AzTrials
AzTrials

Missing TeethNCT04873635

Expectation and Satisfaction of Implant Rehab After Jaw Surgery

An observational study of Missing Teeth, run by The University of Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Missing Teeth
What is being tested?
Implant support prostheses
How many people
31 participants
Where
No sites listed yet
Study dates
Aug 2003to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Conditions
Missing Teeth
Being tested
Implant support prostheses
Keywords
dental implants, oral surgical procedures, dental prosthesis, implant-supported, patient reported outcome measures, patient satisfaction, quality of life
Medical subject headings
Anodontia, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implant support prosthesesOther

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

Study groups in NCT04873635
Study groupRoleWhat they receive
Patients who had excised pathological jaw lesions and will receive implant rehabilitationNot described
Receives: Other: Implant support prostheses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Before receive implant-supported prosthesis (baseline)

  2. 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

    Measured: Before (baseline) and 3 months post-insertion of implant-supported prosthesis

  3. 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

    Measured: 3 months post-insertion of implant-supported prosthesis

  4. 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

    Measured: 3 months post-insertion of implant-supported prosthesis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study startAug 2003
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04873635
Sponsor's protocol ID
Ref.1/8/12d
Status last verified
May 2021
First submitted
29 Apr 2021
Last updated
10 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be share upon request

Publications

  • Allen PF, O'Sullivan M, Locker D. Determining the minimally important difference for the Oral Health Impact Profile-20. Eur J Oral Sci. 2009 Apr;117(2):129-34. doi: 10.1111/j.1600-0722.2009.00610.x.

    PubMed 19320721

  • Baracat LF, Teixeira AM, dos Santos MB, da Cunha Vde P, Marchini L. Patients' expectations before and evaluation after dental implant therapy. Clin Implant Dent Relat Res. 2011 Jun;13(2):141-5. doi: 10.1111/j.1708-8208.2009.00191.x.

    PubMed 19681923

  • Gurlek A, Miller MJ, Jacob RF, Lively JA, Schusterman MA. Functional results of dental restoration with osseointegrated implants after mandible reconstruction. Plast Reconstr Surg. 1998 Mar;101(3):650-5; discussion 656-9. doi: 10.1097/00006534-199803000-00011.

    PubMed 9500381

  • Heydecke G, Thomason JM, Awad MA, Lund JP, Feine JS. Do mandibular implant overdentures and conventional complete dentures meet the expectations of edentulous patients? Quintessence Int. 2008 Nov;39(10):803-9.

    PubMed 19093056

  • Hundepool AC, Dumans AG, Hofer SO, Fokkens NJ, Rayat SS, van der Meij EH, Schepman KP. Rehabilitation after mandibular reconstruction with fibula free-flap: clinical outcome and quality of life assessment. Int J Oral Maxillofac Surg. 2008 Nov;37(11):1009-13. doi: 10.1016/j.ijom.2008.05.021. Epub 2008 Jul 26.

    PubMed 18657394

  • Iizuka T, Hafliger J, Seto I, Rahal A, Mericske-Stern R, Smolka K. Oral rehabilitation after mandibular reconstruction using an osteocutaneous fibula free flap with endosseous implants. Factors affecting the functional outcome in patients with oral cancer. Clin Oral Implants Res. 2005 Feb;16(1):69-79. doi: 10.1111/j.1600-0501.2004.01076.x.

    PubMed 15642033

  • Jacobsen HC, Wahnschaff F, Trenkle T, Sieg P, Hakim SG. Oral rehabilitation with dental implants and quality of life following mandibular reconstruction with free fibular flap. Clin Oral Investig. 2016 Jan;20(1):187-92. doi: 10.1007/s00784-015-1487-3. Epub 2015 May 12.

    PubMed 25963720

  • Janzen JA, Silvius J, Jacobs S, Slaughter S, Dalziel W, Drummond N. What is a health expectation? Developing a pragmatic conceptual model from psychological theory. Health Expect. 2006 Mar;9(1):37-48. doi: 10.1111/j.1369-7625.2006.00363.x.

    PubMed 16436160

  • Kim HY. Statistical notes for clinical researchers: effect size. Restor Dent Endod. 2015 Nov;40(4):328-31. doi: 10.5395/rde.2015.40.4.328. Epub 2015 Oct 2. No abstract available.

    PubMed 26587420

  • King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res. 2011 Apr;11(2):171-84. doi: 10.1586/erp.11.9.

    PubMed 21476819

  • Kramer FJ, Dempf R, Bremer B. Efficacy of dental implants placed into fibula-free flaps for orofacial reconstruction. Clin Oral Implants Res. 2005 Feb;16(1):80-8. doi: 10.1111/j.1600-0501.2004.01040.x.

    PubMed 15642034

  • Leung AC, Cheung LK. Dental implants in reconstructed jaws: patients' evaluation of functional and quality-of-life outcomes. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):127-34.

    PubMed 12608678

  • Li X, Zhu K, Liu F, Li H. Assessment of quality of life in giant ameloblastoma adolescent patients who have had mandible defects reconstructed with a free fibula flap. World J Surg Oncol. 2014 Jul 8;12:201. doi: 10.1186/1477-7819-12-201.

    PubMed 25004805

  • Locker D. Measuring oral health: a conceptual framework. Community Dent Health. 1988 Mar;5(1):3-18. No abstract available.

    PubMed 3285972

  • Locker D. Issues in measuring change in self-perceived oral health status. Community Dent Oral Epidemiol. 1998 Feb;26(1):41-7. doi: 10.1111/j.1600-0528.1998.tb01923.x.

    PubMed 9511841

Questions about this trial

What is this clinical trial studying?

An observational study of Missing Teeth, run by The University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient expectation of implant-supported prosthesis (time frame: Before receive implant-supported prosthesis (baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04873635, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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