Effect of Different Types Crowns on Bio Compatibility and Biological Tissue Response
Condition: Personal Satisfaction
Study type: Interventional

Summary: 
      The aim of this study compare soft tissue reaction (bleeding, gingival color and texture),
      bacteria type and count in the gingival sulcus around the restoration margin and sulcus depth
      of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless its
      popularity in the dental field.
    

Detailed description: 
      Roles and responsibilities:

        1. Esra'a Mohamed Ali Mraweh (E.M):Operator, data enterer and corresponding
           author;Assistant lecturer, Fixed Prosthodontics Department, Modern Technology and
           Information University (MTI University), Egypt.

        2. Dr. Hesham Alansary ( H.A):Main supervisor, data monitoring, auditing Professor, Fixed
           prosthodontics department, Faculty of Oral and Dental Medicine, Cairo University, Egypt.

        3. Nora Helmy (N.H):Outcome assessors and data collection;Assistant Lecturers, Fixed
           Prosthodontics department, Faculty of Oral and Dental Medicine, Modern Technology and
           Information University (MTI university), Egypt.

        4. Noha Moustafa (N.M):Base line data collection, recruitment, sequence generation,
           allocation concealment, patient retention and taking participants' consents;Resident,
           Fixed Prosthodontics Department, Faculty of Oral and Dental Medicine, Modern Technology
           and Information University (MTI University), Egypt.

        5. Eman Desouky (E.D.):Sample size calculation; Statistician,Faculty of Oral and Dental
           Medicine, Cairo University, Egypt.

        6. Evidence Based Dentistry Committee (CEBD): Help in reporting study protocol following
           SPIRIT guidelines;Faculty of Oral and Dental Medicine, Cairo University, Egypt.

        7. Research Ethics Committee (CREC): Protocol reviewer of the clinical trial in order to
           protect the right, safety, dignity and well-being of the participants.

      Faculty of Oral and Dental Medicine, Cairo University, Egypt.

      8. Research Plan Committee (CRPC): For ensuring that this clinical trial following the
      department research plan; Fixed Prosthodontic Department, Faculty of Oral and Dental
      Medicine, Cairo University, Egypt.

        1. Intervention:E.M. will record the crevice depth and bacterial count prior to
           preparation. E.M. will perform full coverage conservative tooth preparation following
           principles of all ceramic crown preparation with shoulder sub-gingival finish line of
           thickness 1mm using tapered stone with flat end attached to high speed headpiece with
           air and water coolant after local anesthesia has been given as required.After tooth
           preparation, E.M will take an adequate 2ry Impression using non aqueous Elastomeric
           impression materials Impregum™F( medium consistency,3M ESPE) and bite registration, Pink
           Soft wax(Star dental supply)will be taken. E.M will fabricate the temporary restoration
           using composite resin temporary material Protemp™4 Temporisation Material (3M ESPE) and
           cemented using non Eugenol Zinc Oxide temporary cement TempBond™ Temporization( Kerr
           Dental).

           E.M will deliver pressed Bio-compatible High performance polymer (Bio-HPP) frame work
           veneered with visio.lign system (Bredent) cemented by a self adhesive resin cement

        2. Comparator: E.M. will record the crevice depth and bacterial count prior to preparation.
           E.M. will perform full coverage conservative tooth preparation following principles of
           all ceramic crown preparation with shoulder sub-gingival finish line of thickness 1mm
           using tapered stone with flat end attached to high speed headpiece with air and water
           coolant after local anesthesia has been given as required.After tooth preparation, E.M
           will take an adequate 2ry Impression using non aqueous Elastomeric impression materials
           Impregum™F( medium consistency,3M ESPE) and bite registration, Pink Soft wax(Star dental
           supply)will be taken. E.M will fabricate the temporary restoration using composite resin
           temporary material Protemp™4 Temporisation Material (3M ESPE) and cemented using non
           Eugenol Zinc Oxide temporary cement TempBond™ Temporization( Kerr Dental).

           E.M. will deliver Pres-sable E-max (IPS e.max®) framework will be veneered with e-max
           veneering system (Ivoclar Vivadent) .The finished crown will be cemented by
           Self-Adhesive resin Cemen taccording to manufacturer instructions.

        3. Outcome:(i)Patient satisfaction (bio-compatibility) measure patient satisfaction using
           data in questionnaire (presence or absence of bleeding.) The main and standard deviation
           for the questionnaire of patient at the time crown cementation, 3, 6,9 and 12 months
           will be recorded.

      (ii) Clinical biological outcome:

        -  measure the Crevice depth using periodontal probe and record the depth in millimeters
           collected a swap from the teeth and Bacterial count will be measured using culture
           number of cells per millimeter

        -  The main and standard deviation for all collected data ,at the time of crown
           cementation, 3, 6,9 and 12 months will be recorded.
    

Intervention name(s): All ceramic crown; Hybrid crown
Intervention type(s): Other; Other
Intervention description(s): Pressed E-Max coping veneered with E-max veneering system; pressed Bio HPP veneered with Visio-Lign Veneering system
Other intervention name(s): Prosthetic crown; Prosthetic crown
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment