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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Ain Shams University

    Cairo

Other trials in Egypt

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.

  1. 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.
  2. Behavior management of the patient, preparation and administration of local anesthesia is done.
  3. 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.
  4. Temporary crown are fabricated and cemented using zinc oxide and eugenol.
  5. 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.
  6. 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.
  7. 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.

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 groups in NCT04209920
Study groupRoleWhat they receive
PMMA crown GroupActive comparatorHypomineralized first permanent molars in patients with molar incisor hypomineralization.
Receives: Device: CAD-CAM milled PMMA crown
Cast metal coping GroupActive comparatorHypomineralized 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.

  1. Marginal Integrity

    the crowns is evaluated radiographically using a bite wing radio graph for marginal extension integrity.

    Measured: 9 months follow up

  2. 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

  3. Recurrent caries

    the tooth is evaluated radiographically using a bite wing radio graph for recurrent caries in the molar.

    Measured: 9 months

  4. 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

  5. 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.

  1. First posted24 Dec 2019
  2. Study start1 Mar 2019
  3. Primary completion1 Jan 2021
  4. Study completion1 Apr 2021

Resources

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)
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

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.

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