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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2021
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

References & Publications (31)

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. — View Citation

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. — View Citation

Chang YM, Wallace CG, Hsu YM, Shen YF, Tsai CY, Wei FC. Outcome of osseointegrated dental implants in double-barrel and vertically distracted fibula osteoseptocutaneous free flaps for segmental mandibular defect reconstruction. Plast Reconstr Surg. 2014 N — View Citation

Gürlek 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. — View Citation

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. — View Citation

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. — View Citation

Iizuka T, Häfliger 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Locker D. Issues in measuring change in self-perceived oral health status. Community Dent Oral Epidemiol. 1998 Feb;26(1):41-7. Review. — View Citation

Locker D. Measuring oral health: a conceptual framework. Community Dent Health. 1988 Mar;5(1):3-18. Review. — View Citation

Nordenram G, Davidson T, Gynther G, Helgesson G, Hultin M, Jemt T, Lekholm U, Nilner K, Norlund A, Rohlin M, Sunnegårdh-Grönberg K, Tranæus S. Qualitative studies of patients' perceptions of loss of teeth, the edentulous state and prosthetic rehabilitatio — View Citation

Ooi A, Feng J, Tan HK, Ong YS. Primary treatment of mandibular ameloblastoma with segmental resection and free fibula reconstruction: achieving satisfactory outcomes with low implant-prosthetic rehabilitation uptake. J Plast Reconstr Aesthet Surg. 2014 Ap — View Citation

Pappalardo M, Tsao CK, Tsang ML, Zheng J, Chang YM, Tsai CY. Long-term outcome of patients with or without osseointegrated implants after resection of mandibular ameloblastoma and reconstruction with vascularized bone graft: Functional assessment and qual — View Citation

Parbo N, Murra NT, Andersen K, Buhl J, Kiil B, Nørholt SE. Outcome of partial mandibular reconstruction with fibula grafts and implant-supported prostheses. Int J Oral Maxillofac Surg. 2013 Nov;42(11):1403-8. doi: 10.1016/j.ijom.2013.05.007. Epub 2013 Jun — View Citation

Pjetursson BE, Karoussis I, Bürgin W, Brägger U, Lang NP. Patients' satisfaction following implant therapy. A 10-year prospective cohort study. Clin Oral Implants Res. 2005 Apr;16(2):185-93. — View Citation

Pommer B, Zechner W, Watzak G, Ulm C, Watzek G, Tepper G. Progress and trends in patients' mindset on dental implants. I: level of information, sources of information and need for patient information. Clin Oral Implants Res. 2011 Feb;22(2):223-9. doi: 10. — View Citation

Rogers SN, Devine J, Lowe D, Shokar P, Brown JS, Vaugman ED. Longitudinal health-related quality of life after mandibular resection for oral cancer: a comparison between rim and segment. Head Neck. 2004 Jan;26(1):54-62. — View Citation

Rustemeyer J, Bremerich A. Patients' knowledge and expectations regarding dental implants: assessment by questionnaire. Int J Oral Maxillofac Surg. 2007 Sep;36(9):814-7. Epub 2007 Jul 2. — View Citation

Shpitzer T, Neligan PC, Gullane PJ, Freeman JE, Boyd BJ, Rotstein LE, Brown DH, Irish JC, Gur E. Oromandibular reconstruction with the fibular free flap. Analysis of 50 consecutive flaps. Arch Otolaryngol Head Neck Surg. 1997 Sep;123(9):939-44. — View Citation

Tepper G, Haas R, Mailath G, Teller C, Zechner W, Watzak G, Watzek G. Representative marketing-oriented study on implants in the Austrian population. I. Level of information, sources of information and need for patient information. Clin Oral Implants Res. — View Citation

Vayvada H, Mola F, Menderes A, Yilmaz M. Surgical management of ameloblastoma in the mandible: Segmental mandibulectomy and immediate reconstruction with free fibula or deep circumflex iliac artery flap (evaluation of the long-term esthetic and functional — View Citation

Vermylen K, Collaert B, Lindén U, Björn AL, De Bruyn H. Patient satisfaction and quality of single-tooth restorations. Clin Oral Implants Res. 2003 Feb;14(1):119-24. — View Citation

Voutilainen A, Pitkäaho T, Kvist T, Vehviläinen-Julkunen K. How to ask about patient satisfaction? The visual analogue scale is less vulnerable to confounding factors and ceiling effect than a symmetric Likert scale. J Adv Nurs. 2016 Apr;72(4):946-57. doi — View Citation

Yao J, Tang H, Gao XL, McGrath C, Mattheos N. Patients' expectations to dental implant: a systematic review of the literature. Health Qual Life Outcomes. 2014 Oct 29;12:153. doi: 10.1186/s12955-014-0153-9. Review. — View Citation

Zhu J, Yang Y, Li W. Assessment of quality of life and sociocultural aspects in patients with ameloblastoma after immediate mandibular reconstruction with a fibular free flap. Br J Oral Maxillofac Surg. 2014 Feb;52(2):163-7. doi: 10.1016/j.bjoms.2013.10.0 — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

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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