NCT06934551

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress71%
Dec 2024Dec 2026

Study Start

First participant enrolled

December 10, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

April 3, 2025

Last Update Submit

April 11, 2025

Conditions

Maxillary Diseases

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    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

Study Arms (2)

CAD CA laser polished obturator

EXPERIMENTAL

the intervention obturator is to be made digitally with CAD CAM technology then laser polished

Device: obturator

conventionally constructed obturator

ACTIVE COMPARATOR

the control group will receive conventionally constructed obturator

Device: obturator

Interventions

obturatorDEVICE

conventionally constructed and polished obturator

Also known as: conventionally constructed obturator
CAD CA laser polished obturatorconventionally constructed obturator

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Cognitive impairment
  • Heavy smokers
  • Patients exposed to radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Maxillary Diseases

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 18, 2025

Study Start

December 10, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)