Expectation and Satisfaction of Implant Rehab After Jaw Surgery

May 5, 2021 updated by: Dr. Walter Y.H. Lam, The University of Hong Kong

Patient's Expectation and Satisfaction of Implant-supported Prostheses After Excision of Pathological Jaw Lesions: A Prospective Follow-up Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before receive implant-supported prosthesis (baseline)
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
Before (baseline) and 3 months post-insertion of implant-supported prosthesis
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
3 months post-insertion of implant-supported prosthesis
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
3 months post-insertion of implant-supported prosthesis

Collaborators and Investigators

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

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Walter Lam, Faculty of Dentistry, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2003

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ref.1/8/12d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be share upon request

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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