A Comparison of Two Different Management Techniques for Extensive Molar Defects in Patients Suffering From MIH
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

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 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.

        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.
    

Intervention name(s): CAD-CAM milled PMMA crown; Cast metal coping using nickel chromium alloy
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Intervention MeSH terms: Chromium; Nickel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Molar Incisor Hypomineralization; MIH; Hypomineralized; First permanent molar; Molar defects; PMMA; cast adhesive coping