PEEK Versus Metallic Attachment-retained Obturators

Cairo University (CU)

Status: Completed

Conditions: Maxillary Neoplasms

Treatments: Other: conventional obturator; Other: metalic attachment retained obturator; Other: PEEK attachment retained obturator

Study type: Interventional

Funder types: Other

Identifiers

NCT04778254

38/10/2018

Details and patient eligibility

About

Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases.

Full description

Eighteen participants were randomly divided into three parallel groups (n=6). Participants of PEEK group received attachment-retained obturators with milled PEEK framework, metal group received an attachment-retained obturator with metallic framework and conventional group received conventional clasp-retained obturators with metallic framework (Control group). Evaluation included radiographic evaluation and patients' satisfaction where two scales were followed in this study, including "The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one way ANOVA test.

Enrollment: 18 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient underwent surgical removal of half of maxilla
• participants with a sufficient number of natural teeth(class I and \or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,

Exclusion criteria

• participants are exposed to radiotherapy or chemotherapy during last year.
• participant with congenital defect

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

18 participants in 3 patient groups

conventional obturator

Active Comparator group

Description:

conventional group received conventional clasp-retained obturators with metallic framework (Control group).

Treatment:

Other: conventional obturator

metallic attachment retained obturator

Experimental group

Description:

metal group received an attachment-retained obturator with metallic framework

Treatment:

Other: metalic attachment retained obturator

PEEk attachment retained obturator

Experimental group

Description:

PEEK group received attachment-retained obturators with milled PEEK framework,

Treatment:

Other: PEEK attachment retained obturator