Evaluation of Clinical Performance of 3D Printed Polyether Ether Ketone (PEEK) Inlays

Evaluation of Clinical Performance of 3D Printed Polyether Ether Ketone (PEEK) Inlays Compared With Milled Indirect PEEK Inlays Versus Indirect Resin Composite Inlays Over One Year Period of Time (A Randomized Clinical Trial)

In patients using Inlay restorations will the use of 3D printed PEEK material and technique have superior clinical performance to milled PEEK one or to milled composite resin inlays, evaluation of restorations will be done at baseline, six months and 12 months using the modified US Public Health Service (USPHS) evaluation system

Study Overview

• Status: Unknown
• Conditions: Occlusal Caries
• Intervention / Treatment: Other: Poly ether ether ketone (PEEK); Other: CADCAM Poly ether ether ketone (PEEK); Other: indirect resin composite

Detailed Description

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Donia Mamdouh Elshafey Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University All cavity preparations will be performed with fine inlay burs according to inlay cavity principles. The walls facing each other will be prepared 5 to 6 degree divergent with 80 μm diamond burs and were finished with 25 μm diamond burs. All internal angles will be rounded and all edges will terminate in the enamel. The pulpal floor will be prepared at a depth of at least 1.5 mm. The teeth will be discarded if isthmus width was more than 2/3 of the distance between the tubercule tips, or if the walls are thinner than 2 mm before the preparation or thinner than 1.5 mm after the preparation. The caries affected dentin tissue at the cavity floor will be left. The teeth will be discarded from study if the pulp is exposed. To eliminate irregular areas in the cavities, a liner will be applied as a blockout material. Then the operator will adhere strictly to the manufacturer's instructions in the imaging, computer design and machining of the restorations either 3D printing or milling procedure.

The prepared teeth for the indirect restorations will be scanned with an optical 3D camera (CEREC Omnicam, Dentsply Sirona, Bensheim, Germany), inlays will be designed by a CAD software (CEREC SW 4.6.1, Dentsply Sirona), and files will be created in STL format (inLab CAD SW 18.1, Dentsply Sirona) then inlays will additively manufactured After the printing process is finished, the inlays will be immediately removed from the building platform and cooled down at room temperature. The inlay will be adapted individually to its cavity, and the occlusal surface will be recontoured. Such post processing also will be performed on the milled inlays. After all inlays are adequately adapted, they will be adhesively inserted into the cavities.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aging greater than or equal 18 years.
• Patients with a high level of oral hygiene.
• Each patient enrolled in the study had moderate to large size carious lesion or defective restoration to be replaced on a maxillary or mandibular permanent molar.
• Patients with good likelihood of recall availability.

Exclusion Criteria:

• Participants with general/systemic illness.
• Pregnant or lactating females.
• Concomitant participation in another research study.
• Inability to comply with study procedures.
• Heavy bruxism habits.
• Last experience with allergic reactions against any components of the used materials.
• Patients receiving orthodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Poly ether ether ketone (PEEK); Poly ether ether keton (PEEK) is acknowledged as a high-performance polymer in engineering & medical applications due to its favorable mechanical and chemical properties.	Other: Poly ether ether ketone (PEEK); PEEK has been used in dentistry so far in certain fields as for, removable and fixed dental prostheses, implants, and implant abutments as well as orthodontic devices, whereas in literature, it is mostly mentioned in relation to prosthetics. PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. Producing dental restorations via Additive manufacturing is still hardly widespread
Other: CADCAM poly ether ether ketone (PEEK); PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks.	Other: CADCAM Poly ether ether ketone (PEEK); Increased demand for long-lasting restoration's properties have led to many improvements in the production techniques of posterior restorations such as CAD/CAM systems. This technique simplifies the production of indirect restorations and make it possible to use advanced materials as PEEK
Active Comparator: indirect resin composite; In CAD/CAM resin composite blocks, properties of flexibility and ease of use similar to that of resin composite are combined with durability and surface finish properties similar to that of ceramics	Other: indirect resin composite; CADCAM resin composite blocks using milling process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal integrity	Visual inspection with explorer and mirror, Distance penetrated by the Explorer at the tooth restoration interface	12 months
marginal discoloration	Visual inspection with a mirror at 18 inches, the degree of mismatch from the normal range of tooth shades and translucency Visual inspection to check the proximity of the shade from the natural tooth	12 months
secondary caries	Visual inspection of discoloration that occurs on the tooth after the filling has been used for a period of time	12 months
post operative sensitivity	Asking the patient if there is any associated pain after adding the restoration	12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Donia M elshafey, master, Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Anesthetics, Inhalation; Ether
• Other Study ID Numbers: 88245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Undecided: It is not yet known if there will be a plan to make IPD available.
• IPD Sharing Time Frame: expecting to have all the data during october 2022
• IPD Sharing Access Criteria: IPD through contacting the main author doniamamdouh@dentistry.cu.edu.eg.com
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No