Molar Incisor HypomineralizationNCT05727475
Change in OHRQOL Following Minimally Invasive Treatment of Anterior Teeth in Children With MIH
A study testing Minimal invasive restorative treatment and Fluoride gel application in people with Molar Incisor Hypomineralization, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
MIH is a prevalent developmental defect which has a negative impact on children's OHRQoL, especially when incisor opacities are present. The aim of this study is to evaluate the change in OHRQoL following minimally invasive aesthetic treatment of anterior permanent teeth opacities in children with MIH using the Arabic… Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Minimal invasive restorative treatment and Fluoride gel application
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteJordan
- Study dates
- 12 Nov 2021to 1 Jun 2023
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with MIH and who have a visible enamel opacity involving at least one anterior permanent tooth;
- Children who request improvement in their anterior permanent teeth aesthetics.
Who cannot join
- Children who have an acute dental symptom and require urgent treatment;
- Children who need to undergo active treatment for their hypomineralized molars during the proposed study period (e.g., extractions) or orthodontic treatment;
- Children with any dental or facial anomaly other than MIH;
- Children with compromised incisor aesthetics due to a traumatic dental injury (crown fracture), tooth surface loss, or caries;
- Children with MIH and who do not have a visible enamel opacity involving at least one anterior permanent tooth; and
- Children with poor behavior.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment of Anterior Teeth in Children With Molar Incisor Hypomineralization: A Prospective Clinical Study.
MIH is a prevalent developmental defect which has a negative impact on children's OHRQoL, especially when incisor opacities are present. The aim of this study is to evaluate the change in OHRQoL following minimally invasive aesthetic treatment of anterior permanent teeth opacities in children with MIH using the Arabic C-OHIP-SF19 as a data collection tool.
This RCT will be conducted on children with MIH (n=156), aged 6-16 years, at the Post Graduate (PG) clinics, Jordan University of Science and Technology (Irbid). Patients will be randomly assigned in to two groups: Study group (n=78), with anterior teeth composite facing done to mask the opacity, and control group (n=78) where fluoride gel application was done. Children will be assessed by filling the COHIP-SF19 questionnaire before and one-month after the treatment to evaluate OHRQoL changes.
Read the detailed description
Background: Molar Incisor Hypomineralization (MIH) is defined as a hypomineralized lesion of the enamel as a result of different causes, mainly affecting permanent first molars and frequently associated to similar lesions (that appear as opacities) on upper and/or lower permanent incisors, causing deterioration and destruction of affected teeth because the enamel is fragile, and depending on the severity, may cause teeth to be lost.
Aim: The aim of this clinical study is to evaluate the change in oral health-related quality of life following minimally invasive aesthetic treatment of anterior permanent teeth in children with molar incisor hypomineralization using the Arabic C-OHIP-SF19 as a data collection tool.
Methods: This will be a prospective clinical study which will be performed on a group of school-children with MIH at the Post Graduate (PG) clinics, Jordan University of Science and Technology (JUST), ages 6-16 years. A total of 156 children with MIH and anterior permanent teeth opacities, requesting cosmetic improvement of one or more anterior permanent teeth will be offered a composite facing. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment. The patients will be divided into 2 groups (78 participants per group): Group 1: Restorative group (study group); in this group, a composite facing will be placed on the anterior incisors to mask the opacity. Minimal invasive treatment will be done without drilling or removal of enamel, unless there is caries, which will be removed in this case, and Group 2: Fluoride gel group (control group); in this group, fluoride gel application will be done for all teeth using 1.23% APF gel delivered through a foam tray. In this group, if the child is not happy with the appearance after fluoride gel application, a composite facing will be offered.
Expected results: We expect that MIH patients who undergo the minimally invasive composite facing for the anterior teeth in order to reduce the visibility of enamel opacities to have a higher score on the C-OHIP-SF19 questionnaire because the esthetic treatment can have a positive impact on the children's wellbeing.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Minimal invasive restorative treatment, Fluoride gel application
- Keywords
- Minimally invasive, Esthetic treatment, Oral health related quality of life, C-OHIP-SF19, Composite veneer
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive restorative treatmentProcedure or surgery
Composite veneer facing without drilling or removal of enamel
Fluoride gel applicationProcedure or surgery
Fluoride gel application 1.23%
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | In this group, a composite facing will be placed on the anterior incisors to mask the opacity. Minimal invasive treatment will be done without drilling or removal of enamel. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment. Receives: Procedure: Minimal invasive restorative treatment |
| Control group | Active comparator | In this group, fluoride gel application will be done for all teeth using 1.23% APF gel delivered through a foam tray. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment.
After filling the C-OHIP-SF19 questionnaire 1 month post treatment, if the child is not happy with the appearance after fluoride gel application, a composite facing will be offered. Receives: Procedure: Fluoride gel application |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHRQoL changes
Changes OHRQoL before and after the intervention and the difference between both groups (group 1 and 2).
Measured: After 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start12 Nov 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Ola B. Al-Batayneh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727475
- Sponsor's protocol ID
- 556-2021
- Status last verified
- Nov 2023
- First submitted
- 5 Feb 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Americano GC, Jacobsen PE, Soviero VM, Haubek D. A systematic review on the association between molar incisor hypomineralization and dental caries. Int J Paediatr Dent. 2017 Jan;27(1):11-21. doi: 10.1111/ipd.12233. Epub 2016 Apr 21.
PubMed 27098755Arheiam AA, Baker SR, Ballo L, Elareibi I, Fakron S, Harris RV. The development and psychometric properties of the Arabic version of the child oral health impact profile-short form (COHIP- SF 19). Health Qual Life Outcomes. 2017 Nov 13;15(1):218. doi: 10.1186/s12955-017-0796-4.
PubMed 29132377Broder HL, Wilson-Genderson M, Sischo L. Reliability and validity testing for the Child Oral Health Impact Profile-Reduced (COHIP-SF 19). J Public Health Dent. 2012 Fall;72(4):302-12. doi: 10.1111/j.1752-7325.2012.00338.x. Epub 2012 Apr 27.
PubMed 22536873da Costa-Silva CM, Jeremias F, de Souza JF, Cordeiro Rde C, Santos-Pinto L, Zuanon AC. Molar incisor hypomineralization: prevalence, severity and clinical consequences in Brazilian children. Int J Paediatr Dent. 2010 Nov;20(6):426-34. doi: 10.1111/j.1365-263X.2010.01097.x. Epub 2010 Aug 24.
PubMed 20738434Hasmun 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 30388743Hasmun N, Vettore MV, Lawson JA, Elcock C, Zaitoun H, Rodd HD. Determinants of children's oral health-related quality of life following aesthetic treatment of enamel opacities. J Dent. 2020 Jul;98:103372. doi: 10.1016/j.jdent.2020.103372. Epub 2020 May 11.
PubMed 32437856Minamidate T, Haruyama N, Takahashi I. The development, validation, and psychometric properties of the Japanese version of the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) for school-age children. Health Qual Life Outcomes. 2020 Jul 11;18(1):224. doi: 10.1186/s12955-020-01469-y.
PubMed 32653004Oyedele TA, Folayan MO, Adekoya-Sofowora CA, Oziegbe EO. Co-morbidities associated with molar-incisor hypomineralisation in 8 to 16 year old pupils in Ile-Ife, Nigeria. BMC Oral Health. 2015 Mar 13;15:37. doi: 10.1186/s12903-015-0017-7.
PubMed 25887347Schwendicke F, Elhennawy K, Reda S, Bekes K, Manton DJ, Krois J. Global burden of molar incisor hypomineralization. J Dent. 2018 Jan;68:10-18. doi: 10.1016/j.jdent.2017.12.002. Epub 2017 Dec 6.
PubMed 29221956Sischo L, Broder HL. Oral health-related quality of life: what, why, how, and future implications. J Dent Res. 2011 Nov;90(11):1264-70. doi: 10.1177/0022034511399918. Epub 2011 Mar 21.
PubMed 21422477Weerheijm KL, Duggal M, Mejare I, Papagiannoulis L, Koch G, Martens LC, Hallonsten AL. Judgement criteria for molar incisor hypomineralisation (MIH) in epidemiologic studies: a summary of the European meeting on MIH held in Athens, 2003. Eur J Paediatr Dent. 2003 Sep;4(3):110-3.
PubMed 14529329William V, Messer LB, Burrow MF. Molar incisor hypomineralization: review and recommendations for clinical management. Pediatr Dent. 2006 May-Jun;28(3):224-32.
PubMed 16805354Zawaideh FI, Al-Jundi SH, Al-Jaljoli MH. Molar incisor hypomineralisation: prevalence in Jordanian children and clinical characteristics. Eur Arch Paediatr Dent. 2011 Feb;12(1):31-6. doi: 10.1007/BF03262776.
PubMed 21299943
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment of Anterior Teeth in Children With Molar Incisor Hypomineralization: A Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT05727475
- Acronym / sponsor ID
- 556-2021
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Minimally invasive, Esthetic treatment, Oral health related quality of life, C-OHIP-SF19, Composite veneer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 14 Feb 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.
MIH is a prevalent developmental defect which has a negative impact on children's OHRQoL, especially when incisor opacities are present. The aim of this study is to evaluate the change in OHRQoL following minimally invasive aesthetic treatment of anterior permanent teeth opacities in children with MIH using the Arabic C-OHIP-SF19 as a data collection tool.
This RCT will be conducted on children with MIH (n=156), aged 6-16 years, at the Post Graduate (PG) clinics, Jordan University of Science and Technology (Irbid). Patients will be randomly assigned in to two groups: Study group (n=78), with anterior teeth composite facing done to mask the opacity, and control group (n=78) where fluoride gel application was done. Children will be assessed by filling the COHIP-SF19 questionnaire before and one-month after the treatment to evaluate OHRQoL changes.
Detailed description
Background: Molar Incisor Hypomineralization (MIH) is defined as a hypomineralized lesion of the enamel as a result of different causes, mainly affecting permanent first molars and frequently associated to similar lesions (that appear as opacities) on upper and/or lower permanent incisors, causing deterioration and destruction of affected teeth because the enamel is fragile, and depending on the severity, may cause teeth to be lost.
Aim: The aim of this clinical study is to evaluate the change in oral health-related quality of life following minimally invasive aesthetic treatment of anterior permanent teeth in children with molar incisor hypomineralization using the Arabic C-OHIP-SF19 as a data collection tool.
Methods: This will be a prospective clinical study which will be performed on a group of school-children with MIH at the Post Graduate (PG) clinics, Jordan University of Science and Technology (JUST), ages 6-16 years. A total of 156 children with MIH and anterior permanent teeth opacities, requesting cosmetic improvement of one or more anterior permanent teeth will be offered a composite facing. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment. The patients will be divided into 2 groups (78 participants per group): Group 1: Restorative group (study group); in this group, a composite facing will be placed on the anterior incisors to mask the opacity. Minimal invasive treatment will be done without drilling or removal of enamel, unless there is caries, which will be removed in this case, and Group 2: Fluoride gel group (control group); in this group, fluoride gel application will be done for all teeth using 1.23% APF gel delivered through a foam tray. In this group, if the child is not happy with the appearance after fluoride gel application, a composite facing will be offered.
Expected results: We expect that MIH patients who undergo the minimally invasive composite facing for the anterior teeth in order to reduce the visibility of enamel opacities to have a higher score on the C-OHIP-SF19 questionnaire because the esthetic treatment can have a positive impact on the children's wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Minimal invasive restorative treatmentIn this group, a composite facing will be placed on the anterior incisors to mask the opacity. Minimal invasive treatment will be done without drilling or removal of enamel. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment. |
| Control group | Active comparator | Procedure: Fluoride gel applicationIn this group, fluoride gel application will be done for all teeth using 1.23% APF gel delivered through a foam tray. They will be asked to fill in the Child Oral Health Impact Profile-Short Form (C-OHIP-SF19) questionnaire pre and 1 month post treatment. After filling the C-OHIP-SF19 questionnaire 1 month post treatment, if the child is not happy with the appearance after fluoride gel application, a composite facing will be offered. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with MIH and who have a visible enamel opacity involving at least one anterior permanent tooth;
- Children who request improvement in their anterior permanent teeth aesthetics.
Key exclusion criteria (6 listed)
- Children who have an acute dental symptom and require urgent treatment;
- Children who need to undergo active treatment for their hypomineralized molars during the proposed study period (e.g., extractions) or orthodontic treatment;
- Children with any dental or facial anomaly other than MIH;
- Children with compromised incisor aesthetics due to a traumatic dental injury (crown fracture), tooth surface loss, or caries;
- Children with MIH and who do not have a visible enamel opacity involving at least one anterior permanent tooth; and
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 |
|---|---|---|
| Minimal invasive restorative treatmentComposite veneer facing without drilling or removal of enamel | Procedure or surgery | Study group |
| Fluoride gel applicationFluoride gel application 1.23% | Procedure or surgery | Control group |
Primary outcome
OHRQoL changes
Time frame: After 1 year
Changes OHRQoL before and after the intervention and the difference between both groups (group 1 and 2).
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 14 Nov 2023.
- Background: PubMed 27098755Americano GC, Jacobsen PE, Soviero VM, Haubek D. A systematic review on the association between molar incisor hypomineralization and dental caries. Int J Paediatr Dent. 2017 Jan;27(1):11-21. doi: 10.1111/ipd.12233. Epub 2016 Apr 21.
- Background: PubMed 29132377Arheiam AA, Baker SR, Ballo L, Elareibi I, Fakron S, Harris RV. The development and psychometric properties of the Arabic version of the child oral health impact profile-short form (COHIP- SF 19). Health Qual Life Outcomes. 2017 Nov 13;15(1):218. doi: 10.1186/s12955-017-0796-4.
- Background: PubMed 22536873Broder HL, Wilson-Genderson M, Sischo L. Reliability and validity testing for the Child Oral Health Impact Profile-Reduced (COHIP-SF 19). J Public Health Dent. 2012 Fall;72(4):302-12. doi: 10.1111/j.1752-7325.2012.00338.x. Epub 2012 Apr 27.
- Background: PubMed 20738434da Costa-Silva CM, Jeremias F, de Souza JF, Cordeiro Rde C, Santos-Pinto L, Zuanon AC. Molar incisor hypomineralization: prevalence, severity and clinical consequences in Brazilian children. Int J Paediatr Dent. 2010 Nov;20(6):426-34. doi: 10.1111/j.1365-263X.2010.01097.x. Epub 2010 Aug 24.
- 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.
- Background: PubMed 32437856Hasmun N, Vettore MV, Lawson JA, Elcock C, Zaitoun H, Rodd HD. Determinants of children's oral health-related quality of life following aesthetic treatment of enamel opacities. J Dent. 2020 Jul;98:103372. doi: 10.1016/j.jdent.2020.103372. Epub 2020 May 11.
- Background: PubMed 32653004Minamidate T, Haruyama N, Takahashi I. The development, validation, and psychometric properties of the Japanese version of the Child Oral Health Impact Profile-Short Form 19 (COHIP-SF 19) for school-age children. Health Qual Life Outcomes. 2020 Jul 11;18(1):224. doi: 10.1186/s12955-020-01469-y.
- Background: PubMed 25887347Oyedele TA, Folayan MO, Adekoya-Sofowora CA, Oziegbe EO. Co-morbidities associated with molar-incisor hypomineralisation in 8 to 16 year old pupils in Ile-Ife, Nigeria. BMC Oral Health. 2015 Mar 13;15:37. doi: 10.1186/s12903-015-0017-7.
- Background: PubMed 29221956Schwendicke F, Elhennawy K, Reda S, Bekes K, Manton DJ, Krois J. Global burden of molar incisor hypomineralization. J Dent. 2018 Jan;68:10-18. doi: 10.1016/j.jdent.2017.12.002. Epub 2017 Dec 6.
- Background: PubMed 21422477Sischo L, Broder HL. Oral health-related quality of life: what, why, how, and future implications. J Dent Res. 2011 Nov;90(11):1264-70. doi: 10.1177/0022034511399918. Epub 2011 Mar 21.
- Background: PubMed 14529329Weerheijm KL, Duggal M, Mejare I, Papagiannoulis L, Koch G, Martens LC, Hallonsten AL. Judgement criteria for molar incisor hypomineralisation (MIH) in epidemiologic studies: a summary of the European meeting on MIH held in Athens, 2003. Eur J Paediatr Dent. 2003 Sep;4(3):110-3.
- Background: PubMed 16805354William V, Messer LB, Burrow MF. Molar incisor hypomineralization: review and recommendations for clinical management. Pediatr Dent. 2006 May-Jun;28(3):224-32.
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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.
Ola B. Al-Batayneh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal invasive restorative treatment and Fluoride gel application in people with Molar Incisor Hypomineralization, run by King Abdullah University Hospital at 1 site in Jordan.
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 2 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: finished, as of the sponsor's last update on 14 Nov 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 Jordan. 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?
OHRQoL changes (time frame: After 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 NCT05727475, which also lists 13 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 14 Nov 2023.