European Journal of Cardiovascular Medicine

Total tooth loss or edentulism is a severe oral disorder, most common in the aged, and impacts general quality of life by disturbing chewing, speech, and appearance [1]. Complete dentures remain the most sought-after prosthetic treatment among totally edentulous individuals and provide functional and psychological rehabilitation [2]. Complete denture adaptation is often inadequate as primary wearers experience discomfort, mastication difficulty, excess salivary flow, speech disturbance, and psychological morbidity [3]. Individual adaptation is a dynamic process and is influenced by the age, gender, oral anatomy, neuromuscular coordination, and previous experience of the individual with dentures [4].

The comfort and satisfaction of complete denture wearers are determined by a variety of factors like the fit, occlusion, and retention of the prosthesis, as well as patient-related factors including pain tolerance, motivation, and adaptability [5]. Studies have shown that initial discomfort is normal, but adaptation tends to be progressive after a few weeks to months [2, 6]. Chewing efficiency and intelligible speech improve with time, and overall comfort and satisfaction are achieved [7]. Despite advancements in prosthodontics, a large number of patients who are wearing dentures for the first time have trouble adapting, and this causes frustration and even abandonment of the prosthesis [8]. It is critical that prosthodontists have an understanding of the adaptation process to improve their ability to educate their patients, develop better treatment planning, and produce superior long-term results [9].

High levels of older persons require complete dentures due to untreated oral infections, periodontal disease, and the scarcity of dental treatment in Bangladesh [10]. However, limited studies exist assessing the adaptation and comfort of novice complete denture wearers in the Bangladeshi population [11]. Cultural and dietary lifestyles, oral hygiene behavior, and access to healthcare contribute to the acceptance and success of dentures, and thus it is important to investigate patient experiences in this regard [12, 13].

The current study aimed to evaluate first-time complete denture wearers' adaptation process and comfort levels over a six-month period. By measuring patient-reported difficulties, adaptation time, and satisfaction, the study seeks to have an understanding of denture wearers' current difficulties and factors for successful adaptation. Findings can be used to improve prosthetic rehabilitation strategies and patient counseling, which will enhance the quality of edentulous patients' lives in Bangladesh.

Study Design: Prospective observational study. Study area: MNR medical college and hospital, Fasalwadi, Sangareddy , ENT OPD. Study Period: one year. Sample size: The study consisted of a total of 50 subjects. The sample size for the present study was estimated based on the study conducted by Shah et al10 where success rate for patients with placement of stent was 91.66% using this parameter sample size for the study was calculated using the formula Z at 95% CI = 1.96 P = 91.6% Loss to follow up = 10% D= 8% Using this the sample size was estimated to be 50 Sampling Technique: Simple random sampling method. Inclusion Criteria: All patients with recurrent epiphora or dacryocystitis and have been diagnosed to have nasolacrimal duct obstruction not fulfilling the exclusion criteria. Exclusion Criteria: 1. Watering due to causes other than the naso lacrimal duct obstruction 2. Patients with lacrimal trauma or lacrimal sac tumours. 3. Patients with uncontrolled hypertension and diabetes mellitus. 4. Patients unwillingness for EnDCR surgery and those who are not fit for surgery 5. Revision EnDCR and failed external dacryocystorhinostomy. Ethical consideration: Institutional Ethical committee permission was taken before the commencement of the study. Methods of Data Collection: The present study is a prospective study where 50 patients with recurrent epiphora or dacryocystitis and have been diagnosed to have nasolacrimal duct obstruction were included. Informed consent was taken from all the study participants. Study included fifty patients, divided into two groups of 25 patients each. Group A consists of patients who underwent endoscopic DCR with silicon stent and group B consists of patients who underwent endoscopic DCR without stent Preoperative evaluation: The pre-operative evaluation consisted of a standard ophthalmic and otolaryngologic examination, lacrimal probing followed by irrigation and Nasal Endoscopy. The nasal cavity was examined and the need for additional nasal surgery (i.e., septoplasty, middle turbinate reduction) also was determined pre-operatively. Randomization of patients into two groups was done on the basis of simple randomization technique by computer generated token system after their Pre-anesthetic checkup. 25 patients underwent endoscopic DCR with Prolene stenting and 25 without stenting Postoperative care and follow up: Broad-spectrum oral antibiotics were given for 5 days together with Ofloxacin eyedrops for 7 days. Nasal saline drops were also prescribed after pack removal for 4 weeks. All patients were followed up till 3rd month Post operatively Prolene stent was removed at 6 weeks. At every visit resident assessed subjective symptom of epiphora as No epiphora (0), Minimal epiphora (1), Moderate epiphora (2) and Severe epiphora (3), Grade 0, 1 and 2 were classified as success and 3 as a complete failure. While anatomical patency was assessed by lacrimal syringing under endoscopic guidance as patent and not patent. Statistical analysis: Data Entry was done using Microsoft excel 2013 and analysis done using SPSS V 16. Qualitative data was expressed in frequencies and percentages and Quantitative data in mean and standard deviation. Parametric tests include Unpaired t test for intergroup comparison was used. Paired t test for intragroup comparison was used. Bar diagrams and pie chart were used to represent the data. p value of <0.05 was considered statistically significant.

Table 1: Age Distribution

In our study of 50 cases age of the patients ranged from 24-81 yrs with most of the patients in age group of 41-50 yrs (30% N=15, 9 in group A and 6 in group B). The mean age of presentation is 49.18 yrs.

Table 2: Sex incidence

In our study 82% of the patients are females. (N=41, 20 in group A and 21 in group B) and 18% are males (N=9, 5 in group A and 4 in group B).

Table 3: Laterality

In our study 52% of the cases presented with disease on left side. (N= 26, 12 in group A and 14 in group B), 42% (N=21 11 in group A and 12 in group B) had disease on the right side and 6% (N= 3, 2 and1 in group A and group B respectively) had the disease bilaterally.

Table 4: Mode of presentation

In our study majority of the patients (86%) presented with chronic dacryocystitis and 6% (N=3, 2 in group A ,1 in group B) presented with mucocele and 8 % (N=4, 2 in each group) presented with pyocele. Fishers exact test p=0.999 NS, the presence of pyocele or mucocele did not affect the results.

Table 5: Syringing results at 1st, 6th and 10th week.

Objective analysis was done by syringing, in group B patients it was found to be patent in all cases N=25 (100%).  At 6th week in group B syringing was patent in 88%(N=22) and non-patent in 12%(N=3) of cases. At 10 weeks syringing in group A was patent in 23(92%) and non-patent in 2(8%) of cases. In group B syringing patency was seen in 22 (88%) and was non patent in 3(12%) of the cases.

Table 6: Symptomatic relief

At 1st week (table 6), all the cases reported a complete symptomatic relief 100%(N=40). At 6th week,90%(N=36) of cases reported complete relief and 2.5%(N=1) reported partial relief,7.5%(N=3) cases reported no relief of symptoms. At 10th week complete relief from epiphora was reported by 92.5% (N=37) and no relief of symptoms in 7.5%(N=3).

Table 7: Results after 3 months

The overall success results at three months (table 7, figure 22) are 88%, closure of the rhinostomal opening was seen in two cases which led to failure and in another patient, there was fibrosis at the rhinostomal opening which led to failure. 

Table 8: Complications

There were no major surgical complications (table 8 figure 23) such as orbital injury or diplopia. Closure of the rhinostoma was seen in 3 cases. granulations noted in one patient.no post operative bleeding noted in group B reported any irritation. Spontaneous extrusion of the prolene stent was not seen in any of the cases. In none of the patients was the stent needed to be removed before 6 weeks. The prolene stenting material did not cause either punctual stenosis or canalicular laceration in any of the cases.

In our present study of 50 cases of chronic dacryocystitis, EnDCR with prolene stenting was performed in 50% of randomly selected patients (GROUP A), and without stenting in the remaining 50% of cases (GROUP B). The purpose of our study is to compare the results of EnDCR with and without prolene stenting and to assess the usage of prolene material as an alternative to silicon stents.  H.Basil Jacobs (1959) in his study found the maximum incidence of this condition between 40-55 years of age1. Sarda et al (1961) noted maximum incidence of chronic dacryocystitis in the third and fourth decade of life 48. R.Dalgleish (1967) stated that 35-40 years was the earliest expected age of onset of acquired idiopathic nasolacrimal duct obstruction11. Our results were similar to those quoted by most authors. Duke Elder states that the disease preferentially affects adults over middle age,being relatively rare in children and adolescents. The highest incidence quoted by him was in the 4th decade of life.

In our study the disease is seen predominantly in the females (82%) Duke Elder states that while the disease in the newborn affects both the sexes equally, its occurence among adults is in the ratio of 75-80% females to 25- 30% males12. H.Basil Jacobs (1959) found a female to male ratio of 3:1 in his series of patients. He claimed that females were more affected by chronic dacryocystitis as they had a higher vascular congestive factor and a narrower bony canal1. R.Dalgleish (1967)11 reported a percentage of 54% amongst females. Saxena R.C. (1969) has an incidence of 84.6%, Mallik,Chatterjee et al (1970) of 71.2%, Nahata of 92% and Sangha S.S. (1979) an incidence of 75% amongst females. Chronic dacryostitis is observed to be common in women of low socio- economic group due to their bad personal habits, long duration of exposure to smoke in kitchen and dust in external environment. Other possible cause could be congenital anatomical narrowing of naso lacrimal drainage system in females as compared to males.

In our study of 50 cases 52% had left sided disease, 42% had right sided disease & 6% had bilateral disease, hence showing that left side is more affected than the right side. It is observed that nasolacrimal duct and lacrimal sac formed a greater angle on right side than left side. It increases the chance of stasis and obstruction of nasolacrimal duct and lacrimal sac on left side. It is, therefore, attributed as the cause for preponderance of chronic dacryosystitis on left side (Arisi 1960). H.Basil Jacobs (1959)1 in his study found that right side was affected 53 times and the left side 37 times in 90 unilateral cases and only 14 cases were bilateral. Dalgleish (1967)11 stated that there was no significant difference in right sided and left sided affection, and that the incidence of bilaterality increases with age. Mallik,Chatterjee et al (1970) reported an increase in left sided blocks (55.8%). Nahata in his series of 30 patients, found that 20 (66.6%) patients had left sided blocks. Stallard (1973) quoted that left side is more affected than the right side. In general, the disease has no predilection to any side as it may affect both the sides equally.

In our study the success rate of En DCR with prolene stenting is 92%. Complete symptomatic relief was seen in 23(92%) cases, & 2(8%) reported no symptomatic relief. Sundus aslan13 in their study of 42 eyes with prolene stent reported a success rate of 92.9%. They reported that the results were very good in 81%, as good in 11.9% and no change in 7.1%. which is similar to our results with prolene stenting. Many variations of endoscopic dacryocystorhinostomy with little modifications like the use of stents, laser and mitomycin-C have been described in the last decade, with equally good results. A bicanalicular silicone tube is the stent most often used in DCR procedures to prevent obliteration of the rhinostomy opening after DCR.

Tamura et al used T- sheet made from a penrose drain tube in seven patients14. They reported that the results were very good in four patients (57%), good in two patients (29%), and showed no change in one patient (14%). In another two reports, kishore et.al15. and Erkan et al16 used standard otologic T- tubes in endoscopic DCR. Erkan reported that the results were very good in 11 patients (50%), good in five patients (23%), and showed no change in six patients (27%).

Thus, the success rate with stent in our study is 92% which is found to correlate well with studies of weidenbacker 1994, Zhou 1996, Yung & Hardman 1998, Bambule & Chamero 2001, PJ Wormland 20022,17,18,19,20. The procedure was a failure in 8% (N=2) in group A. In one patient with failure in group A, granulation tissue was observed around the stent and in one patient there was closure of the rhinostomal opening.

The success rate in group B without stent is 88%. 22 patients reported a complete symptom relief and 3 cases reported no relief in the symptoms. Review of literature shows 82 to 95% success rate with EnDCR.18,21,22,23. The procedure was a failure in 12%(N=3) cases. Closure of the rhinostomal opening was seen in two cases which led to failure and in another patient, there was fibrosis at the rhinostomal opening which led to failure. In our study there was no statistically significant difference found between the surgical out comes in the two groups (p=0.999).

In the present study, patients are assessed subjectively and objectively at ten weeks. Evaluation of postoperative results involves subjective improvement of epiphora (Sperkelsen 1996)24. Some (Metson R 1990, Mauriello J 1999) 25,26 however, used objective methods to monitor patients. Durvasula VSP (2004) has found no need to assess the patients objectively on a long-term basis once the patency of the stoma was observed at three months27.

During our study no major complications were observed. Minor post operative bleed was seen in two cases of group A and a case of group B. Ocular irritation was complained by 3(12%) of the patients of group A which was managed with steroid eye drops and antibiotics and none of the cases in group B. We observed granulation tissue around prolene in one case. Rhinostomal closure was observed in a case of group A and in two cases of group B. Fibrosis of the stomal opening was seen in a case of group B. Spontaneous extrusion of the prolene stent was not seen in any of the cases. In none of the patients was the stent needed to be removed before 6 weeks. The prolene stenting material did not cause either punctual stenosis or canalicular laceration in any of the cases. Hence prolene can be efficiently used as a stenting material in En DCR.

In this study comparing endoscopic dacryocystorhinostomy (En DCR) with and without prolene stenting in 50 cases of chronic dacryocystitis (with prolene used in 50% of randomly divided cases), we conclude, based on the available data and literature, that En DCR is a simple, safe, and minimally invasive procedure offering direct access to the lacrimal sac, making it suitable even for pyocele and mucocele cases, with the added cosmetic benefit of no external scar. Prolene emerges as an excellent non-absorbable stenting material due to its retention of strength, minimal tissue reactivity, slipperiness for easy removal, resistance to bacterial contamination, and blue dye for intranasal visibility; lateral displacement causing ocular discomfort, conjunctivitis, or corneal erosion can be prevented by tying multiple knots in the nasal cavity. As a cost-effective, readily available option in all operating theaters, prolene serves as an effective alternative to routine silicone stents in resource-limited settings, particularly for primary cases with postsaccal or nasolacrimal duct obstruction. Overall, En DCR demonstrates good success rates with or without stenting.

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