NCT03146624

Brief Summary

OBJECTIVE to evaluate patients satisfaction of obturator with attachment versus conventional obturator in treatment of unilateral maxillectomy .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2015

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

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 4, 2017

Last Update Submit

May 9, 2017

Conditions

Tumour

Outcome Measures

Primary Outcomes (2)

  • patient satisfaction

    questionnaires"The Obturator Functioning Scale"

    1 month

  • patient satisfaction

    questionnaires " The European Organization for Research and Treatment of Cancer Head and Neck 35"

    1 month

Study Arms (2)

attachment

EXPERIMENTAL

attachment retained obturator

Other: attachment retained obturator

clasp

ACTIVE COMPARATOR

clasp retained obturator

Other: clasp retained obturator

Interventions

attachment retained obturatorOTHER

obturator which retained by attachment

Also known as: obturator with attachment
attachment
clasp retained obturatorOTHER

obturator which retained by clasp

Also known as: obturator with clasp
clasp

Eligibility Criteria

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

You may qualify if:

  • \- patients with sufficient number of natural teeth(class I and \\or class IV Aramany classification),
  • \- intact soft palate, 3- the mouth opening is not less than 25 mm .

You may not qualify if:

  • patients are exposed to radiotherapy or chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Yahia Sharaf

Cairo, 11599, Egypt

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 10, 2017

Study Start

December 1, 2015

Primary Completion

February 21, 2017

Study Completion

March 28, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Locations

EG(1)