Molar Incisor HypomineralizationNCT04209920
A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From MIH
A study testing CAD-CAM milled PMMA crown and Cast metal coping using nickel chromium alloy in people with Molar Incisor Hypomineralization, run by Ain Shams University at 1 site in Egypt.
Trial summary
It is a randomized clinical trial in which two different types of full coverage restoration in used to restore hypomineralized first permanent molar and protect the remaining tooth structure in patients with molar incisor hypomineralization ,one group is covered with CAD-CAM milled poly methyl methacrylate crowns and… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- CAD-CAM milled PMMA crown and Cast metal coping using nickel chromium alloy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Apr 2021
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient with molar incisor hypomineralization having at least one permanent fist molar affected and indicated for full coverage.
- Patient is healthy and medically free.
- Patient's age range from 6 to 12 years old.
- The molar is free from any symptoms of pulp inflammation or has reversible pulpitis (Hypersensitivity).
Who cannot join
- Patient who has any chronic systemic disease or immunocompromised.
- Patient with special health care needs.
- Molar which has irreversible pulpitis or pulp necrosis.
- Molar which has periapical radiolucency and/or abscess or fistula or any periapical pathosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From Molar Incisor Hypomineralization (MIH)" (Randomized Clinical Trial)
It is a randomized clinical trial in which two different types of full coverage restoration in used to restore hypomineralized first permanent molar and protect the remaining tooth structure in patients with molar incisor hypomineralization ,one group is covered with CAD-CAM milled poly methyl methacrylate crowns and the other group is covered with cast metal copings (CAC) using nickel chromium alloy and there will be a nine months follow up.
Read the detailed description
STUDY POPULATION Sixty (60) hypomineralized molars in patients suffering from molar incisor hypomineralization (MIH) will be randomly selected to share in this study from the out-patient clinic of pedodontics department, Faculty of dentistry, Ain Shams University.
Patient's approval :
All patients and parents will be informed in details about the nature of the investigation and the purpose of the study. They will agree to take part in the study and the parent will sign an informed consent form and the child will have an assent form.
All reasonable steps to protect the security of the personal information and privacy of the patient protected health information will be taken.
All patients will be notice about their privacy practices, their legal duties and their rights.
All patients will be informed about their benefits from research that will be obtaining a restoration to restore and protect the hypomineralized first permanent molars.
Patient's history:
Precise medical, dental and family histories will be taken from all patients through a direct interview and diagnostic sheet.
Parent will be asked about all the possible causes that might cause the molar incisor hypomineralizaion since pregnancy and during the first three years of his life (prenatal, perinatal and postnatal).
Patient's Examination:
- Extra-oral examination: it will be performed following routine procedures to detect any facial abnormality, temporomandibular joint abnormality, any sign of inflammation, pathology or any soft or hard tissue abnormalities.
- Intra oral examination: it will be performed following routine procedures to examine the sound and affected teeth, soft tissue swelling or fistulae, the occlusion and occlusal relation and proximal contacts, the periodontal status and any other anomalies.
Radiographic Evaluation:
Panoramic and peri-apical radiograph for the molar which is indicated to be included on the trial will be taken to the patients preoperatively to evaluate the pulp status, the supporting bone and to ensure that the patients are free from any pathological lesions and to evaluate the position and development of the second permanent molars.
Patient's Grouping:
Selected patients will be randomly divided into two groups:
- Group (I): patients will receive CAD-CAM milled PMMA crown.
- Group (II): patients will receive cast metal coping using nickel chromium alloy.
STUDY PROCEDURE
Clinical steps:
Half of the molars will receive CAD-CAM milled PMMA crown and the other half will receive cast adhesive metal coping using nickel chromium alloy randomly.
- After proper intraoral and radiographic examination impression of upper and lower arches was made for fabrication of temporary crowns to protect the teeth till fabrication of crowns are finished and the crowns are delivered to the patient.
- Behavior management of the patient, preparation and administration of local anesthesia is done.
- Preparation For PMMA crowns Removal of any caries associated to the molar and then reduction of the molar (1mm) all round the molar and (1.5mm) occlusally and impression is taken for upper and lower jaws after reduction for crown fabrication. For Cast Adhesive Coping (CAC) Removal of any caries associated to the molar and then reduction of the molar (0.5: 0.7 mm) all round the molar and (1: 1.5mm) occlusally and impression is taken for upper and lower jaws after reduction for crown fabrication.
- Temporary crown are fabricated and cemented using zinc oxide and eugenol.
- Delivery and Cementation For PMMA crown After crown is fabricated, the tooth is cleaned, dried and isolated and cementation is done using Self Etch Resin Cement. For Cast Adhesive Coping (CAC) After crown is fabricated, the tooth is cleaned and dried and then etched for 30 seconds and then washed and dried to give chalky white appearance, and then the crown is cemented using dual composite cement.
- Evaluation of quality of both crowns is checked by patient's satisfaction, comfort and function, proper occlusion and proximal contact, margins of the crowns and coverage of all surfaces adequately.
- The patient will be instructed to maintain good oral hygiene and to avoid eating sticky food.
Then the patient will have 1, 3, 6 and 9 months follow up to evaluate the crowns by clinical examination to evaluate margins and clinical performance of the crowns and gingival hygiene, and bitewing radio graph to evaluate margins of the crowns and any recurrent caries, and questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort then data is collected and recorded.
The study is expected to be done in 12 months.
STATISTICAL ANALYSIS A proper statistical method will be carried out to compare between CAD-CAM milled PolyMethyl Methacrylate (PMMA) and Cast adhesive metal coping (CAC) for management of extensive first permanent molar defects in patients suffering from MIH.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- CAD-CAM milled PMMA crown, Cast metal coping using nickel chromium alloy
- Keywords
- Molar Incisor Hypomineralization, MIH, Hypomineralized, First permanent molar, Molar defects, PMMA, cast adhesive coping
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD-CAM milled PMMA crownDevice
the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using PMMA disks using a CAD-CAM technology.
Cast metal coping using nickel chromium alloyOther
the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using Nickel Chromium alloy to make a Cast Coping.
| Study group | Role | What they receive |
|---|---|---|
| PMMA crown Group | Active comparator | Hypomineralized first permanent molars in patients with molar incisor hypomineralization. Receives: Device: CAD-CAM milled PMMA crown |
| Cast metal coping Group | Active comparator | Hypomineralized first permanent molars in patients with molar incisor hypomineralization. Receives: Other: Cast metal coping using nickel chromium alloy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Integrity
the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.
Measured: 9 months follow up
Related quality of life: questionnaire
A questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort.
Measured: 9 months
Recurrent caries
the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.
Measured: 9 months
Gingival Health
the gingival health around the crown is evaluated using Gingival Index (GI) by a periodontal probe and clinical sign of inflammation .
Measured: 9 months
longevity
longevity of the crown is measured by the presence of the crown in the oral cavity cemented and sound.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Mar 2019
- Primary completion1 Jan 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Mahmoud Mohie, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209920
- Sponsor's protocol ID
- PED 18- 1M
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2019
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From Molar Incisor Hypomineralization (MIH)" (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04209920
- Acronym / sponsor ID
- PED 18- 1M
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor Hypomineralization, MIH, Hypomineralized, First permanent molar, Molar defects, PMMA, cast adhesive coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 24 Dec 2019 (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.
It is a randomized clinical trial in which two different types of full coverage restoration in used to restore hypomineralized first permanent molar and protect the remaining tooth structure in patients with molar incisor hypomineralization ,one group is covered with CAD-CAM milled poly methyl methacrylate crowns and the other group is covered with cast metal copings (CAC) using nickel chromium alloy and there will be a nine months follow up.
Detailed description
STUDY POPULATION Sixty (60) hypomineralized molars in patients suffering from molar incisor hypomineralization (MIH) will be randomly selected to share in this study from the out-patient clinic of pedodontics department, Faculty of dentistry, Ain Shams University.
Patient's approval :
All patients and parents will be informed in details about the nature of the investigation and the purpose of the study. They will agree to take part in the study and the parent will sign an informed consent form and the child will have an assent form.
All reasonable steps to protect the security of the personal information and privacy of the patient protected health information will be taken.
All patients will be notice about their privacy practices, their legal duties and their rights.
All patients will be informed about their benefits from research that will be obtaining a restoration to restore and protect the hypomineralized first permanent molars.
Patient's history:
Precise medical, dental and family histories will be taken from all patients through a direct interview and diagnostic sheet.
Parent will be asked about all the possible causes that might cause the molar incisor hypomineralizaion since pregnancy and during the first three years of his life (prenatal, perinatal and postnatal).
Patient's Examination:
- Extra-oral examination: it will be performed following routine procedures to detect any facial abnormality, temporomandibular joint abnormality, any sign of inflammation, pathology or any soft or hard tissue abnormalities.
- Intra oral examination: it will be performed following routine procedures to examine the sound and affected teeth, soft tissue swelling or fistulae, the occlusion and occlusal relation and proximal contacts, the periodontal status and any other anomalies.
Radiographic Evaluation:
Panoramic and peri-apical radiograph for the molar which is indicated to be included on the trial will be taken to the patients preoperatively to evaluate the pulp status, the supporting bone and to ensure that the patients are free from any pathological lesions and to evaluate the position and development of the second permanent molars.
Patient's Grouping:
Selected patients will be randomly divided into two groups:
- Group (I): patients will receive CAD-CAM milled PMMA crown.
- Group (II): patients will receive cast metal coping using nickel chromium alloy.
STUDY PROCEDURE
Clinical steps:
Half of the molars will receive CAD-CAM milled PMMA crown and the other half will receive cast adhesive metal coping using nickel chromium alloy randomly.
- After proper intraoral and radiographic examination impression of upper and lower arches was made for fabrication of temporary crowns to protect the teeth till fabrication of crowns are finished and the crowns are delivered to the patient.
- Behavior management of the patient, preparation and administration of local anesthesia is done.
- Preparation For PMMA crowns Removal of any caries associated to the molar and then reduction of the molar (1mm) all round the molar and (1.5mm) occlusally and impression is taken for upper and lower jaws after reduction for crown fabrication. For Cast Adhesive Coping (CAC) Removal of any caries associated to the molar and then reduction of the molar (0.5: 0.7 mm) all round the molar and (1: 1.5mm) occlusally and impression is taken for upper and lower jaws after reduction for crown fabrication.
- Temporary crown are fabricated and cemented using zinc oxide and eugenol.
- Delivery and Cementation For PMMA crown After crown is fabricated, the tooth is cleaned, dried and isolated and cementation is done using Self Etch Resin Cement. For Cast Adhesive Coping (CAC) After crown is fabricated, the tooth is cleaned and dried and then etched for 30 seconds and then washed and dried to give chalky white appearance, and then the crown is cemented using dual composite cement.
- Evaluation of quality of both crowns is checked by patient's satisfaction, comfort and function, proper occlusion and proximal contact, margins of the crowns and coverage of all surfaces adequately.
- The patient will be instructed to maintain good oral hygiene and to avoid eating sticky food.
Then the patient will have 1, 3, 6 and 9 months follow up to evaluate the crowns by clinical examination to evaluate margins and clinical performance of the crowns and gingival hygiene, and bitewing radio graph to evaluate margins of the crowns and any recurrent caries, and questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort then data is collected and recorded.
The study is expected to be done in 12 months.
STATISTICAL ANALYSIS A proper statistical method will be carried out to compare between CAD-CAM milled PolyMethyl Methacrylate (PMMA) and Cast adhesive metal coping (CAC) for management of extensive first permanent molar defects in patients suffering from MIH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMMA crown Group | Active comparator | Device: CAD-CAM milled PMMA crownHypomineralized first permanent molars in patients with molar incisor hypomineralization. |
| Cast metal coping Group | Active comparator | Other: Cast metal coping using nickel chromium alloyHypomineralized first permanent molars in patients with molar incisor hypomineralization. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient with molar incisor hypomineralization having at least one permanent fist molar affected and indicated for full coverage.
- Patient is healthy and medically free.
- Patient's age range from 6 to 12 years old.
- The molar is free from any symptoms of pulp inflammation or has reversible pulpitis (Hypersensitivity).
Key exclusion criteria (4 listed)
- Patient who has any chronic systemic disease or immunocompromised.
- Patient with special health care needs.
- Molar which has irreversible pulpitis or pulp necrosis.
- Molar which has periapical radiolucency and/or abscess or fistula or any periapical pathosis.
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 |
|---|---|---|
| CAD-CAM milled PMMA crownthe patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using PMMA disks using a CAD-CAM technology. | Device | PMMA crown Group |
| Cast metal coping using nickel chromium alloythe patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using Nickel Chromium alloy to make a Cast Coping. | Other | Cast metal coping Group |
Primary outcome
Marginal Integrity
Time frame: 9 months follow up
the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.
Related quality of life: questionnaire
Time frame: 9 months
A questionnaire about related quality of life of the patient to evaluate patient's satisfaction and comfort.
Recurrent caries
Time frame: 9 months
the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.
Gingival Health
Time frame: 9 months
the gingival health around the crown is evaluated using Gingival Index (GI) by a periodontal probe and clinical sign of inflammation .
longevity
Time frame: 9 months
longevity of the crown is measured by the presence of the crown in the oral cavity cemented and sound.
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 7 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAD-CAM milled PMMA crown and Cast metal coping using nickel chromium alloy in people with Molar Incisor Hypomineralization, run by Ain Shams University 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 4 inclusion and 4 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 7 Sep 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 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?
Marginal Integrity (time frame: 9 months follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2023.