Ignite Creation Date:
2024-05-06 @ 4:16 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922372
Status:
UNKNOWN
Last Update Posted:
2021-06-16
First Post:
2021-06-05
Brief Title:
Surface Texture and Clinical Performance of Milled BioHPP Polyetheretherketone PEEK Single Posterior Crowns Veneered With Two Different Techniques
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Surface Texture and Clinical Performance of Milled BioHPP Polyetheretherketone PEEK Single Posterior Crowns Veneered With Two Different Techniques Randomized Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-06
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research question
For patients requiring posterior single crowns does the use of Milled BioHPP PEEK copings veneered with CADCAM composite resin offer better surface texture and clinical performance when compared Milled BioHPP PEEK copings veneered with manual layering
Statement of the problem Nowadays metal free restorations are widely used PEEK is one among these restorations that has many applications in dental field Owing to PEEKs excellent mechanical properties it is gaining popularity in prosthodontics The opaque nature of PEEK allows its use as a framework material in fixed prosthodontics and composite resin material is used as a veneering material to achieve aesthetics
The compatible composite veneering material can be manufactured by both manual and CADCAM techniques Yet there is no enough research regarding the influence of the veneering technique on the surface texture and clinical performance of these restorations
Rationale PEEK combination of mechanical properties and high biocompatibility make it a very promising material PEEK based crowns are veneered by composite resin material Among the methods of fabrication of veneering composite is the manual layering and CADCAM techniques The surface flaws and internal defects determine the strength of the material and affects its performance Accordingly the evaluation of the veneering technique is mandatory
The rationale for carrying out this study lies in providing an alternative solution to the manual veneering technique which will in-turn provide better surface properties and clinical performance of the restoration and accordingly increase its longevity
Aim of the study
- The aim of this study is to evaluate the surface texture and clinical performance of milled BioHPP PEEK veneered with CADCAM composite resin and compare them to milled BioHPP PEEK veneered manually
Null hypothesis
There is no difference in the surface texture and clinical performance between milled BioHPP PEEK veneered with CADCAM composite resin and milled BioHPP PEEK veneered manually
Primary objective
Primary outcome surface texture of the two groups will be assessed using the modified USPHS
Secondary outcome fracture of the two groups will be assessed using the modified Ryge criteria
For patients requiring posterior single crowns does the use of Milled BioHPP PEEK copings veneered with CADCAM composite resin offer better surface texture and clinical performance when compared Milled BioHPP PEEK copings veneered with manual layering
Statement of the problem Nowadays metal free restorations are widely used PEEK is one among these restorations that has many applications in dental field Owing to PEEKs excellent mechanical properties it is gaining popularity in prosthodontics The opaque nature of PEEK allows its use as a framework material in fixed prosthodontics and composite resin material is used as a veneering material to achieve aesthetics
The compatible composite veneering material can be manufactured by both manual and CADCAM techniques Yet there is no enough research regarding the influence of the veneering technique on the surface texture and clinical performance of these restorations
Rationale PEEK combination of mechanical properties and high biocompatibility make it a very promising material PEEK based crowns are veneered by composite resin material Among the methods of fabrication of veneering composite is the manual layering and CADCAM techniques The surface flaws and internal defects determine the strength of the material and affects its performance Accordingly the evaluation of the veneering technique is mandatory
The rationale for carrying out this study lies in providing an alternative solution to the manual veneering technique which will in-turn provide better surface properties and clinical performance of the restoration and accordingly increase its longevity
Aim of the study
- The aim of this study is to evaluate the surface texture and clinical performance of milled BioHPP PEEK veneered with CADCAM composite resin and compare them to milled BioHPP PEEK veneered manually
Null hypothesis
There is no difference in the surface texture and clinical performance between milled BioHPP PEEK veneered with CADCAM composite resin and milled BioHPP PEEK veneered manually
Primary objective
Primary outcome surface texture of the two groups will be assessed using the modified USPHS
Secondary outcome fracture of the two groups will be assessed using the modified Ryge criteria
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 CADCAM technology then veneered with two veneering techniques the CAD CAM and the manual technique using the visiolign 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 visits8 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None