Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812690
Status:
COMPLETED
Last Update Posted:
2023-04-20
First Post:
2023-03-31
Brief Title:
Molar Incisor Hypomineralisation and Dental Anomalies
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
An International Study of Molar Incisor Hypomineralisation and Its Association With Dental Anomalies
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Backgroundstudy aim
Molar incisor hypomineralisation MIH is a common disorder of tooth development Affected teeth have weak enamel and adult molars often require extensive treatment or even extraction A preliminary study carried out in Sheffield Dental Hospital discovered that 12 of MIH children also had congenitally missing adult teeth presenting further challenges to treatment-planning This novel finding stimulated discussion between international MIH experts whilst some clinicians had observed this association others had not Therefore the primary aim of this international study is to determine the association between MIH and missing teeth in different populations This has important clinical and biological relevance in understanding the presentation and management of MIH
Participantsresearch sites
This study will include 584 children with MIH and a comparison group of 584 children without MIH Young dental patients aged 7-16 years who attend for a check-up or treatment at one of the 15 participating countries will be invited to take part The UK sites are Sheffield Newcastle and University College London Dental Hospitals and all children will be seen by specialistsconsultants in paediatric dentistry to confirm their diagnosis of MIH The main inclusion criteria is that children have a dental xray as part of their routine care
Data collection
Following a routine dental check-up we will grade the severity of the participants MIH if present and record any other dental anomalies eg abnormal tooth number position or shape We will also check the dental xray for other anomalies that cannot be seen from the clinical exam We will analyse the prevalence of MIH and association with other dental anomalies to see if there are difference according to sex or ethnicity and compare our findings with the non-MIH group We anticipate the study will take 18 months
Molar incisor hypomineralisation MIH is a common disorder of tooth development Affected teeth have weak enamel and adult molars often require extensive treatment or even extraction A preliminary study carried out in Sheffield Dental Hospital discovered that 12 of MIH children also had congenitally missing adult teeth presenting further challenges to treatment-planning This novel finding stimulated discussion between international MIH experts whilst some clinicians had observed this association others had not Therefore the primary aim of this international study is to determine the association between MIH and missing teeth in different populations This has important clinical and biological relevance in understanding the presentation and management of MIH
Participantsresearch sites
This study will include 584 children with MIH and a comparison group of 584 children without MIH Young dental patients aged 7-16 years who attend for a check-up or treatment at one of the 15 participating countries will be invited to take part The UK sites are Sheffield Newcastle and University College London Dental Hospitals and all children will be seen by specialistsconsultants in paediatric dentistry to confirm their diagnosis of MIH The main inclusion criteria is that children have a dental xray as part of their routine care
Data collection
Following a routine dental check-up we will grade the severity of the participants MIH if present and record any other dental anomalies eg abnormal tooth number position or shape We will also check the dental xray for other anomalies that cannot be seen from the clinical exam We will analyse the prevalence of MIH and association with other dental anomalies to see if there are difference according to sex or ethnicity and compare our findings with the non-MIH group We anticipate the study will take 18 months
Detailed Description:
The primary objective is to compare the overall prevalence of congenitally missing teethhypodontia excluding wisdom teeth in children 7-16 years old with and without MIH
Secondary research questionsobjectives
The secondary research objectives are to
1 Compare the prevalence of developmentally missing teeth hypodontia in MIH children based on region ethnicity and gender
2 Determine the clinical pattern including symmetry severity and treatment need of MIH in children aged 7-16years referred to specialist paediatric dentistry services across the world according to gender and ethnic groupregion
3 Compare the prevalence of other co-existing developmental dental anomalies between the two groups
4 Compare the prevalence of developing third permanent molars between the two groups
What is the scientific justification for the research
Molar incisor hypomineralisation MIH is one of the most common disorders of tooth development seen in paediatric dentistry practice around the world A recent meta-analysis of 99 studies in 43 different countries estimated the global prevalence of MIH to be 131 with significant variations seen between super-regions regions and countries
A wide variety of other dental anomalies are also seen in childhood broadly encompassing deviations in tooth number morphology structure position and eruption Prevalence data for all these different developmental disorders vary widely depending on the anomaly in question diagnostic approach and the target population It is also important to note that the presence of one anomaly should always alert clinicians to the possibility of others as numerous studies have demonstrated significant inter-relationships between certain anomaly types Recently a UK study explored for the first time the prevalence of dental anomalies in children diagnosed with MIH Clinical and radiographic examination of 101 children aged 6-15 years found that in total 29 of patients had another dental anomaly in addition to MIH Walshaw et al 2020
There are established guidelines for the management of children with MIH In some situations the extraction of one or more first permanent molars is the preferred option providing all other permanent teeth and preferably third permanent molarswisdom teeth are present Thus the congenital absence of a second premolar in the same quadrant would have considerable impact on this decision and potentially compromises long-term outcomes A controlled study exploring any association between the presence of MIH and hypodontia in addition to other dental anomalies is clearly warranted to better inform patient management The need for earlier radiographic examination and definitive treatment for hypomineralised first permanent molars would be paramount if such an association is confirmed by the proposed multi-centre international study
Design and methodology
This will be a cross-sectional study involving children with MIH and a comparison group of non MIH-affected children
Burden to research participants Research participants MIH and comparison group will not be required to attend any additional visits other than their scheduled check-up or treatment visit However their dental check up will take slightly longer than normal around an extra 5 minutes as we will be recording in more detail than usual the condition of their enamel using a validated scoring system of MIH They will have a dental xray taken as part of their routine care so will not be exposed to unnecessary ionising radiation They will also be invited to have clinical photographs of their teeth which may not have been part of their routine care They will also be verbally asked two validated questions about how they rate their own oral health which is not part of routine care
Study population
Participants will be recruited from patients attending for treatment a recall or new patient assessment in the host centres Written informed consent will be obtained for study participation from parentsguardians and children The experimental group will be children aged 7-16 years referred to specialist paediatric dentistry services for the management of MIH in the following countries
1 Nigeria
2 Australia-2 centres both Melbourne
3 Chile
4 Egypt
5 India
6 Jordan
7 Netherlands- 2 centres
8 New Zealand
9 Qatar
10 Singapore
11 South Sudan
12 United Kingdom- 3 centres London Newcastle Sheffield
13 United States of America
14 United Arab Emirates
15 Saudi Arabia
A sample size of 1168 children 584 per group was calculated In order to achieve this sample size each centre will aim to recruit 84 participants 42 patients per MIH group and 42 patients per control group
Examiner training and calibration
Examiner training and calibration will be conducted on-line using Microsoft Teams using a set of ten clinical images and radiographs to ensure that there is acceptable intra-and inter-examiner agreement for key parameters under investigation as follows
Use of a validated MIH index to record severity status for first permanent molars
Clinical and radiographic diagnosis of all dental anomalies abnormal tooth size position and shape
Presenceabsence of developing third permanent molars wisdom teeth
Degree of taurodontism this is an abnormal root canal shape in lower first permanent molars using established criteriaindex All clinicians involved in recording these parameters will have to reach acceptable levels of repeatability
Examination and data collection An electronic data collection form will be developed and piloted prior to commencement of the main study The following non-identifiable patient and clinical variables will be recorded prior to transfer to a shared electronic dataset using secure processes
Demographics
Age
Sex
Ethnicity
Primary dental diagnosis for both MIH and control participants
Childrens global assessment of their own oral health status Radiographic characteristics All participants must have a full panoral dental radiograph of good diagnostic quality taken for routine care A record will be made of any abnormalities of tooth shape number and position from the radiographic presentation
Assessment of taurodontism abnormal root canal shape For patients with mature apical development of their first permanent mandibular molars 10 years and over an objective assessment of taurodontism will be carried out using digital measurements from panoral dental radiographs This will be done according to established protocols in brief a diagnosis of taurodontism will be made if the crownroot ratio of the tooth is 11 indicating that the crown pulp shape is abnormally elongated compared to the root length
Data entry and statistical analysis
Each unit will be responsible for anonymised electronic data entry for their participants and will send the complete data set securely to the principal investigators for data analysis
Simple descriptive analysis will be used to present the demographic clinical and radiographic findings for the MIH and control groups In addition statistical tests will be applied to determine
Any significant difference in the prevalence of dental anomalies notably congenitally missing teeth between children with and without a diagnosis of MIH and according to gender and ethnicity
Any significant difference in the prevalencedegree of taurodontism abnormal root canal shape between children with and without a diagnosis of MIH and according to gender and ethnicity
Any significant associations between the severity of MIH and presence of developing wisdom teeth taurodontism and dental anomalies according to gender and ethnicity
Secondary research questionsobjectives
The secondary research objectives are to
1 Compare the prevalence of developmentally missing teeth hypodontia in MIH children based on region ethnicity and gender
2 Determine the clinical pattern including symmetry severity and treatment need of MIH in children aged 7-16years referred to specialist paediatric dentistry services across the world according to gender and ethnic groupregion
3 Compare the prevalence of other co-existing developmental dental anomalies between the two groups
4 Compare the prevalence of developing third permanent molars between the two groups
What is the scientific justification for the research
Molar incisor hypomineralisation MIH is one of the most common disorders of tooth development seen in paediatric dentistry practice around the world A recent meta-analysis of 99 studies in 43 different countries estimated the global prevalence of MIH to be 131 with significant variations seen between super-regions regions and countries
A wide variety of other dental anomalies are also seen in childhood broadly encompassing deviations in tooth number morphology structure position and eruption Prevalence data for all these different developmental disorders vary widely depending on the anomaly in question diagnostic approach and the target population It is also important to note that the presence of one anomaly should always alert clinicians to the possibility of others as numerous studies have demonstrated significant inter-relationships between certain anomaly types Recently a UK study explored for the first time the prevalence of dental anomalies in children diagnosed with MIH Clinical and radiographic examination of 101 children aged 6-15 years found that in total 29 of patients had another dental anomaly in addition to MIH Walshaw et al 2020
There are established guidelines for the management of children with MIH In some situations the extraction of one or more first permanent molars is the preferred option providing all other permanent teeth and preferably third permanent molarswisdom teeth are present Thus the congenital absence of a second premolar in the same quadrant would have considerable impact on this decision and potentially compromises long-term outcomes A controlled study exploring any association between the presence of MIH and hypodontia in addition to other dental anomalies is clearly warranted to better inform patient management The need for earlier radiographic examination and definitive treatment for hypomineralised first permanent molars would be paramount if such an association is confirmed by the proposed multi-centre international study
Design and methodology
This will be a cross-sectional study involving children with MIH and a comparison group of non MIH-affected children
Burden to research participants Research participants MIH and comparison group will not be required to attend any additional visits other than their scheduled check-up or treatment visit However their dental check up will take slightly longer than normal around an extra 5 minutes as we will be recording in more detail than usual the condition of their enamel using a validated scoring system of MIH They will have a dental xray taken as part of their routine care so will not be exposed to unnecessary ionising radiation They will also be invited to have clinical photographs of their teeth which may not have been part of their routine care They will also be verbally asked two validated questions about how they rate their own oral health which is not part of routine care
Study population
Participants will be recruited from patients attending for treatment a recall or new patient assessment in the host centres Written informed consent will be obtained for study participation from parentsguardians and children The experimental group will be children aged 7-16 years referred to specialist paediatric dentistry services for the management of MIH in the following countries
1 Nigeria
2 Australia-2 centres both Melbourne
3 Chile
4 Egypt
5 India
6 Jordan
7 Netherlands- 2 centres
8 New Zealand
9 Qatar
10 Singapore
11 South Sudan
12 United Kingdom- 3 centres London Newcastle Sheffield
13 United States of America
14 United Arab Emirates
15 Saudi Arabia
A sample size of 1168 children 584 per group was calculated In order to achieve this sample size each centre will aim to recruit 84 participants 42 patients per MIH group and 42 patients per control group
Examiner training and calibration
Examiner training and calibration will be conducted on-line using Microsoft Teams using a set of ten clinical images and radiographs to ensure that there is acceptable intra-and inter-examiner agreement for key parameters under investigation as follows
Use of a validated MIH index to record severity status for first permanent molars
Clinical and radiographic diagnosis of all dental anomalies abnormal tooth size position and shape
Presenceabsence of developing third permanent molars wisdom teeth
Degree of taurodontism this is an abnormal root canal shape in lower first permanent molars using established criteriaindex All clinicians involved in recording these parameters will have to reach acceptable levels of repeatability
Examination and data collection An electronic data collection form will be developed and piloted prior to commencement of the main study The following non-identifiable patient and clinical variables will be recorded prior to transfer to a shared electronic dataset using secure processes
Demographics
Age
Sex
Ethnicity
Primary dental diagnosis for both MIH and control participants
Childrens global assessment of their own oral health status Radiographic characteristics All participants must have a full panoral dental radiograph of good diagnostic quality taken for routine care A record will be made of any abnormalities of tooth shape number and position from the radiographic presentation
Assessment of taurodontism abnormal root canal shape For patients with mature apical development of their first permanent mandibular molars 10 years and over an objective assessment of taurodontism will be carried out using digital measurements from panoral dental radiographs This will be done according to established protocols in brief a diagnosis of taurodontism will be made if the crownroot ratio of the tooth is 11 indicating that the crown pulp shape is abnormally elongated compared to the root length
Data entry and statistical analysis
Each unit will be responsible for anonymised electronic data entry for their participants and will send the complete data set securely to the principal investigators for data analysis
Simple descriptive analysis will be used to present the demographic clinical and radiographic findings for the MIH and control groups In addition statistical tests will be applied to determine
Any significant difference in the prevalence of dental anomalies notably congenitally missing teeth between children with and without a diagnosis of MIH and according to gender and ethnicity
Any significant difference in the prevalencedegree of taurodontism abnormal root canal shape between children with and without a diagnosis of MIH and according to gender and ethnicity
Any significant associations between the severity of MIH and presence of developing wisdom teeth taurodontism and dental anomalies according to gender and ethnicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None