The primary hypothesis of this study is that a resin infiltration and microabrasion combined treatment will result in better clinical outcomes than using resin infiltration alone. All treatment procedures will be carried out by the principal investigator.
36 patients will be included in the study. The teeth will be randomized into two groups according to the intervention. The study involves two types of interventions:
Group 1 (resin infiltration):
The treatment will follow the manufacturer's instructions (Icon, DMG, Hamburg, Germany). The procedure involves the application of Icon-Etch, Icon-Dry as well as Icon-Infiltrant. Followed by removal of excess and then polishing of the treated surfaces.
Group 2 (Micro-abrasion followed by resin infiltration):
The Micro-abrasion agent (Opalustre, Ultradent, South Jordan, UT, USA) will be applied to the tooth for 60 seconds using a standard rubber cup attached to a low speed hand piece followed by rinsing the tooth surface with water for 20 seconds. This procedure will be repeated up to 5 times.
Resin infiltration will then be carried out as discussed before.
Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the masking color of the teeth selected in the study.
Measurements will be taken before, immediately after, 1 month, 3 months, 6 months and 12 months after treatment.
A standardized Photograph will be taken at 5 different times (before treatment, immediately afterwards, one month, 6 months and 12 months after treatment with the exact same camera and conditions. The images collected will be analyzed and evaluated by 2 different dentists.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Resin infiltration and microabrasion for MIH-affected incisors, Resin infiltration for MIH-affected incisors
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltration and microabrasion for MIH-affected incisorsOther
MIH-affected incisors will be treated with microabrasion followed by resin infiltration as a combined treatment
Resin infiltration for MIH-affected incisorsOther
MIH-affected incisors will be treated with resin infiltration alone
| Study group | Role | What they receive |
|---|---|---|
| Resin infiltration group | Active comparator | Enamel lesions for this group will be treated only by resin infiltration. Receives: Other: Resin infiltration for MIH-affected incisors |
| Microabrasion + resin infiltration group | Experimental | Enamel lesions for this group will be treated first by microabrasion followed by resin infiltration. Receives: Other: Resin infiltration and microabrasion for MIH-affected incisors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the aesthetics and amount of color masking of the lesion
Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L*, a*, and b* values will be recorded for each tooth based on the CIEL*a* b* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=[(∆L*)2+(∆a*)2+(∆b*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.
Measured: 12 months
Secondary outcomes (1)
Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14
It includes evaluating the patient's Oral Health Related Quality of life (OHRQoL) before and after treatment which is measured as difference in the scores of the Child Perceptions Questionnaire CPQ 8-10/11-14 before and after treatment. There are 36 items included in the questionnaire covering four different domains: oral symptoms, function related limitations as well as emotional and social well-being. The participants should answer regarding the frequency of certain events in the last six months. There are 5 responses to choose from: 0 = Never, 1 = Once or twice, 2 = Sometimes, 3 = Often and 4 = Every day or almost every day. The total score should range from 0 to 144. Higher scores indicate low oral health related quality of life (OHRQoL).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- two-arm parallel group randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Shehab, Cairo University
- Investigators
- Shehab El-Din, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471571
- Sponsor's protocol ID
- DShehab
- Status last verified
- Jul 2020
- First submitted
- 2 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Almuallem Z, Busuttil-Naudi A. Molar incisor hypomineralisation (MIH) - an overview. Br Dent J. 2018 Oct 5. doi: 10.1038/sj.bdj.2018.814. Online ahead of print.
PubMed 30287963Hasmun N, Lawson J, Vettore MV, Elcock C, Zaitoun H, Rodd H. Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment for Children with Molar Incisor Hypomineralisation: A Prospective Study. Dent J (Basel). 2018 Nov 1;6(4):61. doi: 10.3390/dj6040061.
PubMed 30388743
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Resin Infiltration Treatment Versus a Combined Treatment of Microabrasion and Resin Infiltration for the Management of Affected Incisors in Molar Incisor Hypomineralization (MIH) Cases
- ClinicalTrials.gov ID
- NCT04471571
- Acronym / sponsor ID
- DShehab
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 15 Jul 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 prevalence of molar incisor hypomineralization is relatively high. It has been reported that MIH-affected children experience a wide range of negative impacts because of having visible enamel opacities on their incisors whether these teeth show post eruptive breakdown or not. The management of MIH is challenging with a broad spectrum of treatment modalities being available. However, there are no clear guidelines available to aid in clinical decision making. Possible treatment options for anterior teeth with MIH include: Microabrasion, resin infiltration, tooth bleaching, etch-bleach and seal technique and composite restorations or veneers. It is believed that these methods could be used alone or in a combination of methods to achieve better aesthetic results.
For MIH affected-incisors microabrasion and resin infiltration are acceptable treatment options which could be used alone or in a combination. Accordingly, the aim of this study is to compare the clinical outcomes of using resin infiltration either alone or combined with microabrasion for the management of MIH affected incisors.
Detailed description
The study will be conducted on a dental unit in postgraduate clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.The primary hypothesis of this study is that a resin infiltration and microabrasion combined treatment will result in better clinical outcomes than using resin infiltration alone. All treatment procedures will be carried out by the principal investigator.
36 patients will be included in the study. The teeth will be randomized into two groups according to the intervention. The study involves two types of interventions:
Group 1 (resin infiltration):
The treatment will follow the manufacturer's instructions (Icon, DMG, Hamburg, Germany). The procedure involves the application of Icon-Etch, Icon-Dry as well as Icon-Infiltrant. Followed by removal of excess and then polishing of the treated surfaces.
Group 2 (Micro-abrasion followed by resin infiltration):
The Micro-abrasion agent (Opalustre, Ultradent, South Jordan, UT, USA) will be applied to the tooth for 60 seconds using a standard rubber cup attached to a low speed hand piece followed by rinsing the tooth surface with water for 20 seconds. This procedure will be repeated up to 5 times.
Resin infiltration will then be carried out as discussed before.
Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the masking color of the teeth selected in the study.
Measurements will be taken before, immediately after, 1 month, 3 months, 6 months and 12 months after treatment.
A standardized Photograph will be taken at 5 different times (before treatment, immediately afterwards, one month, 6 months and 12 months after treatment with the exact same camera and conditions. The images collected will be analyzed and evaluated by 2 different dentists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- two-arm parallel group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Resin infiltration group | Active comparator | Other: Resin infiltration for MIH-affected incisorsEnamel lesions for this group will be treated only by resin infiltration. |
| Microabrasion + resin infiltration group | Experimental | Other: Resin infiltration and microabrasion for MIH-affected incisorsEnamel lesions for this group will be treated first by microabrasion followed by resin infiltration. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Cooperative children aged between 7-16 years old
- Children with MIH having enamel opacity involving at least one permanent incisor
- MIH- affected incisors which did not receive any previous treatment
- 1/3 of the crown should be visible in the oral cavity
- Lesions size should be more than 1mm
Key exclusion criteria (6 listed)
- Children with systemic diseases, allergies or any dental or facial anomaly other than MIH
- Children aged < 7 or > 16 years old
- Uncooperative children
- MIH patients without the affection of the incisors or with compromised incisor esthetics due to tooth surface loss, traumatic dental injury or caries
- MIH incisors which already received any kind of treatment
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 infiltration and microabrasion for MIH-affected incisorsMIH-affected incisors will be treated with microabrasion followed by resin infiltration as a combined treatment | Other | Microabrasion + resin infiltration group |
| Resin infiltration for MIH-affected incisorsMIH-affected incisors will be treated with resin infiltration alone | Other | Resin infiltration group |
Primary outcome
Change in the aesthetics and amount of color masking of the lesion
Time frame: 12 months
Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L*, a*, and b* values will be recorded for each tooth based on the CIEL*a* b* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=[(∆L*)2+(∆a*)2+(∆b*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.
1 secondary outcome
Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 30287963Almuallem Z, Busuttil-Naudi A. Molar incisor hypomineralisation (MIH) - an overview. Br Dent J. 2018 Oct 5. doi: 10.1038/sj.bdj.2018.814. Online ahead of print.
- Background: PubMed 30388743Hasmun N, Lawson J, Vettore MV, Elcock C, Zaitoun H, Rodd H. Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment for Children with Molar Incisor Hypomineralisation: A Prospective Study. Dent J (Basel). 2018 Nov 1;6(4):61. doi: 10.3390/dj6040061.
- 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.
Shehab El-Din principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration and microabrasion for MIH-affected incisors and Resin infiltration for MIH-affected incisors in people with Molar Incisor Hypomineralization, run by Cairo 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 6 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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shehab El-Din (201066695543, dinanasrshehab@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the aesthetics and amount of color masking of the lesion (time frame: 12 months). 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 NCT04471571, which also lists 2 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 15 Jul 2020.