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Comparative evaluation of Health-related quality of life (QoL) after maxillectomy with and without rehabilitation using obturator prosthesis

Dr Sweta Gajanan Pisulkar1, Dr Ashok Janardhan Pakhan2, Dr Rajiv Dharampal Bhola3, DrGajananLaxman Pisulkar4, DrHetal Satish Purohit5 DrRohit Ashok Mistry6

1: MDS, PhD (Prosthodontics and Crown & Bridge), Fellow (Maxillofacial Prosthodontics), Associate Professor, Department of Prosthodontics And Crown & Bridge, SharadPawar Dental College, Datta Meghe Institute of Medical Sciences, Sawangi (M),Wardha, India.

2: MDS (Prosthodontics and Crown & Bridge), Professor, Department of Prosthodontics And Crown & Bridge, SharadPawar Dental College, Datta Meghe Institute of Medical Sciences,

Sawangi (M), Wardha, India

3: MDS (Prosthodontics and Crown & Bridge), Assistant Professor, Department of Prosthodontics And Crown & Bridge, SharadPawar Dental College, Datta Meghe Institute of

Medical Sciences, Sawangi (M), Wardha, India

4: MS (Orthopedics), Professor, Acharya VinobaBhave Rural Hospital, Datta Meghe Institute of Medical Sciences, Sawangi(M), Wardha, India.

5: Postgraduate Resident, Department of Prosthodontics and Crown & Bridge, SharadPawar Dental College, Datta Meghe Institute of Medical Sciences, Sawangi(M), Wardha, India.

6: Postgraduate Resident, Department of Prosthodontics and Crown & Bridge, SharadPawar Dental College, Datta Meghe Institute of Medical Sciences, Sawangi(M), Wardha, India

ABSTRACT

Purpose: The study in comparison evaluated the health-related quality of life of patients post maxillectomy in patients with and without obturator prosthesis. Methodology: The prospective study was conducted in the Department of Prosthodontics in SharadPawar Dental College. The patients operated for maxillary resection along with Prosthodontic treatment and obturator prosthesis, and flap reconstructions were supposed to be included in the following cross-sectional study in last two years. Results: The social and demographic along with medical characteristics of 24 patients interviewed. The impact of selected variables in the aspects of demography and treatment on patient‟s Quality of Life were evaluated. A total of 15 (68.8%) patients were male and 9 (31.2%) female in mean age range of 57.6±10.7 years of age (ranging 34–82 years) were evaluated. Squamous Cell Carcinoma was one of the most frequently histologically diagnosed cases i.e. 52% of total patients.Second most frequently occurring is adenocarcinoma i.e. 16.6% of total cases, (5/30) and the third most frequently occurring diagnosis was adenoid cystic carcinoma i.e.

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10% of the total occurring cases, (3/30). The overall quality of life post rehabilitation of prosthesis with the help of obturators was on an average found to be 54±22.9%. Whereas the patients of age group between 50-59 years of age showed lowest ratings of 47% when compared with the patients of other age groups. Conclusion: Both age groups showed similarity in the outcomes, which were subjective, and hence a larger longitudinal study will be required to evaluate and establish these relationships.

Keywords: Obturator, Oral Health related Quality of Life, Oral cancer, Prosthetic rehabilitation, Nutrition, squamous cell carcinoma, health, psychological recovery, speech, deglutition, individual perception

INTRODUCTION:

The advent of the term Quality of Life dates back to the time of the great Greek philosopher Aristotle. At that time quality of life was related to happiness. However with complexity in understanding, thought processes and segregation of various aspects of life the term now incorporates a variety of factors.To put in simplest way it is the feeling of a well-being by an individual. The WHO defines quality of life as “The Individual's Perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns”(1)

Not only medicine, religion but also in context to economics as well as politics quality of life always plays an important consideration. The terminology „quality of life‟ frequently refers to assess contributing factors to live in a society or it can also be used for the society's individuals Quality of life which comprises physical related health along with personal conditions like wealth, conditions to live, interpersonal relationships, social activity, functional activities and pursuits, as well as economical influences.

3

In the literature, end points such as reappearance and survival rates are evaluating tools necessary for assessing the therapeutic efficacy.Interventions in oncological related patients where satisfaction of the patients is not usually given utmost importance. In recent, the acknowledgement of the multidimensional influence of tumors of maxillofacial region on a patient's life has led to an increased focus and importance in the quality of life of these patients.

4

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Studies evaluating the Quality of life of patients who are treated with defects in the maxillofacial region followed by prosthodontics therapy comprising ofobturator prostheses are seldom. Till date little information is available regarding the comparison between prosthetic obturation and reconstruction wit free flap.

5,6

In the recent years micro-vascular free tissue transfer surgical methodsare established, but it‟ still a matter of controversy to reconstruct themaxillectomy defects optimally.There are various deciding factors like age, patient‟s medical history, and defect size also the surgical skills for reconstruction or obturation.

7–9

Definitive correction is provided by surgical reconstruction of the flap for the defective oro-nasal communication and, is linked with increased procedural time and the chances of donor morbidity.6

Mostly surgical reconstruction does not accomplish the dental rehabilitation instead obturator fabrication decreases the procedural time and offers immediate dental rehabilitation. Removal of the obturator prosthesis provides easy visualization and recurrence rate can be detected.

10–12

Obturation is still a privileged treatment option post maxillectomy and describes the comparison between the groups rarely. Reconstruction and restoration of the defect of the resected maxilla, distorted facial contours is most important. Patient compliance remains important and difficulties in handling the obturator also the impaired functioning like mastication, speech these deficit leads to patient dissatisfaction.

4,10,13

The literature states no significant difference between the prosthetic rehabilitation with and without obturator prosthesis.

5,6

MATERIAL AND METHODOLOGY:

Patients:

This prospective study was conducted in the department of prosthodontics and crown and bridge in SharadPawar Dental College, DMIMS. The study group involved patients operated for maxillary resection and prosthodontic rehabilitation, and flap reconstruction..A cross sectional study was planned to examine all the patients reported to department of prosthodontics in last two years.Informed written consent was obtained from the participants included in study. A sum total of 24 patients were interviewed and assessment was carried out using questionnaire.

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Inclusion criteria for the study– comprising of patients with various types of post- maxillectomy defects.

Exclusion criteria – patients with any other extra-oral or intraoral defect.

Prosthesis:

All obturator prosthesis was confirmed for the obturator fabrication in Department of Prosthodontics and Crown and Bridge, SPDC, DMIMS (DU).

The questionnaire format used was of Hindi type for European Organization for Research and Treatment of Cancer, Head and Neck version 1 of Quality of Life Questionnaire (EORTC QLQ-H &N 35).Nine major categories in questionnaires of OFS inclusive of, satisfaction in relation to facial appearance, capability of speech, public speaking ability, leaks associated with intake of solid and liquid diet, dryness of oral cavity, obturator insertion, chewing or eatinghabits ,interactions socially as well as with family, and overall OFS were scored. Usage of the Mathematical value from 0 to 100 for each response.

Where score 0 denotes maximum distress and dissatisfaction whereas score of 100 denoted satisfied in context to functioning and aesthetics (ANNEXURE II). Questionnaire based on their personal experience was filled by the patient twice, one before the surgical intervention and other 2 weeks post definitive prosthesis insertion. The study aimed to comparatively assess the health related quality of life after rehabilitation with and without obturator prosthesis in post-maxillectomy cases.

Observation and results:The study involved in total 15 (68.80%) male and 9 (31.30%) female patients with mean of 57.81±9.5years of age. They chiefly had no primary/secondary schooling (55%, 17/30).Retired group of patients(70%, 21/30) who experienced the treatment as resection, loss of their occupational status leading to unemployment as an effect of disease and 30% (9/30) persisted in occupation. The frequently occurring recurrentdiagnoses on the basis of histological reports observed were of squamous cell carcinoma (52%, 16/30), adenocarcinoma (16.6%, 5/30) and adenoid cystic carcinoma (10%, 3/30). Global QoL after the rehabilitation using prosthesis reported as 54±22.9% on average. Lowermost scores (47%) were witnessed in patients aged 50–59 years (n=13), in comparison with study groups involving other age groups (Table- 2).

QoL in female patients was slightly better as compared to males(female group 55%, male

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group 54%).QoL of obturation prosthesis was not significantly associated to the parameters like gender(p=0.092), size of tumor(p=0.123), age(p=0.828) in divergence to presence of pain(p=0.002)the QoL positively correlated to the extensiveness of therapy.

Only the results of surgery alone gave positive outcome and average rating in comparison to the combination therapy of radiation, chemotherapy and surgery (p=0.042). Evaluation of QoL also had an impact and association with classification of the maxilla associated defects(p=0.793).Gradation of the impairment was in negative co-relation with the QoL.The gradation of impairment of speech (p=0.005), intake(p=0.001), xerostomia or dryness of mucosa (p=0.030), or socialappearance (p=0.001) had a substantial effect on the quality of life post prosthodontic rehabilitation with obturator prostheses (Table-3).

Public exposure post tumor therapy declined to 52% (16/30) of patients and stayed unaffected in 48% (15/30) of patients. Even though quality of life declined in patients with reduced social exposure the variance between the study group remained statistically insignificant (p=0.092). The main reasons for the decline in public exposure were problems associated with intake 75% (12/16), speaking 44% (7/16), or impairment of facial appeal 38% (6/16). QoL had significant value of association with the proper functioning of the prosthesis (p=0.002).

Discussion:

The influence of maxillofacial tumors on the quality of life of the patients with defect has been recognized. The earlier researches were directed towards the recurrence of cancer and curative potential of a particular therapeutic modality.18 over a period of time psychological aspect of such patients was highlighted and need was recognized for studies relating to quality of life of such patients. Numerous studies have come up for assessment of quality of life of cancer patient17 but studies relating to maxillectomy rehabilitated with obturator remain sparse. The present study is a step in the same regard so that quality of life and the effectiveness of obturator therapy can be assessed in the Central India population. QoL Cancer patient‟s psychologically well-being along with vitality in these recent years have gained the focus in affecting QoL and helps in evaluating the therapeutic success. Evaluation of the QoL in patients operated for maxillary resection followed by prosthetic rehabilitation. The limitation of the study done was inclusion of small sample size as the cases operated for maxillectomy followed by prosthesis rehabilitation are few

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and increased mortality. 10 patients were interviewed in the study by Rogers et al,

6

, Hertrampfet al,

18

17 study group patients, I et al,

4

42 study group patients and K et al,

13

47 patients. Numerous studies assessed the QoL through questionnaireCore 30 (QLQ- C30) used the European Organization for Research and Treatment of Cancer (EORTC) in the cancer patient group.

15–18

Selection bias in context to free tissue reconstruction treatment modality is respected while evaluating the quality of life of study group patients operated for maxillofacial defects rehabilitated with prosthodontic therapy with obturator prostheses. Patients who did not opt for obturator prosthesis permitted the authors to assess the effect of an obturator prosthesis and quality of life distinctly. Obturator prosthesis was given to the operated patients at the author‟s hospital, excluding the chance of gaining an adequate evaluation amongst group of patients. K et al. used standards of the Mental Health Inventory (MHI) in assessment of the alteration of their data at large among the community .

13

An average 54±22.9% of global quality of life after prosthodontic therapy with obturator prostheses was observed. An average of 66% for men and 63% for women, of the German population data reference respectively.

18

The results mentioned in the study are not in direct comparison as varied tests were used for assessment of QoL but supported by the data byHertrampfet al,

18

and stated 61% quality of life. Irish et al,4

proved quality of life equivalent or better in maxillectomy patients rehabilitated with obturator prostheses as compared to chronic disease populations .K et al,

13

investigated and reported favorable psychosocial adoption with the obturator prosthesis and adjusted well in function. The resultsexplains that there was no correlation between obturator functioning and QoL. In contrast, patients‟ rankings with defect of class I remained beneath the rankings of patients with IIIb or IVb defects. Brown et al.

5

assessed quality of life results of 16 participants with Class I and II a defects in 14 participants in the study group in comparison with patients of Class II b plus defects. In the Class I and II a group, 8 participants in the study group who were treated using reconstruction and 8 underwent obturation, and in the Class II b plus group 11 participants in the study group who were treated using reconstruction and 3 underwent obturation. A significantly lesser collective score between Class I and II a defects in comparison with Class II b plus was recorded.

Although speaking ability and eating recorded lesser (but not significantly), averages for the defect of larger size, also distortion of the features, swallowing, and shoulder function

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presented remarkably alike results. Varied methods of rehabilitation showed no significant differences when compared amongst groups. The authors in conclusion reported QoL influences the complexities associated with methods of rehabilitation as the defects are extensive. The extent of the therapy influences significantly on the quality of life. H and K

19

scrutinized 1411 DOESAK questionnaires from patients suffering from oral cancer in a retrospective multicenter study. Whiledysfunctioning and dissatisfaction of the patients undergoing radiotherapy was higher in comparison with patients treated with surgery, a significant impact on the quality of life was not observed. No significant association between the two factors of subjective feelingand the dosage of radiotherapy was proved. It is presumed that patients undergoing maxillectomy receiving supplementary radiation and chemotherapy as, larger sized tumor are at a greaterrisk of recurrence and thus have a tendency tohave more distress of the future or being depressed this negatively impacts on the quality of life. Improved QoL has been associated with good obturation. 4,6,13,18

The outcome of the existing examination supports this record, but other factors also has an impact on QoL which are undiscovered.4

Results of the study approves the problems classically linked with prostheses rehabilitation are dysfunctioning of speaking ability (hyper-nasality type of speech), eating , swallowing, leak and associated pain. Pain also causes decline in quality of life in maxillectomy operated patients. Hertrampfet al, 13

and Rogers et al, 6

identified significantly additional patients having maxillofacial defects post prosthodontic rehabilitation with obturator , complains of from pain on comparing it with control group. Significant reduction in quality of life was noticed in the present study where comparison was made between the study group patients with and without pain even though only 25% analgesics regularly. Post-operative resected maxilla patients denied appearing socially for any programs, meetings due to the discomfort associated while functioning with the organs associated. Good functioning of the obturator prosthesis is directly correlated to social activity and acceptance of the individual. According to I et al,4

and K et al,13

studies report that patients suffering from increased difficulty from usage of the prosthesis also lead to depression, emotional disturbances and disease impact.

Rehabilitation using obturator prosthesis has proven to be adequate for managing the maxillary defects, yet on verification it lacked advantages with statistical significance.R et al, 6

and Brown et al, 5

on evaluation in post maxillectomy treated patients with

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obturator prosthesis or reconstruction resulted in no statistical difference in significance amongst both the groups. Assessment of Quality of life plays a significant role in patients with comorbid conditions.21-25

Conclusion:

The treatment modality for resected maxilla which proves to be adequate and optimum is Reconstruction therapy by means of obturator prostheses.Verification of the hypothesis stating the comparison on basis of QoL between the normal population and patients treated with obturation by the outcome was done in the existing study. The significance of optimum functioning of the prosthesis highlighted by the observations of the existing study and which correlated and confirmed the observations with the records mentioned in the literature.

The importance of good functioning of the obturator prosthesis for quality of life was underlined by the findings of the present study and confirmed the results of similar studies.

To overcome shortfalls of obturator prosthesis in context to function, data and psychosocial support pre and post-surgery, repetitively stepwise interpretation of the therapy, adequate instruction use of obturator, routine care should be imparted to maxillectomy operated patients. Future investigation on substitute reconstruction methods, such as the application of regenerative concepts using stem cells may facilitate to overcome the problems typically linked with obturator prostheses or free flap reconstruction and will additionally improvise patient‟s quality of life after maxillectomy in near future.

Already known on this topic:

 The Central India region being the capital of oral squamous cell carcinoma there is a rapid increase in the incidence and thereby the management of such conditions leads to extensive surgeries.

 Rehabilitation of patients with oral carcinomas leads to resection of the affected region for instance, maxilla along with associated structures which in turn might affect the quality of life.

 There are various treatment modalities in context to management of these cases, namely; Reconstruction technique using free flap or Prosthetic rehabilitation using the obturator prosthesis

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What this study adds:

 There is very little evidence in literature regarding the effects of surgical resections on overall quality of life and thus there this study was undertaken to determine the effects of the rehabilitation on the overall quality of life.

 Quality of life gets affected in patients who do not opt for prosthetic rehabilitation as various factors like phonetics, aesthetics and mastication which is of utmost importance is impaired leading to risk of malnutrition. Thus rehabilitating these defects enhances the oral health related quality of life

 A generalized standard operation protocol has to be formulated by the multidisciplinary team for management of these defects by the prosthetic rehabilitation treatment which will enhance the form and function of the prosthesis restoring back the loss, thereby enhancing the overall health related quality of life.

Competing interests

The authors declare no competing interest.

Acknowledgements (if any)- none Tables :

Table 1: Patient information

Table 2: Medical characteristics of patients and their influence on HRQOL (N=24)

Table-3: Scores of specific categories in OFS Questionnaire

Table 4:Comparative evaluation of health-related quality of life post- maxillectomywith and without obturation type rehabilitation

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Tables:

Table 1:

Patient characteristics(N=24) N (%)

Gender

Male Patients 15(68.80)

Female Patients 9(31.30)

Age (years)

Mean age group 57.81±9.5

Range of age 39-72

Less than 60 13(56.30%)

More than 60 11(43.71%)

Status of education of the patient

Educated patient 9(31.24)

Uneducated patients 15(68.74)

Employment status

Retired 15(68.80)

Not retired 9(31.24)

Therapy

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Surgical 4(12.5)

Surgical+ Radiotherapy 14(62.51)

Surgical+ Radiotherapy+Chemotherapy 6(25)

Table 2:

Scales N (%) QOL

Mean ±SD

p value

Total participants 24 (100) 59.8±3.3%

Male 15(68.80%) 59.41±3.3%

0.325

Female 9(31.30%) 61.2%±4.4%

Age<60 13(56.30%) 60.07±3.09

0.91

Age>60 11(43.71%) 59.74%±4.8

Educated patients 15(68.74) 55.3±2.21

0.001

Uneducated patients 9(31.24) 62.04±2.03

Surgical therapy 4(12.5) 64.76±1.21

0.006 Surgical+ Radiotherapy 14(62.51) 60.96±2.02

Surgical+

Radiotherapy+Chemotherapy

6(25) 54.8±2.36

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Table 3:

Category Scoring*

(lower- higher)

Best observed score

Worst observed

score Score

Satisfaction in relation to facial

appearance 0-100 69 40

52.7±10.8

Speech 0-100 86 35 67.13±12.02

Speech- public speaking abiity 0-100 74 50 58.74±9.76

Swallowing-leaks associated with

intake of liquids 0-100 76 45

62.19±7.51

Swallowing- leaks associated with

intake of solids 0-100 81 55

67.81±6.07

Chewing/eating habits 0-100 69 35 56.9±8.90

Saliva-dryness of oral cavity 0-100 84 45 65.61±9.11

Obturator insertion 0-100 71 40 54.8±11.7

Interaction with family and

socially 0-100 66 34

51.8±9.4

Overall OFS score 0-100 66.5 52.21 60.01±3.69

Table 4:

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ITEM NO

DESCRIPTION BEFORE

OBTURATOR PROSTHESIS

AFTER

OBTURATOR PROSTHESIS

SIGNIFICANCE OF CHANGE

Mean SD Mean SD p

1 Satisfaction with

facial appearance

1.77 0.76 1.05 0.63 0.022

2 Speech 1.80 0.54 1.30 0.03 0.004

3 Speech-ability to

speak in public

1.27 0.72 1.11 0.33 0.001

4 Swallowing-leakage with liquids

1.79 0.61 2.64 0.43 0.000

5 Swallowing-leakage with solids

1.23 0.53 1.90 0.75 0.003

6 Chewing/eating 1.43 0.51 2.66 1.12 0.005

7 Saliva-dryness of

mouth

1.20 0.99 2.36 1.79 0.000

9

Social family

1.43 0.51 2.66 1.12 0.005

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interaction

10 Overall OFS score 1.77 0.76 1.05 0.63 0.022

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39–45. https://doi.org/10.1016/j.oraloncology.2019.04.009.

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