Cost-benefit analysis of dental implant-supported overdenture treatment in head and neck cancer patients.

AIM: To conduct a cost-benefit analysis of dental implant supported overdenture treatment in head and neck cancer patients.

 PRIMARY OBJECTIVE:

1. To find the Cost in rupees needed for each point gain in the quality of life with dental implant-supported overdenture treatment in both native jaw and free fibular flap reconstructed jaw.

  SECONDARY OBJECTIVES:

1. To measure Quality-adjusted life years (QALYs) by assessing change in the oral health-related quality of life using the Oral health impact profile questionnaire (OHIP-14) before fabrication of prosthesis and 3 ± 1 months after placement of overdenture.
2. To evaluate the change in functional outcome using mixing ability test before fabrication of prosthesis and 3 ± 1 month after placement of overdenture.
3. To evaluate patient-perceived treatment satisfaction using Liverpool oral rehabilitation questionnaire (LORQOLv3) before fabrication of prosthesis and 3 ± 1 month after placement of overdenture.

STUDY METHODOLOGY

1. Patients who satisfy the aforementioned inclusion criteria will be approached for study participation and accrued after they provide written informed consent for the present study. which shall be taken from the patient before fabrication of prosthesis and patients shall be given 24 hours to decide.

2. Dental implants are standard care offered at Tata Memorial Hospital where implants are either placed primarily or secondarily.

3. For patients who has underwent adjuvant radiotherapy, dental implant treatment is done 1 year    after completion of radiation therapy as per institutional policy.

4. Implants are loaded according to institute protocol i.e., receive overdenture prosthesis after 3 and 6 months in non- irradiated and irradiated patients respectively, to allow sufficient time for the implants to Osseo integrate

5. Patient’s relevant demographic characteristics will be noted. Necessary information shall be collected from Patient’s files and hospital electronic medical records/interview of patients.

6. Quality of life data i.e., Oral health impact profile-14 questionnaire and Liverpool oral rehabilitation questionnaire version 3 will be recorded before prosthesis fabrication and 3 ± 1 months after completion of treatment.

7. Patients’ chewing or masticatory performance will be evaluated using mixing ability test at before prosthesis fabrication and 3 ± 1 months after completion of treatment. Test specimens will be prepared from commercially available chewing gums (pink and blue). Strips of 30 mm in length will be cut from both colors and manually stuck together and the test strips which will be chewed on by the patient for a total of 20 strokes. The number of strokes will be counted by the subject and the experimenter. Instructions will be given to chew on the right or left sides, both, as preferred (habitual chewing), and to terminate in a closed mouth position thereafter open the mouth to enable the experimenter to remove the gum. The degree to which the colors were mixed will be quantified and scored by visual assessment using color and shape rating scales.

8. Direct expenses shall be calculated by assimilating all expenses incurred from the time of implant surgery till the fabrication of prosthesis for implant treatment exclusively.

Variables to be estimated

Cost in rupees for point gain in quality of life after dental implant-supported overdenture treatment and QALY scores.

Quality of life based on (OHIP-14 Questionnaire), Liverpool Oral Rehabilitation Questionnaire (LORQv3) and Functional outcome using chewing ability test scores.

Analysis of the variables-

Descriptive statistical measures will be used to summarize the data. Categorical data will be expressed in frequency and proportions, normality of continuous data on cost, and quality of life scores will be tested using Shapiro-Wilk test for normality. Normally distributed data will be expressed using mean and standard deviation, and non-normally distributed data will be expressed using median and interquartile range.

The mean and standard of cost in rupees needed for each point gain in the quality of life point after dental implant-supported overdenture treatment in native and free fibular flap reconstructed jaw will be calculated.

The scores on Quality of life (OHIP-14 Questionnaire), Liverpool Oral Rehabilitation Questionnaire (LORQv3) and Functional outcome using chewing ability test scores will be collected before prosthesis fabrication and 3 Â± 1 months after dental implant-supported overdenture treatment and compared using Student’s t-test or Wilcoxon’s Signed Rank test in both the groups based on the compliance or non-compliance to the parametric tests assumptions.