Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns

Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth Clinical Trial

Official title:

Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04052789
• Other study ID #: CEBD-CU-2019-08-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: Nahla Adly, M.D.S
• Phone: 01010604355
• Email: Dr.nahla.81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. The success of dental restorations is determined by four main factors: biocompatibility, aesthetic value, resistance to fracture and marginal adaptation. . An inadequate marginal fit may compromise the longevity of the restoration since cement film exposure to the oral environment can lead to its dissolution . .

Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce.

Aim of the study:

• The aim of this study is to evaluate the internal fit of milled BioHPP PEEK-based versus zirconia-based single crowns.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• From 18-50 years old, be able to read and sign the informed consent document.

• Patient Have no active periodontal or pulpal diseases, have teeth with good restorations

• Patient Psychologically and physically able to withstand conventional dental procedures

• Patients with teeth problems indicated for single posterior crowns:

Exclusion Criteria:

• Patient less than 18 or more than 50 years

• Patient with active resistant periodontal diseases

• Patients with poor oral hygiene and uncooperative patients

• Patients in the growth stage with partially erupted teeth

• Patient with Psychiatric problems or unrealistic expectations

• Patient with Lack of opposing dentition in the area of interest

Related Conditions & MeSH terms

• Badly Decayed Teeth andTeeth Restored With Large Filling Restorations and Endodontically Treated Teeth and Malformed Teeth and Malposed Teeth
• Dental Caries
• Tooth Abnormalities
• Tooth, Nonvital

Intervention

Other:
• BioHPP PEEK copings veneered with composite resin
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 . Participant patients will be asked about any problems they are having. Patients will be recalled every two months for one year for follow up visits.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction	Measured by VAS(questionnaire)Numerical (discrete) ("0" unsatisfied - "10" satisfied)	one year
Primary	Internal fit of the crown by measuring the thickness of the replica by steriomicroscope	measured by replica technique and steriomicroscope	one year
Secondary	secondary caries if present at the margin of the crown by using probe	Measured by modified Ryge criteria Alpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration.; Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but notAlpha (A)The restoration is a continuation of existing anatomic form adjacent to the restoration.; Bravo (B)There is visual evidence of dark keep discoloration adjacent to the restoration (but not directly associated with cavosurface margins).; directly associated with cavosurface margins).	one year