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Completed

NCT Number: NCT04873635

Expectation and Satisfaction of Implant Rehab After Jaw Surgery

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implant support prostheses

Other

Implant support prostheses was provided to restore the missing teeth and tissues removed due to pathological jaw lesions

Primary outcomes

  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

    • 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2019
Study completion
2019
First posted
May 5, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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