One Year Clinical Evaluation of Milled BioHPP (PEEK) Versus Zirconia Veneered Single Crowns (RCT-one-year Evaluation).

NCT03701178 | Unknown

• 1 other identifier: CEBD-CU-2018-09-38
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. Long term success of all ceramic crowns is affected by many factors. Fracture of the all ceramic crowns is the most repeated failure pattern and represents about 67% of total failures associated with this type of restoration through a period of 15 years of clinical performance. 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.

Conditions

Carious Tooth

Outcome Measures

Primary Outcomes (1)

• fracture

  number of fracture

  1 year

Secondary Outcomes (1)

• marginal interity

  1 year

Other Outcomes (1)

• patient satisfaction

  1 year

Study Arms (2)

zirconia veneered crowns

ACTIVE COMPARATOR

we will use zirconia veneered single crowns as a control to evaluate the marginal integrity and fracture and patient satisfaction

Other: BioHPP PEEK

milled BioHpp PEEK

EXPERIMENTAL

we will use milled BioHPP PEEK single crowns as a intervention to evaluate the marginal integrity and fracture and patient satisfaction

Other: BioHPP PEEK

Interventions

BioHPP PEEK OTHER

milled BioHPP PEEK in a new material can be used as a dental restoration

milled BioHpp PEEK; zirconia veneered crowns

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• From 18-50 years old, be able to read and sign the informed consent document.
• Have no active periodontal or pulpal diseases, have teeth with good restorations
• Psychologically and physically able to withstand conventional dental procedures
• Patients with teeth problems indicated for single posterior crowns: (Badly decayed teeth / Teeth restored with large filling restorations / Endodontically treated teeth / Malformed teeth / Malposed teeth (Tilted, over-erupted, rotated, etc.) / Spacing between posterior teeth)
• Able to return for follow-up examinations and evaluation.

You may not qualify if:

• Patient less than 18 or more than 50 years
• Patient with active resistant periodontal diseases
• Patients with poor oral hygiene and uncooperative patients
• Pregnant women
• Patients in the growth stage with partially erupted teeth
• Psychiatric problems or unrealistic expectations
• Lack of opposing dentition in the area of interest

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• abdelrahman M el sokkary, mastrer

  researcher

  STUDY CHAIR

Central Study Contacts

abdelrahman mustafa, M.D.s

CONTACT

01024884480; dr_lamina_propria@windowslive.com

Lamia Sayed, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer , fixed prosthodontic department, faculty of dentistry ERU

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 9, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 11, 2018

Record last verified: 2018-10