NCT04778254

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

February 22, 2021

Last Update Submit

February 26, 2021

Conditions

Maxillary Neoplasms

Outcome Measures

Primary Outcomes (2)

  • patient satisfaction 1(change" is being assessed)

    The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"

    1 week to 6 months

  • patient satisfaction 2 (change" is being assessed)

    The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"

    1 week to 6 months

Secondary Outcomes (1)

  • Radiographic evaluation (change" is being assessed)

    base line,6 months, 9 months,12 months

Study Arms (3)

conventional obturator

ACTIVE COMPARATOR

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

Other: conventional obturator

metallic attachment retained obturator

EXPERIMENTAL

metal group received an attachment-retained obturator with metallic framework

Other: metalic attachment retained obturator

PEEk attachment retained obturator

EXPERIMENTAL

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

Other: PEEK attachment retained obturator

Interventions

PEEK attachment retained obturatorOTHER

attachment retained obturator for management of hemi maxillectomy

Also known as: milled PEEK obturator
PEEk attachment retained obturator
metalic attachment retained obturatorOTHER

attachment retained obturator for management of hemi maxillectomy

Also known as: attachment retained obturator
metallic attachment retained obturator
conventional obturatorOTHER

clasp retained obturator for management of hemi maxillectomy

Also known as: clasp retained obturator
conventional obturator

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Sharaf

Cairo, 11625, Egypt

Location

MeSH Terms

Conditions

Maxillary Neoplasms

Condition Hierarchy (Ancestors)

Jaw NeoplasmsSkull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesJaw DiseasesMaxillary DiseasesStomatognathic Diseases

Study Officials

  • Mohamed Sharaf, lecturer

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 3, 2021

Study Start

February 1, 2018

Primary Completion

July 1, 2019

Study Completion

August 30, 2019

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

EG(1)