Missing Teeth Clinical Trial
Official title:
Patient's Expectation and Satisfaction of Implant-supported Prostheses After Excision of Pathological Jaw Lesions: A Prospective Follow-up Study
NCT number | NCT04873635 |
Other study ID # | Ref.1/8/12d |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2003 |
Est. completion date | December 2019 |
Verified date | May 2021 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objective: The aim of this prospective study was to investigate the patient-reported outcome measures (PROMs) of implant-supported prostheses (ISP) among patients who had excised pathological jaw lesions. Material and Methods: Patients who met the inclusion/exclusion criteria in a dental teaching hospital were recruited. Data pertaining to sociodemographic factors, conditions requiring surgery, surgical procedures and related complications, and types of ISP were collected. Patients' expectation and satisfaction to the ISP including oral health, self-perceived appearance, speech, chewing ability, oral comfort and ease of cleaning were assessed using the visual analogue scale (VAS, 0-100) and global transitional scale/judgement (Likert scale). Data were analysed using t-test and chi-square tests at the significance level α=0.05.
Status | Completed |
Enrollment | 31 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects who have received surgical removal of pathological jaw lesions in Queen Mary Hospital - Subjects who plan to receive implant-supported prostheses in Prince Philip Dental Hospital Exclusion Criteria: - Subjects with debilitating illnesses or complicating medical conditions - Subjects who under age of 18 or unable to give consent - Subjects with uncontrolled caries and periodontal disease |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient expectation of implant-supported prosthesis | Visual analogue scale 0-100 which 0 is "No expectation" and 100 is "High expectation"
Assess general satisfaction, appearance, speech, chewing hard/soft/fibrous foods, comfort, cleaning, occlusion, stability and in comparison to natural teeth |
Before receive implant-supported prosthesis (baseline) | |
Primary | Patient satisfaction of implant-supported prosthesis in 3-point Likert transition scale | Assess changes in oral condition, appearance, speech, chewing hard/soft/fibrous foods, oral comfort and cleaning following jaw surgery and oral rehabilitation
Global transition judgements: Better, No difference, Worse |
Before (baseline) and 3 months post-insertion of implant-supported prosthesis | |
Primary | Patient satisfaction of implant-supported prosthesis in 0-100 visual analogue scale | Visual analogue scale 0-100 which 0 is totally unsatisfied and 100 is totally satisfied
Assess oral health, appearance, speech, chewing hard/soft/fibrous foods, comfort, cleaning, occlusion, and the ability to chew and bite |
3 months post-insertion of implant-supported prosthesis | |
Primary | Patient satisfaction of implant-supported prosthesis in 5-point Likert scale | Assess
1. Feeling of health of own teeth, lips, jaw and mouth Global transition scales: Very good, Good, Fair, Poor, Very Poor 2: Extent of oral health affecting overall life Global transition scales: Very much, A lot, Some, Very little, Not at all |
3 months post-insertion of implant-supported prosthesis |
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