INDIAN DENTAL JOURNAL Official Publication of Society of Medical Dental & Public Health

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1 Effect of psychotherapy counseling in the satisfaction level of geriatric patients with removable prosthesis: An operator and statistician blinded randomized controlled parallel design study Dr. Abhinav Shekhar 1 Dr. Bhaskar Agarwal 2 Dr. Balendra Pratap Singh 3 Dr. Ajay Singh 4 Dr. Pooran Chand 5 Dr. Shitij Srivastava 6 Dr. Nishi Singh 7 1,6 Reader, SPPGIDMS, Lucknow, India 2 Assistant Professor, Department of Prosthodontics, King George s Medical University, UP, Lucknow, India 3 Associate Professor, Department of Prosthodontics, King George s Medical University, UP, Lucknow, India 4 Professor & Head, SPPGIDMS, Lucknow, India 5 Professor & Head, Department of Prosthodontics, King George s Medical University, UP, Lucknow, India 7 Private Practitioner, Lucknow, India Address for Correspondence: Dr. Abhinav Shekhar B -358/1 Rajajipuram, Lucknow, India. dr_05online@yahoo.co.in ABSTRACT There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomized Controlled Trial (RCT) evidence for best practice. The aim of this research was to correlate psychological counseling with the prognosis of prosthodontic treatment done for geriatric population of Lucknow, in a single-blind, randomized, parallel, controlled, clinical trial. Methods: A total of One hundred fifty edentulous patients were recruited, using published eligibility criteria, to the trial at Department of Prosthodontics, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow. These patients were randomly divided into two groups of seventy five each. One group received complete denture without psychological counseling and the other group with psychological counseling. Denture satisfaction was predicted by a measure of locus of control (the degree to which individuals feel that they control their destiny) and a questionnaire (designed to assess retention, phonetics, mastication and overall satisfaction level). The primary outcome was to compare the satisfaction level of patients receiving complete denture with counseling with those without psychotherapic intervention. Results: The following results were obtained, the mean satisfaction level of Group I was 14.29, while in Group II it was For all the items as well as for total score, the mean scores were significantly higher in Group II as compared to Group I (p<0.001). Conclusion: There is significant evidence those patients who were psychologically counseled where the ones who were more satisfied with their complete dentures. Clinical significance: Given the strength of the clinical findings within this paper, dentists should also consider other psychosocial problems being faced by the elderly population because this has a direct bearing to the Prosthodontic treatment outcome. KEYWORDS: Prosthodontics, Psychosocial, complete denture, Counseling, Edentulous, Removable prosthodontics I NTRODUCTION - The geriatric population in India (including U.P.) is growing at a faster rate. The NSSO report predicts both the share and size of elderly population is increasing over time. From 5.6% in 1961 it is projected to rise to 12.4% of population by the year The geriatric population faces a multitude of 8

2 problems including health, financial and emotional security. Prosthodontics, as a dental specialty has a frequent interaction with the geriatric population and caters to rehabilitation of oral health following teeth loss, which may range from single, multiple to complete edentulism. The treatment of choice for edentulous patients today is mainly dental implants, but inspite of that the barriers to implant treatment are well known and have been thoroughly explored in the literature. 1, 2 The problems are mainly related to the cost of treatment, fear of surgery, age of the patient and systemic conditions. Even when implants were offered free, more than one third of the patients rejected this option of choice. 3 28% of edentulous patients were found not to be suitable to receive dental implants in a clinical trial. 4 Therefore the option of conventional prosthodontics remains the staple provision for tooth replacement for many patients. The roles of both psychological and technical factors in the acceptance of complete dentures have been studied for long periods of time. 5.Though the prosthodontists are trained in rehabilitation procedures, however, there is little or, at best, a casual concern towards the other psychosocial problems being faced by the elderly population, which is important to address because this has a direct bearing to the Prosthodontic treatment outcome. This study evaluates the effect of psychotherapy counseling in the satisfaction level of geriatric patients with removable prosthesis. Presently, no study has been found in the literature regarding the same. The results of this study may be helpful in giving an indication towards the nature and extent of such problems being faced by the elderly population of Lucknow region, which in turn, will help in improving the Quality of life of the geriatric population. The primary aim for this RCT is to evaluate the effect of psychotherapy counseling in the satisfaction level of geriatric patients with removable prosthesis. The secondary objectives are 1. To assess the impact of dentures on oral health related quality of life. 2. To assess comfort, stability and chewing efficiency for dentures with or without psychotherapy counseling. METHODS This research was carried out in the Department of Prosthodontics, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow between January 2012 to December It was a single centre, operator-blind, randomized, controlled, superiority trial with parallel groups of edentulous patients with and without psychotherapy counseling. The allocation ratio was 1:1. Ethical approval was obtained through the Research Ethical committee of Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow and written informed consent was obtained from all patients. Eligible participants were edentulous adults aged 60 or over, who required complete dentures, were available for follow up and able and willing to complete the informed consent process and first time denture wearers. The patients were selected irrespective of their sex and personality and were excluded if they had an oral tumour, required an obturator, had extreme xerostomia, had a known hypersensitivity to acrylic. A total of 150 patients were recruited overall. All 150 patients were recruited from the outdoor department of prosthodontics, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow. The study group patients were divided into two equal groups of 75 each, based on random allocation as it would eliminate any bias in the primary outcome of the study. The unit of randomization was, the edentulous patients receiving complete dentures. 9

3 Random allocation was done by Simple Sequential Randomization. Group I Control Group 75 patients Complete dentures were fabricated without psychological intervention. Group II Intervention Group 75 patients - Complete dentures were fabricated with psychological intervention. Primary impressions were made using impression compound as per the standard protocol. The impressions were poued using type II gpsum product and primary casts were obtained. Acrylic, spaced, and customised impression trays with stub handles and acrylic stops were constructed for each patient. The spacing of the customised trays was achieved in the usual way of adapting a layer of denture wax over the primary cast and constructing the customised tray over the wax. 6 Where there was deep hard tissue undercut on the casts this was reduced by blocking out the undercut in wax prior to laying down the spacer. The trays were border moulded with green stick impression compound (Kerr) in the usual way 6 and the zinc oxide eugenol final impressions taken (Xantalgin, Heraeus). The master casts were poured in the dental laboratory and the casts cleaned to remove all traces of impression material. All subsequent stages of denture construction were followed in the usual manner. The quality of work was assessed by the clinician and by a second independent inspector at each step. If either the clinician or the second independent assessor felt any procedure was below an acceptable standard, the clinician repeated the work. Patients were given the dentures with instructions by prosthodontists as per the standard protocol. The clinician was blind to which patient would receive psychotherapy counseling and who would not receive any intervention. The follow up visits for both the groups were as per the standard Prosthodontic Protocol. The psychological counseling was done at two stages, first during the fabrication of complete denture and second at the denture insertion appointment. The psychological intervention was done using Nowicki-Strickland Locus of Control, which basically tells the extent to which people believe they have power over events in their lives. A person with an internal locus of control believes that he or she can influence events and their outcomes, while someone with an external locus of control blames outside forces for everything. 7 At this stage the psychologist was blinded, as he dint know which patient will be treated as control or trial group. The denture satisfaction by the patients was evaluated by another expert who was unaware of the identity of the patient group (control or trial). Evaluation was done using a denture satisfaction questionnaire at three months recall visit, which covers five denture criteria: retention of the maxillary denture, retention of the mandibular denture, ability to chew, speaking, and overall satisfaction. It is a five-point Likert-type scale, meaning that the patient had to grade his satisfaction into five grades: very good, good, medium, bad, and very bad. The primary outcome assessed was the effect of psychotherapy counseling in the satisfaction level of geriatric patients with removable prosthesis. Data was analyzed using Statistical Package for Social Sciences (SPSS) version Chi-square test and Mann-Whitney U test has been used to compare the data. A p value less than 0.05 has been considered to represent a significant difference between two groups. RESULTS The locus of control was determined by asking the patients to fill up a questionnaire. In Group I (Control Group), out of seventy five patients, 39 (52 %) patients had an external locus of control and 36 (48%) patients had an internal locus of control. In 10

4 Group II (Intervention Group) 27 (36%) patients had an external locus of control and 48 (64%) patients had an internal locus of control. DISCUSSION Oral health effects overall health of an individual. From decades, removable complete denture prosthesis has been a centre for oral rehabilitation. From prosthodontist view, a successful complete denture has always been associated with achieving good retention, stability and support. Whereas from patients point of view, it depends on mastication, phonetics and esthetics. The role of prosthodontist is to embark a bridge between his own and patients expectations, keeping in mind the limitation of soft tissue, bone and associated structures. Patients psychology plays an important role in successful complete denture therapy. This feature has been acknowledged in the literature by many authors. Dr. M.M.House recognized this psychological issue and place forward Mental Classification. He classified patients into four categories, namely, Philosophical, Exacting, Skeptical and Indifferent. There are many studies which demonstrate the satisfaction level with complete denture, expectations with complete denture, quality of life issues and 8, 9, 10, 11 many more. But, the effect of psychological counseling with the help of expert has been an ignored issue. In the present study, our aim was to establish role of psychotherapy counseling in the success of complete denture prosthesis. The study was conducted in department of SPPGIDMS with 150 patients. The study group patients were divided into two equal groups of 75 each. One group received complete dentures with psychological counseling, while the other group received complete dentures without counseling. Denture satisfaction was assessed in both the groups based on retention, phonetics, mastication and overall satisfaction. Grading scale used was very happy, happy, average, not happy, not at all happy. The following results were obtained, the mean satisfaction level of Group I was 14.29, while in Group II it was For all the items as well as for total score, the mean scores were significantly higher in Group II as compared to Group I (p<0.001). This difference could be as, psychological therapy was initiated after random distribution of samples, so the impact of therapy according to personality, gender, education and occupation of patients could not be established. This happened due to time and sample size limitation of the study. In the present study, blinding was achieved for the clinician fabricating complete denture was unaware of control/study group, psychologist, providing the psychotherapy and clinician checking the satisfaction level of patients after three months recall visit and the statistician who analyzed the data. There could be possible bias on the part of patient, who were very well aware of the study. Further long term studies with large sample size can be done which can identify the personality, gender, education and occupation beforehand and thereafter correlate with the effects of psychotherapy in such patients. CONCLUSION There is significant evidence those patients who were psychologically counseled where the ones who were more satisfied with their complete dentures. Given the strength of the clinical findings within this paper, dentists should also consider other psychosocial problems being faced by the elderly population because this has a direct bearing to the Prosthodontic treatment outcome. 11

5 Groups External locus of control Internal locus of control Group I (control) Group II =3.896; p=0.048 (S) Satisfaction related to complete dentures was measured by using a questionnaire, which consisted of five criteria, which the patient had to rate. Five point Linkert scale was used. Table -Satisfaction related to complete dentures Group I (Control) Very good/very happy (5 points) Good/happy (4 points) Medium/average (3 points) Bad/not happy (2 points) Very bad/not at all happy(1 point) A Retention(fit) of maxillary denture 10 (13.3%) 26 (34.7%) 36(48%) 3 (4%) 0 B Retention(fit) of mandibular denture 4 (5.3%) 9 (12.0%) 24 (32%) 30 (40%) 8 (10.7%) C Ability chew to 4 (5.3%) 9 (12.0%) 24 (32.0%) 30 (40%) 8 (10.7%) D Speaking 4 (5.3%) 15 (20.0%) 26 (34.7%) 28 (37.3%) 2 (2.7%) E Overall satisfaction 4 (5.3%) 9 (12.0%) 24 (32.0%) 30 (40.0%) 8 (10.7%) 12

6 A. Patient satisfaction related to fit (retention) of the upper denture 10 /75 (13.33%) Patients were very happy 26/75 (34.66%) Patients were happy 36/75 (48%) Patients had average satisfaction 3/75 (4%) Patient were not happy 0/75 (0%) Patient were not at all happy INDIAN DENTAL JOURNAL Pie chart 1- Group I Patient satisfaction related to fit (retention) of the upper denture retention of maxillary denture B. Patient satisfaction related to fit (retention) of the lower denture 4 /75 (5.33%) Patients were very happy 9/75 (12%) Patients were happy 24/75 (32%) Patients had average satisfaction 30/75 (40%) Patient were not happy 8/75 (10.66%) Patient were not at all happy Pie chart 2- Group I Patient satisfaction related to fit (retention) of the lower denture retention of mandibular denture

7 C. Patient satisfaction related to Ability to chew 4 /75 (5.33%) Patients were very happy 9/75 (12%) Patients were happy 24/75 (32%) Patients had average satisfaction 30/75 (40%) Patient were not happy 8/75 (10.66%) Patient were not at all happy Pie chart 3- Group I Patient satisfaction related to ability to chew Ability to chew D. Patient satisfaction related to Speaking 4 /75 (5.33%) Patients were very happy 15/75 (20%) Patients were happy 26/75 (34.66%) Patients had average satisfaction 28/75 (37.33%) Patient were not happy 2/75 (2.66%) Patient were not at all happy Pie chart 4- Group I Patient satisfaction related to Speaking Ability to Speak

8 E. Patient satisfaction related to Overall Satisfaction 4 /75 (5.33%) Patients were very happy 9/75 (12%) Patients were happy 24/75 (32%) Patients had average satisfaction 30/75 (40%) Patient were not happy 8/75 (10.66%) Patient were not at all happy Pie chart 5- Group I Patient satisfaction related to Overall Satisfaction Overall Satisfaction Group II (Intervention Group) Very good (5 points) Good (4 points) Medium (3 points) Bad (2 points) Very bad (1 point) A Retention(fit) of maxillary denture 21 (28.0%) 36 (48.0%) 16 (21.3%) 2 (2.7%) 0 B Retention(fit) of mandibular denture 20 (26.7%) 22 (29.3%) 32 (42.7%) 1 (1.3%) 0 C Ability to chew 19 (25.3%) 25 (33.3%) 31 (41.3%)

9 D Speaking 29 (38.7%) 30 (40.0%) 16 (21.3%) 0 0 E Overall satisfaction 19 (25.3%) 24 (32.0%) 32 (42.7%) 0 0 A. Patient satisfaction related to fit (retention) of the upper denture 21 /75 (28%) Patients were very happy 36/75 (48%) Patients were happy 16/75 (21.33%) Patients had average satisfaction 2/75 (2.66%) Patient were not happy 0/75 (0%) Patient were not at all happy Pie chart 1- Group II Patient satisfaction related to fit (retention) of the upper denture B. Patient satisfaction related to fit (retention) of lower denture 20 /75 (26.66%) Patients were very happy 22/75 (29.33%) Patients were happy 32/75 (42.66%) Patients had average satisfaction 1/75 (1.33%) Patient were not happy 0/75 (0%) Patient were not at all happy 16

10 Pie chart 2- Group II Patient satisfaction related to fit (retention) of lower denture Fit of lower denture C. Patient satisfaction related to ability to chew 19 /75 (25.33%) Patients were very happy 25/75 (33.33%) Patients were happy 31/75 (41.33%) Patients had average satisfaction 0/75 (0%) Patient were not happy 0/75 (0%) Patient were not at all happy Pie chart 3- Group II Patient satisfaction related to ability to chew Ability to chew D. Patient satisfaction related to speaking 29 /75 (38.66%) Patients were very happy 30/75 (40%) Patients were happy 16/75 (21.33%) Patients had average satisfaction 0/75 (0%) Patient were not happy 0/75 (0%) Patient were not at all happy 17

11 Pie chart 4- Group II Patient satisfaction related to speaking INDIAN DENTAL JOURNAL E. Patient satisfaction related to overall satisfaction 19 /75 (25.33%) Patients were very happy 24/75 (32%) Patients were happy 32/75 (42.66%) Patients had average satisfaction 0/75 (0%) Patient were not happy 0/75 (0%) Patient were not at all happy Pie chart 5- Group II Patient satisfaction related to overall satisfaction 18

12 Comparison of Itemized Scores as well as Total scores between two groups Group I (n=75) Group II (n=75) Statistical significance Item Mean SD Mean SD z' p' Retention(fit) of maxillary denture <0.001 Retention(fit) of mandibular denture <0.001 Ability to chew <0.001 Speaking <0.001 overall satisfaction <0.001 Total <0.001 Mann Whitney U test For all the items as well as for total score, the mean scores were significantly higher in Group II as compared to Group I (p<0.001). 19

13 REFERENCES 1. Müller F., Salem K., Barbezat C., Herrmann F.R., Schimmel M. Knowledge and attitude of elderly persons towards dental implants. Gerodontology. 2012;29: Ellis J.S., Levine A., Bedos C., Mojon P., Rosberger Z., Feine J. Refusal of implant supported mandibular overdentures by elderly patients. Gerodontology. 2011;28: Walton J.N., MacEntee M.I. Choosing or refusing oral implants: a prospective study of edentulous volunteers for a clinical trial. International Journal of Prosthodontics. 2005;18: Walton J.N., MacEntee M.I. Screening and enrolling subjects in a randomized clinical trial involving implant dentures. International Journal of Prosthodontics. 2008;21: Wass M J. The influence of clinical variables on patient satisfaction with complete dentures. Journal of Prosthetic Dentistry 1960; 63: Basker R.M. 4th ed. Blackwell Publishing Company; Oxford: Prosthetic treatment of the edentulous patient. 7. Generalized expectancies for internal versus external control of reinforcement, julian b. Rotter, Psychological Monographs: General and Applied, Vol. 80, No. 1, Whole No. 609, Marinus AJ. Determinants of dissatisfaction with dentures: A multiple regression analysis. The Journal of Prosthetic Dentistry, 1990; 64(5): Marinus AJ. The influence of psychologic factors on patient satisfaction with complete dentures. The Journal of Prosthetic Dentistry, 1990; 63(5): Fenlon MR, Sherriff M. An investigation of factors influencing patients satisfaction with new complete dentures using structural equation modeling. Journal of Dentistry, 2008; 36(6): Fenlon MR, Sherriff M. Investigation of new complete denture quality and patients' satisfaction with and use of dentures after two years. Journal of Dentistry, 2004; 32(4):

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