Molar Incisor HypomineralizationMIHNCT04231019
Knowledge of Egyptian Dental Practitioners Regarding Molar-Incisor Hypomineralization
An observational study of Molar Incisor Hypomineralization and Dental Enamel Hypoplasia, run by Alaa Mohammed Yehia at 1 site in Egypt.
Trial summary
Molar incisor hypomineralization (MIH) is one of the developmental enamel defect which is characterized by demarcated, qualitative defects of enamel of systemic origin affecting one to four first permanent molars (FPMs) and frequently associated with incisor involvement. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization, Dental Enamel Hypoplasia
- What is being tested?
- self-administered questionnaire
- How many people
- 800 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Sep 2018to 23 Dec 2019
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Fifth year dental students, general dental practitioners and dental specialists.
Who may be able to join
- Males and females.
- Dental students should be at the fifth year.
- All participants should be Egyptians.
Who cannot join
- Dentists or dental students who refuse to participate in the study.
- Any dentist without the Egyptian nationality even if they are studying in Egyptian universities or working in Egypt.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Knowledge, Awareness and Perception Regarding Molar-Incisor Hypomineralization Among General Dental Practitioners, Dental Specialists and Dental Students in Egypt"
Molar incisor hypomineralization (MIH) is one of the developmental enamel defect which is characterized by demarcated, qualitative defects of enamel of systemic origin affecting one to four first permanent molars (FPMs) and frequently associated with incisor involvement. Similar lesions can be seen in second primary molars and their presence has been reported as a predictive factor for developing MIH. Although the exact etiology of MIH is unclear, it is likely to be multi-factorial. Possible etiological factors of MIH are systemic conditions as pneumonia, upper respiratory tract infections, asthma, otitis media, hypoxia, high fever, hypocalcemia and exposure to antibiotics as amoxicillin.
The prevalence of MIH has been reported from several studies to be between 2.8 and 40.2 %, with the mean approximately 15 %. MIH is considered as a common clinical problem by several epidemiological studies from many countries.
Clinical presentation of MIH can include white, creamy and yellow-brown opacities, irregular areas of post eruptive breakdown, which can be mistaken diagnosed as hypoplasia or atypical caries. The condition is usually associated with a high disease burden, leading to pain, infection and tooth loss. Teeth affected by MIH are at high risk of rapid caries development and progression, rapid wear and enamel breakdown. Severely affected enamel disintegrates under masticatory forces resulting in post-eruptive breakdown (PEB), which is also a characteristic feature of MIH-affected teeth. These teeth require treatment, ranging from prevention to restorations and extractions, often under general anesthesia. A multidisciplinary cooperation among clinicians is often required, particularly for extractions of first permanent molars, when orthodontic consequences need to be considered. To evaluate the effect of this condition, questionnaires of dentists and dental professionals have been carried out in various countries, including those in Europe, Australia and New Zealand, Malaysia, Iraq, Iran and Saudi Arabian. These have generally revealed that MIH has been frequently encountered in clinical practice, particularly by dental professionals who treat children and that there is a need for further training for the condition. To date dental clinicians' concerns regarding MIH have not been extensively assessed in Egypt.
Read the detailed description
In 1970, this condition has been first described as a hypomineralization of the permanent first molars (PFMs) but was consistently referred to it as non-fluoride hypomineralization.
In 2000, there were four presentations that described the same types of developmental defects of dental enamel affecting the first permanent molars (FPM) at the European Academy of Pediatric Dentistry Congress. These reports called the condition hypomineralized first permenet molars FPM, idiopathic enamel hypomineralization in FPM, non-fluoride hypomineralisation in FPM and cheese molars. This was not a new condition. It had been recognized previously but the congress focused on the fact that it has multiple names and that this could conceivably lead to confusion.
In 2001, it has been desirable to use one name that has no reference to any possible etiological factor. So the term "molar-incisor hypomineralization" (MIH) was adopted by Weerheijm to describe these developmental defects and he gave it a definition as "hypomineralization of systemic origin of 1-4 FPM, frequently associated with affected incisors".
In 2003, it was suggested that any examination for MIH should be undertaken on clean wet teeth and optimum at the age of 8-years, as at this age all permanent first molars(PFMs) and most of the incisors will have erupted. The MIH diagnostic criteria are defined using the modified defect of dental enamel (DDE) index, based on criteria by Weerheijm.
Degree of MIH severity Modified DDE index (FDI 1992) Mild degree:- 30% of enamel surface area affected by MIH Moderate degree:- 31 - 49% of enamel surface area affected by MIH Severe degree:- 50% of enamel surface area affected by MIH
Definitions of the criteria used for diagnosing MIH
- Opacity:-A defect involving an alteration in the translucency of the enamel. The defective enamel is of normal thickness at the time of tooth eruption with a smooth surface and white, yellow or brown color. The borders of the lesions are demarcated.
- PEB (post eruptive enamel breakdown):- The defect is indicating deficiency of the surface after eruption of the tooth. This may be caused by such factors as masticatory forces, attrition and trauma (physiological or pathological).
- Atypical Restoration (iatrogenic factor):-Size and shape of restoration do not conform to typical restorative characteristics. In most cases, restorations will be extensive (involving buccal or palatal smooth surface). At the border of the restoration, opacity may be noticed.
- Extraction due to MIH:- Absence of the first permanent molar in a sound dentition is suspected to have been an MIH condition (should take detailed past history, clinical examination of other first permanent molars and incisors).
Many studies have been done to single out a specific etiology for MIH. In 2006, A review by William stated that although an etiology is not known at this time, children who had poor general health in their first three years of life, who were preterm born (low birth weight infants) or were exposed to certain environmental contaminants may be at risk for MIH.
The majority of prevalence and severity studies of MIH to date have taken place in Europe. In 2003, Weerheijm and Mejàre attempted to map its occurrence throughout Europe using a questionnaire sent to members of the European Academy of Pediatric Dentistry.
In 2008, Crombie carried out a questionnaire to assess knowledge of members of the Australian and New Zealand Society of Pediatric Dentistry and found that MIH was widely recognized.
In 2011, a survey mainly about prevalence and etiology of MIH was carried out among teaching staff across all specialties in one dental college in Iraq by Ghanim.
In 2014, two surveys were published investigating the knowledge of Iranian and Malaysian dentists on the etiology, prevalence and management of MIH by Bagheri, Hussein .
In 2014, A study conducted in Jeddah, Saudi Arabia found a prevalence of MIH of 8.6 % by Allazzam and In 2015, another study about the knowledge of Saudi Arabian dental practitioners and students was done by M. J. Silva.
In 2015, A survey was done to estimate the knowledge of pediatric dentists and general dental practitioners in UK.
In 2016, A study on knowledge of Australian and Chilean public oral health care practitioners was done.
The aim of the study is to assess the knowledge of Egyptian dental practitioners regarding the prevalence, etiology, diagnosis and the management of Molar Incisor Hypomineralization (MIH)
- Being tested
- self-administered questionnaire
- Keywords
- Molar incisor hypomineralization, General dental practitioners, Perception, knowledge, Oral health
- 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.
self-administered questionnaireOther
Self-administered questionnaires with plain language statements and brief description of the clinical features and photographs of MIH were used to determine the knowledge, awareness and perception regarding the prevalence, severity, etiology and treatment modalities of molar-incisor hypomineralization (MIH) among Egyptian fifth year dental students, general dental practitioners and dental specialists.
There were two routes for delivering the questionnaire either as online questionnaire sent to the participants by email or as a hard copy that is hand delivered.
| Study group | Role | What they receive |
|---|---|---|
| Dental practitioners (general, specialists or students) | Two self-administered questionnaires will be used in the study one to general practitioners and specialists and another one with a plain language describing the study will be distributed to the fifth year dental students in Egypt with total 1000 dentist to assess their knowledge, awareness and perception regarding MIH. Receives: Other: self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge of Egyptian dental practitioners regarding molar-incisor hypomineralization
The tool used for measuring the primary outcome is a self-administered questionnaire that was fulfilled by the study participants
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start16 Sep 2018
- Primary completion22 Oct 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Mohammed Yehia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mohammed Yehia, Ain Shams University
- Investigators
- Alaa Mo Yehia, Ass. Lec, Principal investigator, Faculty of Dentistry- Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231019
- Sponsor's protocol ID
- DPH 18-1M
- Acronym
- MIH
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2019
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Silva MJ, Alhowaish L, Ghanim A, Manton DJ. Knowledge and attitudes regarding molar incisor hypomineralisation amongst Saudi Arabian dental practitioners and dental students. Eur Arch Paediatr Dent. 2016 Aug;17(4):215-22. doi: 10.1007/s40368-016-0230-3. Epub 2016 May 12.
PubMed 27172776Silva MJ, Scurrah KJ, Craig JM, Manton DJ, Kilpatrick N. Etiology of molar incisor hypomineralization - A systematic review. Community Dent Oral Epidemiol. 2016 Aug;44(4):342-53. doi: 10.1111/cdoe.12229. Epub 2016 Apr 28.
PubMed 27121068Hussein AS, Ghanim AM, Abu-Hassan MI, Manton DJ. Knowledge, management and perceived barriers to treatment of molar-incisor hypomineralisation in general dental practitioners and dental nurses in Malaysia. Eur Arch Paediatr Dent. 2014 Oct;15(5):301-7. doi: 10.1007/s40368-014-0115-2. Epub 2014 Feb 26.
PubMed 24569938Ghanim A, Morgan M, Marino R, Manton D, Bailey D. Perception of molar-incisor hypomineralisation (MIH) by Iraqi dental academics. Int J Paediatr Dent. 2011 Jul;21(4):261-70. doi: 10.1111/j.1365-263X.2011.01118.x. Epub 2011 Feb 20.
PubMed 21332851
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Knowledge, Awareness and Perception Regarding Molar-Incisor Hypomineralization Among General Dental Practitioners, Dental Specialists and Dental Students in Egypt"
- ClinicalTrials.gov ID
- NCT04231019
- Acronym / sponsor ID
- MIH / DPH 18-1M
- Keywords
- Molar incisor hypomineralization, General dental practitioners, Perception, knowledge, Oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Alaa Mohammed YehiaUniversity, hospital or other
- Study start
- 16 Sep 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 18 Jan 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.
Molar incisor hypomineralization (MIH) is one of the developmental enamel defect which is characterized by demarcated, qualitative defects of enamel of systemic origin affecting one to four first permanent molars (FPMs) and frequently associated with incisor involvement. Similar lesions can be seen in second primary molars and their presence has been reported as a predictive factor for developing MIH. Although the exact etiology of MIH is unclear, it is likely to be multi-factorial. Possible etiological factors of MIH are systemic conditions as pneumonia, upper respiratory tract infections, asthma, otitis media, hypoxia, high fever, hypocalcemia and exposure to antibiotics as amoxicillin.
The prevalence of MIH has been reported from several studies to be between 2.8 and 40.2 %, with the mean approximately 15 %. MIH is considered as a common clinical problem by several epidemiological studies from many countries.
Clinical presentation of MIH can include white, creamy and yellow-brown opacities, irregular areas of post eruptive breakdown, which can be mistaken diagnosed as hypoplasia or atypical caries. The condition is usually associated with a high disease burden, leading to pain, infection and tooth loss. Teeth affected by MIH are at high risk of rapid caries development and progression, rapid wear and enamel breakdown. Severely affected enamel disintegrates under masticatory forces resulting in post-eruptive breakdown (PEB), which is also a characteristic feature of MIH-affected teeth. These teeth require treatment, ranging from prevention to restorations and extractions, often under general anesthesia. A multidisciplinary cooperation among clinicians is often required, particularly for extractions of first permanent molars, when orthodontic consequences need to be considered. To evaluate the effect of this condition, questionnaires of dentists and dental professionals have been carried out in various countries, including those in Europe, Australia and New Zealand, Malaysia, Iraq, Iran and Saudi Arabian. These have generally revealed that MIH has been frequently encountered in clinical practice, particularly by dental professionals who treat children and that there is a need for further training for the condition. To date dental clinicians' concerns regarding MIH have not been extensively assessed in Egypt.
Detailed description
In 1970, this condition has been first described as a hypomineralization of the permanent first molars (PFMs) but was consistently referred to it as non-fluoride hypomineralization.
In 2000, there were four presentations that described the same types of developmental defects of dental enamel affecting the first permanent molars (FPM) at the European Academy of Pediatric Dentistry Congress. These reports called the condition hypomineralized first permenet molars FPM, idiopathic enamel hypomineralization in FPM, non-fluoride hypomineralisation in FPM and cheese molars. This was not a new condition. It had been recognized previously but the congress focused on the fact that it has multiple names and that this could conceivably lead to confusion.
In 2001, it has been desirable to use one name that has no reference to any possible etiological factor. So the term "molar-incisor hypomineralization" (MIH) was adopted by Weerheijm to describe these developmental defects and he gave it a definition as "hypomineralization of systemic origin of 1-4 FPM, frequently associated with affected incisors".
In 2003, it was suggested that any examination for MIH should be undertaken on clean wet teeth and optimum at the age of 8-years, as at this age all permanent first molars(PFMs) and most of the incisors will have erupted. The MIH diagnostic criteria are defined using the modified defect of dental enamel (DDE) index, based on criteria by Weerheijm.
Degree of MIH severity Modified DDE index (FDI 1992) Mild degree:- 30% of enamel surface area affected by MIH Moderate degree:- 31 - 49% of enamel surface area affected by MIH Severe degree:- 50% of enamel surface area affected by MIH
Definitions of the criteria used for diagnosing MIH
- Opacity:-A defect involving an alteration in the translucency of the enamel. The defective enamel is of normal thickness at the time of tooth eruption with a smooth surface and white, yellow or brown color. The borders of the lesions are demarcated.
- PEB (post eruptive enamel breakdown):- The defect is indicating deficiency of the surface after eruption of the tooth. This may be caused by such factors as masticatory forces, attrition and trauma (physiological or pathological).
- Atypical Restoration (iatrogenic factor):-Size and shape of restoration do not conform to typical restorative characteristics. In most cases, restorations will be extensive (involving buccal or palatal smooth surface). At the border of the restoration, opacity may be noticed.
- Extraction due to MIH:- Absence of the first permanent molar in a sound dentition is suspected to have been an MIH condition (should take detailed past history, clinical examination of other first permanent molars and incisors).
Many studies have been done to single out a specific etiology for MIH. In 2006, A review by William stated that although an etiology is not known at this time, children who had poor general health in their first three years of life, who were preterm born (low birth weight infants) or were exposed to certain environmental contaminants may be at risk for MIH.
The majority of prevalence and severity studies of MIH to date have taken place in Europe. In 2003, Weerheijm and Mejàre attempted to map its occurrence throughout Europe using a questionnaire sent to members of the European Academy of Pediatric Dentistry.
In 2008, Crombie carried out a questionnaire to assess knowledge of members of the Australian and New Zealand Society of Pediatric Dentistry and found that MIH was widely recognized.
In 2011, a survey mainly about prevalence and etiology of MIH was carried out among teaching staff across all specialties in one dental college in Iraq by Ghanim.
In 2014, two surveys were published investigating the knowledge of Iranian and Malaysian dentists on the etiology, prevalence and management of MIH by Bagheri, Hussein .
In 2014, A study conducted in Jeddah, Saudi Arabia found a prevalence of MIH of 8.6 % by Allazzam and In 2015, another study about the knowledge of Saudi Arabian dental practitioners and students was done by M. J. Silva.
In 2015, A survey was done to estimate the knowledge of pediatric dentists and general dental practitioners in UK.
In 2016, A study on knowledge of Australian and Chilean public oral health care practitioners was done.
The aim of the study is to assess the knowledge of Egyptian dental practitioners regarding the prevalence, etiology, diagnosis and the management of Molar Incisor Hypomineralization (MIH)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental practitioners (general, specialists or students) | – | Other: self-administered questionnaireTwo self-administered questionnaires will be used in the study one to general practitioners and specialists and another one with a plain language describing the study will be distributed to the fifth year dental students in Egypt with total 1000 dentist to assess their knowledge, awareness and perception regarding MIH. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Fifth year dental students, general dental practitioners and dental specialists.
Key inclusion criteria (3 listed)
- Males and females.
- Dental students should be at the fifth year.
- All participants should be Egyptians.
Key exclusion criteria (2 listed)
- Dentists or dental students who refuse to participate in the study.
- Any dentist without the Egyptian nationality even if they are studying in Egyptian universities or working in Egypt.
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 |
|---|---|---|
| self-administered questionnaireSelf-administered questionnaires with plain language statements and brief description of the clinical features and photographs of MIH were used to determine the knowledge, awareness and perception regarding the prevalence, severity, etiology and treatment modalities of molar-incisor hypomineralization (MIH) among Egyptian fifth year dental students, general dental practitioners and dental specialists. There were two routes for delivering the questionnaire either as online questionnaire sent to the participants by email or as a hard copy that is hand delivered. | Other | Dental practitioners (general, specialists or students) |
Primary outcome
knowledge of Egyptian dental practitioners regarding molar-incisor hypomineralization
Time frame: 1 year
The tool used for measuring the primary outcome is a self-administered questionnaire that was fulfilled by the study participants
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 31 Jan 2024.
- Background: PubMed 27172776Silva MJ, Alhowaish L, Ghanim A, Manton DJ. Knowledge and attitudes regarding molar incisor hypomineralisation amongst Saudi Arabian dental practitioners and dental students. Eur Arch Paediatr Dent. 2016 Aug;17(4):215-22. doi: 10.1007/s40368-016-0230-3. Epub 2016 May 12.
- Background: PubMed 27121068Silva MJ, Scurrah KJ, Craig JM, Manton DJ, Kilpatrick N. Etiology of molar incisor hypomineralization - A systematic review. Community Dent Oral Epidemiol. 2016 Aug;44(4):342-53. doi: 10.1111/cdoe.12229. Epub 2016 Apr 28.
- Background: PubMed 24569938Hussein AS, Ghanim AM, Abu-Hassan MI, Manton DJ. Knowledge, management and perceived barriers to treatment of molar-incisor hypomineralisation in general dental practitioners and dental nurses in Malaysia. Eur Arch Paediatr Dent. 2014 Oct;15(5):301-7. doi: 10.1007/s40368-014-0115-2. Epub 2014 Feb 26.
- Background: PubMed 21332851Ghanim A, Morgan M, Marino R, Manton D, Bailey D. Perception of molar-incisor hypomineralisation (MIH) by Iraqi dental academics. Int J Paediatr Dent. 2011 Jul;21(4):261-70. doi: 10.1111/j.1365-263X.2011.01118.x. Epub 2011 Feb 20.
- Individual participant dataSharing planned: Undecided
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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.
Alaa Mo Yehia, Ass. Lec principal investigator
Faculty of Dentistry- Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Molar Incisor Hypomineralization and Dental Enamel Hypoplasia, run by Alaa Mohammed Yehia at 1 site in Egypt.
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 3 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 31 Jan 2024. 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 Egypt. 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?
knowledge of Egyptian dental practitioners regarding molar-incisor hypomineralization (time frame: 1 year). 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 NCT04231019, which also lists 4 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 31 Jan 2024.