Patient Satisfaction , Marginal Adaptation And Biocompatibility of Milled Biohpp Polyetheretherketone (PEEK) Single Anterior Crowns Veneered With Two Different Techniques.
Condition: Patient Satisfaction; Gingival Bleeding
MeSH terms: Gingival Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Research question For patients in a need for anterior crown, does the use of Milled BioHPP
      PEEK copings veneered with CAD/CAM composite resin offer better patient satisfaction,
      marginal adaptation and biocompatibility when compared Milled BioHPP PEEK copings veneered
      with manual layering? Statement of the problem PEEK exhibits a unique modulus of elasticity
      close to human bone/dentine so it acts as a shock absorber with stress reducing effect.
      Moreover from a biologic point of view, PEEK is highly compatible with surrounding tissues
      and it has very promising surface properties . The use of peek in anterior area is limited
      due to its opaque nature and grayish color, this drawback has been overcome by the use of
      composite layering material . PEEK restorations can be veneered with manual or CAD/CAM
      techniques. Information is lacking regarding the influence of the veneering technique on the
      patient satisfaction , precision of fit and biocompatibility of these restorations which will
      in turn influence their performance in patient's satisfaction.

      Rationale To achieve high esthetics when using PEEK it must be veneered by esthetic material
      3 . It is available to be used manually or to be milled by CAD/CAM. The manual veneering of
      the PEEK coping with composite might affect the marginal integrity and the surrounding
      gingival tissues leading to decrease in the patient satisfaction, while the CAD/CAM veneering
      technique is proposed to have better patient satisfaction , marginal adaptation and an
      excellent biocompatible effect on the surrounding tissue. The importance of this trial lies
      in providing an alternative solution to the manual veneering technique, which will, in-turn,
      provide better restoration longevity results

      Aim of the study:

      The aim of this study is to evaluate the patient satisfaction ,marginal adaptation and
      biocompatibility of milled BioHPP PEEK copings veneered with CAD/CAM composite resin and
      compare them to milled BioHPP PEEK copings veneered with manual layering.

      Null hypothesis:

      There is no difference in the patient satisfaction, marginal adaptation and biocompatibility
      between milled BioHPP PEEK copings veneered with CAD/CAM composite resin and milled BioHPP
      PEEK copings veneered with manual layering.

      Primary objective: - The Primary outcome: : patient satisfaction of the two groups will be
      assessed by rating score 0 unaccepted , 1 good , 2 excellent - Secondary outcome: Marginal
      adaptation of the two groups will be assessed using the modified Ryge criteria. - Tertiary
      outcome: Biocompatibility (Bleeding). Signs of inflammation and bleeding of the two groups
      will be recorded after clinical examination and probing using periodontal probe Trial design:
      - Randomized clinical trial

      Eligibility criteria:

      Inclusion criteria:

      All subjects are required to be: 1-From 18-50 years old, be able to read and sign the
      informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with
      good restorations 3- Psychologically and physically able to withstand conventional dental
      procedures 4- Patients in a need for anterior crown. 5- Able to return for follow-up
      examinations and evaluation Exclusion criteria

      1. Patient less than 18 or more than 50 years 2. Patient with active resistant periodontal
      diseases 3. Patients with poor oral hygiene and uncooperative patients 4. Pregnant women 5.
      Patients in the growth stage with partially erupted teeth 6. Psychiatric problems or
      unrealistic expectations
    

Detailed description: 
      Intervention: Examination and diagnosis: - Selection and examination of the patients
      according to inclusion and exclusion criteria. Diagnosis of the patients' chief complaint and
      teeth that will be involved in this study will be done then performing proper scaling and
      polishing procedure, Primary impression will be taken to produce study cast. The patients
      will be asked to maintain good oral hygiene measures by using tooth brush twice daily. -
      Taking a pre-operative professional photo, Tooth preparation procedure: Recording the sulcus
      depth and gingival condition prior to preparation, Conservative tooth preparation will be
      prepared after local anesthesia has been given as required., Full coverage preparation will
      be carried out , After tooth preparation, adequate 2ry Impression using non aqueous
      elastomeric impression materials and bite registration will be taken., Fabrication of the
      temporary restoration using composite resin temporary material and cemented using non Eugenol
      Zinc Oxide temporary cement, Fabrication and cementation of restoration: Bio-HPP will be
      supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered
      with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign
      system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin
      cement according to manufacturer instruction, Criteria for discontinuing: Restoration will be
      removed when there are any signs of leakage, fracture or severe post-operative pain due to
      pulpal response and replaced by a temporary restoration cemented with Ca (OH) cement in order
      to alleviate pain, Strategies to improve adherence to intervention protocol: - ''In the first
      visit, a Face to Face adherence session will be held in which the patient should be informed
      about the study steps and how to maintain oral hygiene measures. Further sessions will occur
      at the follow-up visits.8 Participant patients will be asked about any problems they are
      having. Patients will be recalled every three months for one year for follow up visits.
      Permitted or prohibited interventions: Oral hygiene measures are permitted for enhanced
      results while using hard tooth brushes or abrasive containing tooth paste after intervention
      are prohibited.
    

Intervention name(s): peek
Intervention type(s): Combination Product
Intervention description(s): After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1. Recording the sulcus depth and gingival condition prior to preparation. 2. Conservative tooth preparation will be prepared after local anesthesia has been given as required. 3. Full coverage preparation will be carried out . 3. After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment