Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients

April 11, 2025 updated by: Nehal Abdelrahim Amin Elsherif, Cairo University

Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients Rehabilitated With Laser CAD CAM & Conventionally Constructed Obturators

randomized controlled trial in maxillectomy patients with two types of obturators with different manufacturing techniques

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

randomized controlled trial measuring patient satisfaction and abutment teeth health in maxillectomy patients rehabilitated with laser polished CAD CAM obturators versus conventionally constructed obturators

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Patients with hemi maxillectomy
  • Sufficient number of natural teeth not less than 5 teeth
  • Age between 30 and 60 years
  • Intact soft palate

Exclusion Criteria

  • Cognitive impairment
  • Heavy smokers
  • Patients exposed to radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAD CA laser polished obturator
the intervention obturator is to be made digitally with CAD CAM technology then laser polished
Device: obturator
conventionally constructed and polished obturator
Other Names:
  • conventionally constructed obturator
Active Comparator: conventionally constructed obturator
the control group will receive conventionally constructed obturator
Device: obturator
conventionally constructed and polished obturator
Other Names:
  • conventionally constructed obturator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: 3 months
will be assessed by 5-point Likert scale capturing various degrees of opinion from strongly disagree, disagree, neutral agree, to strongly agree. data will be collected and sent to statistician for the analysis required in mean difference and standard deviation.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 11, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1224 (Lineberger Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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