|Year : 2017 | Volume
| Issue : 4 | Page : 222-225
Glass ionomer cement: An attractive alternative for the reconstruction of incudostapedial joint discontinuity
BS Yogeesha, K Rohit, Nagaraj Maradi
Department of Otolaryngology, SSIMSRC, Davangere, Karnataka, India
|Date of Web Publication||2-May-2018|
Dr. B S Yogeesha
Department of Otolaryngology, SSIMSRC, Davangere - 577 005, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Chronic suppurative otitis media (CSOM) is a rampant clinical entity in India, and hearing loss is a very debilitating condition which is treatable. Hence, ossiculoplasty is a frequently combined operation with myringoplasty to reconstruct the hearing apparatus of a CSOM patient. Ossiculoplasty can be accomplished through autograft, homograft, and allograft materials. The glass ionomer cement (GIC) included under bone cement is biocompatible and easily available, for restoring the ossicular continuity, more specifically, the incudostapedial joint. Objective: The purpose of this study is to evaluate hearing improvement after repair of ossicular discontinuity between the incus and stapes with GIC. Materials and Methods: This prospective clinical study was conducted in a tertiary care hospital. CSOM patients found to have incudostapedial joint discontinuity intraoperative underwent ossiculoplasty with GIC. Postoperatively, hearing was evaluated at 1 month and 3 months. Audiometric pure-tone threshold by air conduction (AC) was recorded at 0.5, 1, 2, 3, 4, 6, and 8 kHz and by bone conduction at 0.5, 1, 2, 3, and 4 kHz. As per the AAO-CHE guidelines, thresholds at 0.5, 1, 2, and 3 kHz were used to calculate the Pure Tone Average (PTA). The air-bone gap (ABG) was calculated for each patient and the results were tabulated. Results: At the end of each predesignated PTA evaluation, postoperatively, the patients showed improvement in AC thresholds and narrowing of ABG, which was statistically significant. In our study, after applying GIC, the mean AC was 30.89 dB at the end of 3rd month which was significant improvement. Eighteen patients (66.67%) had closure of ABG <20 dB. Interpretation and Conclusion: The current study reveals that tympano-ossicular reconstruction using GIC is a simple, cost-effective method which gives definite good postoperative hearing improvement. Other advantages are more physiological continuity between the incus and stapes, technically easier application, nonextrusion.
Keywords: Audiometry, glass ionomer cement, hearing loss, incudostapedial joint, ossiculoplasty
|How to cite this article:|
Yogeesha B S, Rohit K, Maradi N. Glass ionomer cement: An attractive alternative for the reconstruction of incudostapedial joint discontinuity. Indian J Otol 2017;23:222-5
|How to cite this URL:|
Yogeesha B S, Rohit K, Maradi N. Glass ionomer cement: An attractive alternative for the reconstruction of incudostapedial joint discontinuity. Indian J Otol [serial online] 2017 [cited 2018 Oct 16];23:222-5. Available from: http://www.indianjotol.org/text.asp?2017/23/4/222/231642
| Introduction|| |
Chronic suppurative otitis media (CSOM), with its disease burden of 7.8%, constitutes a major health hazard in India. Yet, it is sadly neglected and underreported, resulting in most of the patients reaching an otolaryngologist in a very advanced stage of the disease. Most of these patients unfortunately have some amount of hearing loss as sequelae. In a culture such as ours, hearing plays a vital role in an individual's day-to-day life. An individual with listening or hearing impairment is denied of key correspondence and is seriously impeded when competing in the present-day world. It brings about lessening of scholastic accomplishment and unsettling influence in social as well as emotional fields. They have diminished portability, have less interpersonal contacts, and are treated in our society as an outcast.
CSOM results in partial or complete loss of tympanic membrane and ossicles, leading to conductive hearing loss that can range in severity up to 60 dB. Congenital malformations or abnormalities of the ear, trauma due to road traffic accidents or associated with head injury, acute or chronic otitis media with or without cholesteatoma, otosclerosis, benign or malignant tumors can damage the middle ear elements requiring surgical reconstruction. Chronic otitis media overtakes the other above-mentioned causes both in importance- and incidence-wise.,
Cholesteatoma is, by a long shot, the most well-known reason, and perpetual otomastoiditis without cholesteatoma can likewise cause disintegration of the ossicles. The pathology could be confined to the incudostapedial joint with loss of the lenticular process. Notwithstanding, there is a complete loss of some allotment of the distal incus. The whole long process of the incus could be dissolved, especially in instances of cholesteatoma, along with the superstructure of the stapes.,
Therefore the goal of tympano-ossicular reconstruction is to eradicate the underlying pathology and to provide a stable and reliable connection between the tympanic membrane and the mobile stapes footplate and to achieve best possible hearing results in long term.
Various allograft materials for ossicular reconstruction are available, but each has their own advantages and disadvantages. In developing country like ours, easy availability and cost factor have to be primarily kept in mind.,
Glass ionomer cement (GIC) is a 2-component bioactive material consisting of inorganic glass particles surrounded by an insoluble hydrogel matrix.,,,, Various investigations since its inception and its use in otologic surgery have revealed that most GIC is biocompatible and biostable and is well tolerated by bone and soft tissues. GIC can be molded, shaped, as well as drilled during surgery. GIC is universally available and cost-effective. During the last 25 years, >2000 reports have been published concerning GIC use in dentistry. However, only a few articles report its use in the middle ear reconstruction surgery of humans.,,
Hence, in this study, we aim to study the effectiveness of GIC as a candidate for ossicular chain reconstruction.
| Materials and Methods|| |
This study was conducted on patients attending the Ear-Nose-Throat (ENT) Department of a tertiary care referral hospital in South India from December 2012 to June 2014, after obtaining clearance from the institutional ethical committee.
Inclusion criteria included patients attending the ENT Outpatient Department with conductive hearing loss and diagnosed to have incudostapedial discontinuity (intraoperative) aged between 11 and 70 years. Exclusion criteria were patients having otosclerosis with stapes fixation, cholesteatoma, tympano-sclerosis, nasal allergy with foci of infection in nose, and chronic conditions such as diabetes, hypertension, and immunocompromised patients. Furthermore, those undergoing staged procedures were excluded.
Patients who satisfied the criteria of selection were admitted 1 day before surgery and underwent detailed evaluation with regard to history, clinical examination, otoscopic examination, patch test, and audiometric evaluation and the details were recorded. X-ray of the mastoids (Schuller's view) was taken. Written informed consent was taken from all the patients before surgery.
All patients underwent tympanoplasty with ossiculoplasty using GIC under general anesthesia. The approach was postaural. After elevating tympano-meatal flap, middle ear inspected for cholesteatoma, condition of the middle ear mucosa, and ossicular status. If the patient was found to have incudostapedial discontinuity, the gap was bridged using GIC. GIC is composed of a sterile powder and a liquid, and both components were mixed on a metal or glass surface in sterile conditions during the operation for 10 s. The mixture was used within 1–3 min. The mixture was then placed between the ossicular chain defects by means of a thin pick to form a bridge. The GIC gets hard 5–7 min after its application. Following hardening, the movement of the ossicles was checked. The graft was then placed by underlay technique, and dry gel foam was used in the middle ear to help stabilize the graft position [Figure 1] and [Figure 2].
|Figure 1: Glass ionomer cement being inserted between incus and stapes intraoperatively|
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|Figure 2: Final picture once glass ionomer cement is hardened after insertion|
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During the follow-up, the patients were compared for following parameters:
- Average hearing threshold on pure-tone audiogram
- Air-bone gap (ABG)
- Graft uptake
- Complications, if any.
Postoperatively, operated ear was evaluated for hearing improvement by pure-tone audiometry (PTA) at 1 month and 3 months. Audiometric pure-tone threshold by air conduction (AC) was recorded at 0.5, 1, 2, 3, 4, 6, and 8 kHz and by bone conduction at 0.5, 1, 2, 3, and 4 kHz. Threshold at 0.5, 1, 2, and 3 kHz was used to calculate the pure-tone average (PTA). The ABG was calculated for each patient.
| Results|| |
Twenty-seven patients satisfied the inclusion criteria of this study during the study period. The age of patients in this study varied between 15 and 55 years. The mean age was 31.63 years (standard deviation [SD] 10.96). The majority of the patients were in the age group of 21–40 years. Of the 27 patients, 15 were male patients (56%) and 12 were female patients (44%). In this study, majority of patients had chief complaints of hearing loss (85%), followed by ear discharge (70%), earache (41%), tinnitus (22%), and dizziness (11%). Twenty-six patients had perforation of the pars tensa (96%), only one patient had pars flaccida perforation (04%). Of the 26 pars tensa perforations, ten were medium-sized, ten were large, four were small, and two were subtotal perforations. Twenty-three had sclerotic mastoids (85%) while four mastoids were pneumatized (15%). It was found that the average AC preoperatively was 42.23 dB (SD 9.63).
Student's paired t-test was applied to the collected data to analyze the gain in hearing at various prespecified intervals with confidence interval set at 99.99% with P < 0.001 being considered significant.
On comparing the improvement in AC in the postoperative period, it was found that there was a change from 42.23 to 36.85 dB at the end of 1 month (P = 0.00286). At the end of 3rd month, the mean AC was 30.89 dB showing significant hearing improvement (P < 0.001).
Similarly, analysis of improvement in ABG during the postoperative period showed that there was a change from 30.25 to 22.89 at the end of 1st postoperative month (P = 0.00106). At the end of 3rd month, the mean ABG was 17 showing significant ABG closure (P < 0.001) [Table 1] and [Table 2].
At the end of the study, 18 patients (66.67%) had closure of ABG <20 dB, of which 10 were male patients (37.03%) and 8 female patients (29.62%).
| Discussion|| |
This study was carried out with the intention of assessing the effectiveness of GIC for the role of bridging incudostapedial discontinuity. In a similar study, on 136 patients with incudostapedial discontinuity by Baglam et al., the postoperative ABG of < 20 dB was attained in 81.6% of patients. The mean preoperative and postoperative pure-tone average of the patients was 52.82 ± 5.59 and 32.81 ± 7.18 dB, respectively (P < 0.01). The mean preoperative and postoperative ABG (in dB) was 35.83 ± 4.735 and 16.54 ± 5.01, respectively (P < 0.01). Baglam et al. in turn notes in their study that the gap between the remnant necrotic incus and the stapes head is likewise imperative when selecting patients. Cases that have gaps less than one-third of incus long arm are perfect candidates for this GIC application. They likewise express in their study that GIC did not meddle with graft uptake rate, as seen in this study.
In 1998, Feghali et al. reported on nine United States patients who underwent reconstruction of an eroded incus, three involving revision stapedectomy, using GIC (OtoCem, Oto-Tech, Raleigh, North Carolina), with encouraging results.
In a study done by Goldenberg and Driver, in patients undergoing ossiculoplasty, the long-term results of 233 patients who underwent ossicular reconstruction with Goldenberg hydroxyapatite prostheses (incus replacement, incus-stapes replacement, partial ossicular replacement prosthesis [PORP] and total ossicular replacement prosthesis [TORP]) revealed an ABG of 21.1 dB in 56.8% of patients with a 5.29% extrusion rate. With the criterion of a postoperative ABG of 20 dB or less, there was an overall success rate of 64.8% for all prostheses. The results were best for incus replacement prosthesis (76%) and the incus-stapes prosthesis (85.7%), with a considerably lower success rates for PORP (44.4%) and the TORP (61.9%). Successful hearing result was reported in 50.6% patients. This study demonstrates higher success rates of incus replacement prostheses compared to PORP and TORP.
Similar observations were made by Brask. In a study on 44 patients, he showed that the postoperative ABG was <20 dB in 83.3%. GIC gave altogether better results and good closure of the ABG compared to conventional prosthesis (autograft, homograft, or hydroxylapatite).
In the study by Babu and Seidman on 80 patients with incudostapedial disarticulation utilizing glass ionomer bond as one of the reconstructing materials, they got results which demonstrated an improvement of ABG from preoperative average of 33–10 dB postoperatively. No patients encountered any worsening of preoperative conductive hearing loss. There were no cases of graft extrusion or infection after bone cement usage in their study. Similarly, in our study, we did not find any such complication, thus establishing the safety of the GIC.
The study done by Bayazit et al. demonstrated that the graft take-up rate was 84.1%. Incus-stapes re-bridging with GIC method was performed in 42 patients and malleus-stapes re-bridging in eight patients. Pre- and post-operative PTA of all patients was looked at, which demonstrated a significant change in air PTA (P < 0.001) while bone PTA did not change (P < 0.05). In incus-stapes and malleus-stapes groups, successful hearing improvement could be accomplished in 78.6.1% and 87.5% of the patients, respectively.
Ozer et al. did incus and stapes re-bridging using GIC and obtained an ABG success rate of 60%. This correlates with the success rate of 66.67% observed in our study. However, Shinohara (2000) reported 68% success rates at 1 year with PORP, in subjects where only the incus needed to be replaced.
Iurato et al. reviewed 290 published reports of results of ossiculoplasty when malleus and stapes superstructure were present. A postoperative ABG of 0–10 dB was achieved in only 50% of patients while 80% had ABG of 0–20 dB. There was no significant difference in hearing outcome between different types of prosthesis.
The demerits of this study are its limited sample size, short-term follow-up, and the noninclusion of indices such as MERI and OOPS in the evaluation of the patients.
We can conclude from this study that GIC does not underachieve in incus to stapes re-bridging when compared to studies that used conventional techniques such as sculpted incus or PORP.
There is no sufficient evidence to prove the superiority of GIC compared to conventional techniques due to variations in sample size characteristics and geography, different socioeconomic conditions of previous studies, varying patient characteristics. We recommend a similar study with larger and more diverse sample and a longer follow-up period to analyze the results of using GIC as an ossiculoplasty material.
We would like to acknowledge Dr. A.M Shivakumar, former Prof and Head, Department of Otolaryngology, SSIMSRC, for his helpful feedback on this study. We wish to thank all doctors, nurses and staff at Department of ENT, SSIMSRC, for helping to make this study a success.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]