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Expectation and Satisfaction of Implant Rehab After Jaw Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04873635
Recruitment Status : Completed
First Posted : May 5, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Walter Y.H. Lam, The University of Hong Kong

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Missing Teeth Other: Implant support prostheses

Study Design
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Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Patient's Expectation and Satisfaction of Implant-supported Prostheses After Excision of Pathological Jaw Lesions: A Prospective Follow-up Study
Actual Study Start Date : August 2003
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients who had excised pathological jaw lesions and will receive implant rehabilitation Other: Implant support prostheses
Implant support prostheses was provided to restore the missing teeth and tissues removed due to pathological jaw lesions


Outcome Measures
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Primary Outcome Measures :
  1. Patient expectation of implant-supported prosthesis [ Time Frame: Before receive implant-supported prosthesis (baseline) ]

    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


  2. Patient satisfaction of implant-supported prosthesis in 3-point Likert transition scale [ Time Frame: Before (baseline) and 3 months post-insertion of implant-supported prosthesis ]

    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


  3. Patient satisfaction of implant-supported prosthesis in 0-100 visual analogue scale [ Time Frame: 3 months post-insertion of implant-supported prosthesis ]

    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


  4. Patient satisfaction of implant-supported prosthesis in 5-point Likert scale [ Time Frame: 3 months post-insertion of implant-supported prosthesis ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had received surgical removal of pathological jaw lesions in a university teaching hospital, Queen Mary Hospital, and planned to receive implant-supported reconstruction in a dental teaching hospital, Prince Philip Dental Hospital, Hong Kong, China were recruited
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04873635


Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Walter Lam Faculty of Dentistry, The University of Hong kong
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Dr. Walter Y.H. Lam, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04873635    
Other Study ID Numbers: Ref.1/8/12d
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be share upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Walter Y.H. Lam, The University of Hong Kong:
dental implants
oral surgical procedures
dental prosthesis, implant-supported
 patient reported outcome measures
patient satisfaction
quality of life
Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
 Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities